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1. Standardizing definitions and terminology of left-sided pancreatic resections through an international Delphi consensus

Author

MS CGO, Cancer, van Ramshorst, Tess M.E., van Hilst, Jony, Boggi, Ugo, Dokmak, Safi, Edwin, Bjørn, Keck, Tobias, Khatkov, Igor, Balduzzi, Alberto, Pulvirenti, Alessandra, Ahmad, Jawad, Saati, Hani Al, Alseidi, Adnan, Ausania, Fabio, Azagra, Juan S., Balzano, Gianpaolo, Björnsson, Bergthor, Can, Fatih M., Cillo, Umberto, D’Hondt, Mathieu, Efanov, Mikhail, Erkan, Mert, Alvarez, Francisco Espin, Esposito, Alessandro, Ferrari, Giovanni, Koerkamp, Bas Groot, Gumbs, Andrew A., Hogg, Melissa E., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin Young, Kleive, Dyre, Kooby, David A., Luyer, Misha D.P., Marchegiani, Giovanni, Menon, Krishna, Molenaar, I. Quintus, Nagakawa, Yuichi, Nakamura, Masafumi, Palumbo, Diego, Piardi, Tullio, Ramia, Jose M., Saint-Marc, Olivier, Salti, George I., Strobel, Oliver, Vollmer, Charles M., Wei, Alice C., White, Steve, Yoon, Yoo Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C.P., Dervenis, Christos, Falconi, Massimo, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Casadei, Riccardo, Coppola, Roberto, Benedetto, Fabrizio Di, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Pietrabissa, Andrea, Portolani, Nazario, Salvia, Roberto, Siriwardena, Ajith K., Asbun, Horacio J., Besselink, Marc G., Hilal, Mohammad Abu, MS CGO, Cancer, van Ramshorst, Tess M.E., van Hilst, Jony, Boggi, Ugo, Dokmak, Safi, Edwin, Bjørn, Keck, Tobias, Khatkov, Igor, Balduzzi, Alberto, Pulvirenti, Alessandra, Ahmad, Jawad, Saati, Hani Al, Alseidi, Adnan, Ausania, Fabio, Azagra, Juan S., Balzano, Gianpaolo, Björnsson, Bergthor, Can, Fatih M., Cillo, Umberto, D’Hondt, Mathieu, Efanov, Mikhail, Erkan, Mert, Alvarez, Francisco Espin, Esposito, Alessandro, Ferrari, Giovanni, Koerkamp, Bas Groot, Gumbs, Andrew A., Hogg, Melissa E., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin Young, Kleive, Dyre, Kooby, David A., Luyer, Misha D.P., Marchegiani, Giovanni, Menon, Krishna, Molenaar, I. Quintus, Nagakawa, Yuichi, Nakamura, Masafumi, Palumbo, Diego, Piardi, Tullio, Ramia, Jose M., Saint-Marc, Olivier, Salti, George I., Strobel, Oliver, Vollmer, Charles M., Wei, Alice C., White, Steve, Yoon, Yoo Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C.P., Dervenis, Christos, Falconi, Massimo, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Casadei, Riccardo, Coppola, Roberto, Benedetto, Fabrizio Di, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Pietrabissa, Andrea, Portolani, Nazario, Salvia, Roberto, Siriwardena, Ajith K., Asbun, Horacio J., Besselink, Marc G., and Hilal, Mohammad Abu

Published
2024

2. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS)

Author

Abu Hilal, Mohammad, Van Ramshorst, Tess M.E., Boggi, Ugo, Dokmak, Safi, Edwin, Bjørn, Keck, Tobias, Khatkov, Igor, Ahmad, Jawad, Al Saati, Hani, Alseidi, Adnan, Azagra, Juan S., Björnsson, Bergthor, Can, Fatih M., D'Hondt, Mathieu, Efanov, Mikhail, Espin Alvarez, Francisco, Esposito, Alessandro, Ferrari, Giovanni, Groot Koerkamp, Bas, Gumbs, Andrew A., Hogg, Melissa E., Huscher, Cristiano G.S., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin Young, Liu, Rong, Luyer, Misha D.P., Menon, Krishna, Nakamura, Masafumi, Piardi, Tullio, Saint-Marc, Olivier, White, Steve, Yoon, Yoo Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C.P., Cook, Andrew, Dervenis, Christos, Falconi, Massimo, Ferrari, Clarissa, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Badran, Ali, Baychorov, Magomet, Bannone, Elisa, Van Bodegraven, Eduard A., Emmen, Anouk M.L.H., Giani, Alessandro, De Graaf, Nine, Van Hilst, Jony, Jones, Leia R., Levi Sandri, Giovanni B., Pulvirenti, Alessandra, Ramera, Marco, Rashidian, Niki, Sahakyan, Mushegh A., Uijterwijk, Bas A., Zampedri, Pietro, Zwart, Maurice J.W., Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Di Benedetto, Fabrizio, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Portolani, Nazario, Ruzzenente, Andrea, Salvia, Roberto, Siriwardena, Ajith K., Besselink, Marc G., Asbun, Horacio J., Abu Hilal, Mohammad, Van Ramshorst, Tess M.E., Boggi, Ugo, Dokmak, Safi, Edwin, Bjørn, Keck, Tobias, Khatkov, Igor, Ahmad, Jawad, Al Saati, Hani, Alseidi, Adnan, Azagra, Juan S., Björnsson, Bergthor, Can, Fatih M., D'Hondt, Mathieu, Efanov, Mikhail, Espin Alvarez, Francisco, Esposito, Alessandro, Ferrari, Giovanni, Groot Koerkamp, Bas, Gumbs, Andrew A., Hogg, Melissa E., Huscher, Cristiano G.S., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin Young, Liu, Rong, Luyer, Misha D.P., Menon, Krishna, Nakamura, Masafumi, Piardi, Tullio, Saint-Marc, Olivier, White, Steve, Yoon, Yoo Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C.P., Cook, Andrew, Dervenis, Christos, Falconi, Massimo, Ferrari, Clarissa, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Badran, Ali, Baychorov, Magomet, Bannone, Elisa, Van Bodegraven, Eduard A., Emmen, Anouk M.L.H., Giani, Alessandro, De Graaf, Nine, Van Hilst, Jony, Jones, Leia R., Levi Sandri, Giovanni B., Pulvirenti, Alessandra, Ramera, Marco, Rashidian, Niki, Sahakyan, Mushegh A., Uijterwijk, Bas A., Zampedri, Pietro, Zwart, Maurice J.W., Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Di Benedetto, Fabrizio, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Portolani, Nazario, Ruzzenente, Andrea, Salvia, Roberto, Siriwardena, Ajith K., Besselink, Marc G., and Asbun, Horacio J.

Abstract

Objective: To develop and update evidence-based and consensus-based guidelines on laparoscopic and robotic pancreatic surgery. Summary Background Data: Minimally invasive pancreatic surgery (MIPS), including laparoscopic and robotic surgery, is complex and technically demanding. Minimizing the risk for patients requires stringent, evidence-based guidelines. Since the International Miami Guidelines on MIPS in 2019, new developments and key publications have been reported, necessitating an update. Methods: Evidence-based guidelines on 22 topics in 8 domains were proposed: terminology, indications, patients, procedures, surgical techniques and instrumentation, assessment tools, implementation and training, and artificial intelligence. The Brescia Internationally Validated European Guidelines on Minimally Invasive Pancreatic Surgery (EGUMIPS, September 2022) used the Scottish Intercollegiate Guidelines Network (SIGN) methodology to assess the evidence and develop guideline recommendations, the Delphi method to establish consensus on the recommendations among the Expert Committee, and the AGREE II-GRS tool for guideline quality assessment and external validation by a Validation Committee. Results: Overall, 27 European experts, 6 international experts, 22 international Validation Committee members, 11 Jury Committee members, 18 Research Committee members, and 121 registered attendees of the 2-day meeting were involved in the development and validation of the guidelines. In total, 98 recommendations were developed, including 33 on laparoscopic, 34 on robotic, and 31 on general MIPS, covering 22 topics in 8 domains. Out of 98 recommendations, 97 reached at least 80% consensus among the experts and congress attendees, and all recommendations were externally validated by the Validation Committee. Conclusions: The EGUMIPS evidence-based guidelines on laparoscopic and robotic MIPS can be applied in current clinical practice to provide guidance to patients, surgeons, policy-m

Published
2024

3. Standardizing definitions and terminology of left-sided pancreatic resections through an international Delphi consensus

Author

van Ramshorst, Tess M. E., van Hilst, Jony, Boggi, Ugo, Dokmak, Safi, Edwin, Bjorn, Keck, Tobias, Khatkov, Igor, Balduzzi, Alberto, Pulvirenti, Alessandra, Ahmad, Jawad, Al Saati, Hani, Alseidi, Adnan, Ausania, Fabio, Azagra, Juan S., Balzano, Gianpaolo, Björnsson, Bergthor, Can, Fatih M., Cillo, Umberto, D'Hondt, Mathieu, Efanov, Mikhail, Erkan, Mert, Espin Alvarez, Francisco, Esposito, Alessandro, Ferrari, Giovanni, Groot Koerkamp, Bas, Gumbs, Andrew A., Hogg, Melissa E., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin-Young, Kleive, Dyre, Kooby, David A., Luyer, Misha D. P., Marchegiani, Giovanni, Menon, Krishna, Molenaar, I. Quintus, Nagakawa, Yuichi, Nakamura, Masafumi, Palumbo, Diego, Piardi, Tullio, Ramia, Jose M., Saint-Marc, Olivier, Salti, George I, Strobel, Oliver, Vollmer, Charles M., Wei, Alice C., White, Steve, Yoon, Yoo-Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C. P., Dervenis, Christos, Falconi, Massimo, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Casadei, Riccardo, Coppola, Roberto, Di Benedetto, Fabrizio, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Pietrabissa, Andrea, Portolani, Nazario, Salvia, Roberto, Siriwardena, Ajith K., Asbun, Horacio J., Besselink, Marc G., Abu Hilal, Mohammad, van Ramshorst, Tess M. E., van Hilst, Jony, Boggi, Ugo, Dokmak, Safi, Edwin, Bjorn, Keck, Tobias, Khatkov, Igor, Balduzzi, Alberto, Pulvirenti, Alessandra, Ahmad, Jawad, Al Saati, Hani, Alseidi, Adnan, Ausania, Fabio, Azagra, Juan S., Balzano, Gianpaolo, Björnsson, Bergthor, Can, Fatih M., Cillo, Umberto, D'Hondt, Mathieu, Efanov, Mikhail, Erkan, Mert, Espin Alvarez, Francisco, Esposito, Alessandro, Ferrari, Giovanni, Groot Koerkamp, Bas, Gumbs, Andrew A., Hogg, Melissa E., Ielpo, Benedetto, Ivanecz, Arpad, Jang, Jin-Young, Kleive, Dyre, Kooby, David A., Luyer, Misha D. P., Marchegiani, Giovanni, Menon, Krishna, Molenaar, I. Quintus, Nagakawa, Yuichi, Nakamura, Masafumi, Palumbo, Diego, Piardi, Tullio, Ramia, Jose M., Saint-Marc, Olivier, Salti, George I, Strobel, Oliver, Vollmer, Charles M., Wei, Alice C., White, Steve, Yoon, Yoo-Seok, Zerbi, Alessandro, Bassi, Claudio, Berrevoet, Frederik, Chan, Carlos, Coimbra, Felipe J., Conlon, Kevin C. P., Dervenis, Christos, Falconi, Massimo, Frigerio, Isabella, Fusai, Giuseppe K., De Oliveira, Michelle L., Pinna, Antonio D., Primrose, John N., Sauvanet, Alain, Serrablo, Alejandro, Smadi, Sameer, Alfieri, Sergio, Berti, Stefano, Butturini, Giovanni, Casadei, Riccardo, Coppola, Roberto, Di Benedetto, Fabrizio, Ettorre, Giuseppe M., Giuliante, Felice, Jovine, Elio, Memeo, Riccardo, Pietrabissa, Andrea, Portolani, Nazario, Salvia, Roberto, Siriwardena, Ajith K., Asbun, Horacio J., Besselink, Marc G., and Abu Hilal, Mohammad

Abstract

Funding Agencies|Intuitive grant for the LEARNBOT European Robotic Pancreatoduodenectomy training programme; DIPLOMA-2 trial; E-MIPS Registry; Medtronic grant for the investigator-initiated DIPLOMA trial; Ethicon grant for the PANDORINA trial; Intuitive for robotic pancreatoduodenectomy training

Published
2024
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4. Pancreatic surgery outcomes: multicentre prospective snapshot study in 67 countries

Author

Fusai, Giuseppe Kito, Ferrone, Cristina, Raptis, Dimitri Aristotle, Abu Hilal, Mohamed, Bassi, Claudio, Besselink, Marc, Conlon, Kevin, Davidson, Brian, Del Chiaro, Marco, Dervenis, Christos, Frigerio, Isabella, Falconi, Massimo, Hackert, Thilo, Harrison, Ewen M., Shrikhande, Shailesh V, Siriwardena, Ajith, Smith, Martin, Wolfgang, Christopher, Borakati, Aditya, Balci, Deniz, Elhadi, Muhammed, Salinas, Camila Hidalgo, Machairas, Nikolaos, Marchegiani, Giovanni, Oba, Atsushi, Oberkofler, Christian, Passas, Ioannis, Ravikumar, Reena, Sanchez Velazquez, Patricia, de Santibanes, Martin, Schnitzbauer, Andreas Anton, Soggiu, Fiammetta, Tamburrino, Domenico, Tinguely, Pascale, Wei, Alice, Zachiotis, Marinos, Bentabak, Kamel, Kacimi, Salah Eddine, Nikfarjam, Mehrdad, Shcherba, Aliaksei, Sergeant, Gregory, Coelho, Gustavo, Torres, Orlando, Belev, Nikolay, Fabrice, Burundi, Tang, Ephraim, Martin, Janet, Diaz, Christian, Devaud, Nicolas, Wei, Kongyuan, Hendi, Maher, Mikulic, Danko, Gouvas, Nikolaos, Christophides, Thalis, Nikov, Andrej, Fathallah, Dalia, Saad, Mahmoud, Tammik, Olav, Huhta, Heikki, Sulpice, Laurent, Lupinacci, Renato, Demetrashvili, Zaza, Stavrou, Gregor A., Felekouras, Evangelos, Papaziogas, Vasileios, Misra, Sanjeev, Diponegoro, Erik Prabowo, Hashim, Hashim Talib, Al-Sader, Maytham Al-Juaifari, Satoi, Sohei, Obeidat, Khaled, Mohsen, Maram, Fakhradiyev, Ildar, Han, Ho-Seong, Khalife, Mohamad, Dulskas, Audrius, Bong, Jin, Ghani, Shahi, Eduardo Padilla, Alejandro, Melchor-Ruan, Javier, Erdene, Sarnai, Benkabbou, Amine, Nashidengo, Pueya, Koea, Jonathan, Adeyeye, Ademola, Alatise, Olusegun, Ullah, Sami, Abu Jayyab, Mustafa, Amro, Sarah, Alnammourah, Walaa Mohammed, The, Catherine, Pedziwiatr, Michal, Polkowski, Wojciech, Barbu, Sorin Traian, Karamarkovic, Aleksandar, Galun, Daniel, Goh, Brian K. P., Trotovsek, Blaz, Omoshoro-Jones, Jones, Ielpo, Benedetto, Abdelmageed, Abdelfatah, Sandström, Per A, Cristaudi, Alessandra, Gloor, Beat, Kuemmerli, Christoph, Tishreen, Alaa Hamdan, Chaaban, Mohammad Karam, Wu, Chien Hui, Jen, Po-Chih Yang Fu, Houssem, Ammar, Baraket, Oussama, Coker, Ahmet, Taylor, Mark, Jamieson, Nigel, Iype, Satheesh, Giorgakis, Emmanouil, Qadan, Motaz, Ganai, Sabha, Al-Naggar, Hamza, Chihaka, Onesai, Fusai, Giuseppe Kito, Ferrone, Cristina, Raptis, Dimitri Aristotle, Abu Hilal, Mohamed, Bassi, Claudio, Besselink, Marc, Conlon, Kevin, Davidson, Brian, Del Chiaro, Marco, Dervenis, Christos, Frigerio, Isabella, Falconi, Massimo, Hackert, Thilo, Harrison, Ewen M., Shrikhande, Shailesh V, Siriwardena, Ajith, Smith, Martin, Wolfgang, Christopher, Borakati, Aditya, Balci, Deniz, Elhadi, Muhammed, Salinas, Camila Hidalgo, Machairas, Nikolaos, Marchegiani, Giovanni, Oba, Atsushi, Oberkofler, Christian, Passas, Ioannis, Ravikumar, Reena, Sanchez Velazquez, Patricia, de Santibanes, Martin, Schnitzbauer, Andreas Anton, Soggiu, Fiammetta, Tamburrino, Domenico, Tinguely, Pascale, Wei, Alice, Zachiotis, Marinos, Bentabak, Kamel, Kacimi, Salah Eddine, Nikfarjam, Mehrdad, Shcherba, Aliaksei, Sergeant, Gregory, Coelho, Gustavo, Torres, Orlando, Belev, Nikolay, Fabrice, Burundi, Tang, Ephraim, Martin, Janet, Diaz, Christian, Devaud, Nicolas, Wei, Kongyuan, Hendi, Maher, Mikulic, Danko, Gouvas, Nikolaos, Christophides, Thalis, Nikov, Andrej, Fathallah, Dalia, Saad, Mahmoud, Tammik, Olav, Huhta, Heikki, Sulpice, Laurent, Lupinacci, Renato, Demetrashvili, Zaza, Stavrou, Gregor A., Felekouras, Evangelos, Papaziogas, Vasileios, Misra, Sanjeev, Diponegoro, Erik Prabowo, Hashim, Hashim Talib, Al-Sader, Maytham Al-Juaifari, Satoi, Sohei, Obeidat, Khaled, Mohsen, Maram, Fakhradiyev, Ildar, Han, Ho-Seong, Khalife, Mohamad, Dulskas, Audrius, Bong, Jin, Ghani, Shahi, Eduardo Padilla, Alejandro, Melchor-Ruan, Javier, Erdene, Sarnai, Benkabbou, Amine, Nashidengo, Pueya, Koea, Jonathan, Adeyeye, Ademola, Alatise, Olusegun, Ullah, Sami, Abu Jayyab, Mustafa, Amro, Sarah, Alnammourah, Walaa Mohammed, The, Catherine, Pedziwiatr, Michal, Polkowski, Wojciech, Barbu, Sorin Traian, Karamarkovic, Aleksandar, Galun, Daniel, Goh, Brian K. P., Trotovsek, Blaz, Omoshoro-Jones, Jones, Ielpo, Benedetto, Abdelmageed, Abdelfatah, Sandström, Per A, Cristaudi, Alessandra, Gloor, Beat, Kuemmerli, Christoph, Tishreen, Alaa Hamdan, Chaaban, Mohammad Karam, Wu, Chien Hui, Jen, Po-Chih Yang Fu, Houssem, Ammar, Baraket, Oussama, Coker, Ahmet, Taylor, Mark, Jamieson, Nigel, Iype, Satheesh, Giorgakis, Emmanouil, Qadan, Motaz, Ganai, Sabha, Al-Naggar, Hamza, and Chihaka, Onesai

Abstract

Background: Pancreatic surgery remains associated with high morbidity rates. Although postoperative mortality appears to have improved with specialization, the outcomes reported in the literature reflect the activity of highly specialized centres. The aim of this study was to evaluate the outcomes following pancreatic surgery worldwide. Methods: This was an international, prospective, multicentre, cross-sectional snapshot study of consecutive patients undergoing pancreatic operations worldwide in a 3-month interval in 2021. The primary outcome was postoperative mortality within 90 days of surgery. Multivariable logistic regression was used to explore relationships with Human Development Index (HDI) and other parameters. Results: A total of 4223 patients from 67 countries were analysed. A complication of any severity was detected in 68.7 percent of patients (2901 of 4223). Major complication rates (Clavien-Dindo grade at least IIIa) were 24, 18, and 27 percent, and mortality rates were 10, 5, and 5 per cent in low-to-middle-, high-, and very high-HDI countries respectively. The 90-day postoperative mortality rate was 5.4 per cent (229 of 4223) overall, but was significantly higher in the low-to-middle-HDI group (adjusted OR 2.88, 95 per cent c.i. 1.80 to 4.48). The overall failure-to-rescue rate was 21 percent; however, it was 41 per cent in low-to-middle-compared with 19 per cent in very high-HDI countries. Conclusion: Excess mortality in low-to-middle-HDI countries could be attributable to failure to rescue of patients from severe complications. The authors call for a collaborative response from international and regional associations of pancreatic surgeons to address management related to death from postoperative complications to tackle the global disparities in the outcomes of pancreatic surgery (NCT04652271; ISRCTN95140761)., Funding Agencies|Fiorina Royal Free Charity, London, UK; Swiss Pancreas Foundation, Berne, Switzerland

Published
2023
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5. Impact of enhanced recovery protocols after pancreatoduodenectomy:meta-analysis

Author

Kuemmerli, Christoph, Tschuor, Christoph, Kasai, Meidai, Alseidi, Adnan A., Balzano, Gianpaolo, Bouwense, Stefan, Braga, Marco, Coolsen, Mariëlle, Daniel, Sara K., Dervenis, Christos, Falconi, Massimo, Hwang, Dae Wook, Kagedan, Daniel J., Kim, Song Cheol, Lavu, Harish, Liang, Tingbo, Nussbaum, Daniel, Partelli, Stefano, Passeri, Michael J., Pecorelli, Nicolò, Pillai, Sastha Ahanatha, Pillarisetty, Venu G., Pucci, Michael J., Su, Wei, Sutcliffe, Robert P., Tingstedt, Bobby, van der Kolk, Marion, Vrochides, Dionisios, Wei, Alice, Williamsson, Caroline, Yeo, Charles J., Zani, Sabino, Zouros, Efstratios, Abu Hilal, Mohammed, Kuemmerli, Christoph, Tschuor, Christoph, Kasai, Meidai, Alseidi, Adnan A., Balzano, Gianpaolo, Bouwense, Stefan, Braga, Marco, Coolsen, Mariëlle, Daniel, Sara K., Dervenis, Christos, Falconi, Massimo, Hwang, Dae Wook, Kagedan, Daniel J., Kim, Song Cheol, Lavu, Harish, Liang, Tingbo, Nussbaum, Daniel, Partelli, Stefano, Passeri, Michael J., Pecorelli, Nicolò, Pillai, Sastha Ahanatha, Pillarisetty, Venu G., Pucci, Michael J., Su, Wei, Sutcliffe, Robert P., Tingstedt, Bobby, van der Kolk, Marion, Vrochides, Dionisios, Wei, Alice, Williamsson, Caroline, Yeo, Charles J., Zani, Sabino, Zouros, Efstratios, and Abu Hilal, Mohammed

Abstract

BACKGROUND: This individual-patient data meta-analysis investigated the effects of enhanced recovery after surgery (ERAS) protocols compared with conventional care on postoperative outcomes in patients undergoing pancreatoduodenectomy. METHODS: The Cochrane Library, MEDLINE, Embase, Scopus, and Web of Science were searched systematically for articles reporting outcomes of ERAS after pancreatoduodenectomy published up to August 2020. Comparative studies were included. Main outcomes were postoperative functional recovery elements, postoperative morbidity, duration of hospital stay, and readmission. RESULTS: Individual-patient data were obtained from 17 of 31 eligible studies comprising 3108 patients. Time to liquid (mean difference (MD) -3.23 (95 per cent c.i. -4.62 to -1.85) days; P < 0.001) and solid (-3.84 (-5.09 to -2.60) days; P < 0.001) intake, time to passage of first stool (MD -1.38 (-1.82 to -0.94) days; P < 0.001) and time to removal of the nasogastric tube (3.03 (-4.87 to -1.18) days; P = 0.001) were reduced with ERAS. ERAS was associated with lower overall morbidity (risk difference (RD) -0.04, 95 per cent c.i. -0.08 to -0.01; P = 0.015), less delayed gastric emptying (RD -0.11, -0.22 to -0.01; P = 0.039) and a shorter duration of hospital stay (MD -2.33 (-2.98 to -1.69) days; P < 0.001) without a higher readmission rate. CONCLUSION: ERAS improved postoperative outcome after pancreatoduodenectomy. Implementation should be encouraged.

Published
2022

6. The Impact of Positive Resection Margins on Survival and Recurrence Following Resection and Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma

Author

Ghaneh, Paula, Kleeff, Jorg, Halloran, Christopher M., Raraty, Michael, Jackson, Richard, Melling, James, Jones, Owain, Palmer, Daniel H., Cox, Trevor F., Smith, Chloe J., O'Reilly, Derek A., Izbicki, Jakob R., Scarfe, Andrew G., Valle, Juan W., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Goldstein, David, Padbury, Robert, Shannon, Jennifer, Dervenis, Christos, Glimelius, Bengt, Deakin, Mark, Anthoney, Alan, Lerch, Markus M., Mayerle, Julia, Olah, Attila, Rawcliffe, Charlotte L., Campbell, Fiona, Strobel, Oliver, Buechler, Markus W., Neoptolemos, John P., Ghaneh, Paula, Kleeff, Jorg, Halloran, Christopher M., Raraty, Michael, Jackson, Richard, Melling, James, Jones, Owain, Palmer, Daniel H., Cox, Trevor F., Smith, Chloe J., O'Reilly, Derek A., Izbicki, Jakob R., Scarfe, Andrew G., Valle, Juan W., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Goldstein, David, Padbury, Robert, Shannon, Jennifer, Dervenis, Christos, Glimelius, Bengt, Deakin, Mark, Anthoney, Alan, Lerch, Markus M., Mayerle, Julia, Olah, Attila, Rawcliffe, Charlotte L., Campbell, Fiona, Strobel, Oliver, Buechler, Markus W., and Neoptolemos, John P.

Abstract

Objective and Background: Local and distant disease recurrence are frequently observed following pancreatic cancer resection, but an improved understanding of resection margin assessment is required to aid tailored therapies Methods: Analyses were carried out to assess the association between clinical characteristics and margin involvement as well as the effects of individual margin involvement on site of recurrence and overall and recurrence-free survival using individual patient data from the European Study Group for Pancreatic Cancer (ESPAC)-3 randomized controlled trial. Results: There were 1151 patients, of whom 505 (43.9%) had an RI resection. The median and 95% confidence interval (CI) overall survival was 24.9 (22.9-27.2) months for 646 (56.1%) patients with resection margin negative R0 >1 mm) tumors, 25.4 (21.6 30.4) months for 146 (12.7%) patients with RI <1 mm positive resection margins, and 18.7 (17.2-21.1) months for 359 (31.2%) patients with R1-direct positive margins (P < 0.001). In multivariable analysis, overall R 1-direct tumor margins, poor tumor differentiation, positive lymph node status, WHO performance status ≥ 1, maximum tumor size, and RI-direct posterior resection margin were all independently significantly associated with reduced overall and recurrence-free survival. Competing risks analysis showed that overall R1-direct positive resection margin status, positive lymph node status. WHO performance status 1, and R1-direct positive superior mesenteric/medial margin resection status were all significantly associated with local recurrence. Conclusions: RI-direct resections were associated with significantly reduced overall and recurrence-free survival following pancreatic cancer resection. Resection margin involvement was also associated with an increased risk for local recurrence.

Published
2019
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7. European evidence-based guidelines on pancreatic cystic neoplasms

Author

Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, Wusten, L., Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, and Wusten, L.

Abstract

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring < 40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter >= 40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule > 5 mm, and MPD diameter > 10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Published
2018
Full Text
View/download PDF

8. European evidence-based guidelines on pancreatic cystic neoplasms

Author

Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, Wusten, L., Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, and Wusten, L.

Abstract

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring < 40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter >= 40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule > 5 mm, and MPD diameter > 10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Published
2018
Full Text
View/download PDF

9. European evidence-based guidelines on pancreatic cystic neoplasms

Author

Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, Wusten, L., Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, and Wusten, L.

Abstract

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring < 40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter >= 40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule > 5 mm, and MPD diameter > 10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Published
2018
Full Text
View/download PDF

10. European evidence-based guidelines on pancreatic cystic neoplasms

Author

Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, Wusten, L., Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, and Wusten, L.

Abstract

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring < 40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter >= 40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule > 5 mm, and MPD diameter > 10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Published
2018
Full Text
View/download PDF

11. European evidence-based guidelines on pancreatic cystic neoplasms

Author

Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, Wusten, L., Del Chiaro, Marco, Besselink, Marc G., Scholten, Lianne, Bruno, Marco J., Cahen, Djuna L., Gress, Thomas M., van Hooft, Jeanin E., Lerch, Markus M., Mayerle, Julia, Hackert, Thilo, Satoi, Sohei, Zerbi, Alessandro, Cunningham, David, De Angelis, Claudio, Giovanni, Marc, de-Madaria, Enrique, Hegyi, Peter, Rosendahl, Jonas, Friess, Helmut, Manfredi, Riccardo, Levy, Philippe, Real, Francisco X., Sauvanet, Alain, Abu Hilal, Mohammed, Marchegiani, Giovanni, Esposito, Irene, Ghaneh, Paula, Engelbrecht, Marc R. W., Fockens, Paul, van Huijgevoort, Nadine C. M., Wolfgang, Christopher, Bassi, Claudio, Gubergrits, Natalya B., Verbeke, Caroline, Kloppel, Gunter, Scarpa, Aldo, Zamboni, Giuseppe, Lennon, Anne Marie, Sund, Malin, Kartalis, Nikolaos, Grenacher, Lars, Falconi, Massimo, Arnelo, Urban, Kopchak, Kostantin V., Oppong, Kofi, McKay, Colin, Hauge, Truls, Conlon, Kevin, Adham, Mustapha, Ceyhan, Guralp O., Salvia, Roberto, Dervenis, Christos, Allen, Peter, Paye, Francois, Bartsch, Detlef K., Lohr, Matthias, Mutignani, Massimiliano, Laukkarinen, Johanna, Schulick, Richard, Valente, Roberto, Seufferlein, Thomas, Capurso, Gabriele, Siriwardena, Ajith, Neoptolemos, John P., Pukitis, Aldis, Segersvard, Ralf, Aghdassi, A., Andrianello, S., Bossuyt, P., Bulow, R., Cardenas-Jaen, K., Cortegoso, P., Fontana, M., Haeberle, L., Heckler, M., Litvin, A., Mann, K., Michalski, C., Michl, P., Nappo, G., Perri, G., Persson, S., Scheufele, F., Sclafani, F., Schmidt, M., Venezia, L., Volker, F., Vullierm, M-P, and Wusten, L.

Abstract

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring < 40 mm without an enhancing nodule. Relative indications for surgery in IPMN include a main pancreatic duct (MPD) diameter between 5 and 9.9 mm or a cyst diameter >= 40 mm. Absolute indications for surgery in IPMN, due to the high-risk of malignant transformation, include jaundice, an enhancing mural nodule > 5 mm, and MPD diameter > 10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Published
2018
Full Text
View/download PDF

12. Index C-reactive protein predicts increased severity in acute sigmoid diverticulitis

Author

Kechagias,Aristotelis, Sofianidis,Anastasios, Zografos,Georgios, Leandros,Emmanouel, Alexakis,Nicholas, Dervenis,Christos, Kechagias,Aristotelis, Sofianidis,Anastasios, Zografos,Georgios, Leandros,Emmanouel, Alexakis,Nicholas, and Dervenis,Christos

Abstract

Aristotelis Kechagias,1,2 Anastasios Sofianidis,1 Georgios Zografos,3 Emmanouel Leandros,3 Nicholas Alexakis,3 Christos Dervenis1 1Department of Surgery, Konstantopouleion Hospital, Athens, Greece; 2Department of Gastrointestinal Surgery, Kanta-Häme Central Hospital, Hämeenlinna, Finland; 3First Department of Propaedeutic Surgery, Hippocratio Hospital, National and Kapodistrian University of Athens, Athens, Greece Purpose: Conservative management is successful in unperforated (Hinchey Ia) acute diverticulitis (AD) and also generally in local perforation or small abscesses (Hinchey Ib). A higher degree of radiological severity (Hinchey >Ib), ie, a larger abscess (>3–4 cm) or peritonitis, commonly requires percutaneous drainage or surgery. Retrospective studies show that high levels of C-reactive protein (CRP) distinguish Hinchey Ia from all cases of minor and major perforations (Hinchey >Ia). The current study aims to evaluate the usefulness of CRP in distinguishing AD with a higher degree of severity (Hinchey >Ib) from cases that can be treated noninvasively (Hinchey Ia/Ib).Methods: Data from consecutive patients with AD were collected prospectively. All underwent computed tomography (CT). Index parameters obtained at the initial evaluation at the emergency unit were analyzed to assess the association with the outcome. The exclusion criteria comprised concomitant conditions that affected CRP baseline levels.Results: Ninety-nine patients were analyzed. Eighty-eight patients had mild radiological grading (Hinchey Ia/Ib) and eleven had severe radiological grading (Hinchey >Ib; median index CRP 80 mg/L vs 236 mg/L, P<0.001). White blood cells, neutrophils/lymphocytes, serum creatinine, serum glucose, generalized peritonitis, generalized abdominal tenderness, urinary symptoms, and index CRP were related to severe disease. Index CRP was the only independent predictor for Hinch

Published
2018

13. Value of multidetector computed tomographic angiography in marginally resectable pancreatic cancer

Author

Fagkrezos,Dimitris, Dervenis,Christos, Triantopoulou,Charikleia, Fagkrezos,Dimitris, Dervenis,Christos, and Triantopoulou,Charikleia

Abstract

Dimitris Fagkrezos,1 Christos Dervenis,2 Charikleia Triantopoulou11Radiology Department, 2Department of Surgery, Konstantopouleio Hospital Neas Ionias, Athens, Greece Background: Pancreatic carcinoma is a common gastrointestinal malignancy. Accurate preoperative imaging helps to avoid unnecessary or unsuccessful surgical procedures and reduce the number of aborted pancreatic resections. The purpose of this review is to determine the role of multidetector computed tomographic angiography (MDCTA), which allows rapid anatomic evaluation, in accurate local and distant staging of marginally resectable pancreatic adenocarcinomas. Methods: Our methodology was based on the systematic search of published papers using PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for the years 2009–2014, reporting on the reliability and diagnostic accuracy of MDCTA in the evaluation of pancreatic cancer resectability. Results: Based on 33 articles analyzed in the review, MDCTA is the most widely available imaging modality for diagnosing and staging patients with pancreatic cancer, and it can be used for the surgical planning, specifically in locally advanced marginally resectable tumors. Conclusion: Accurate pretreatment assessment of resectability is crucial to design appropriate preoperative protocols of the operating team. It is possible to achieve a complete resection at the first instance in some patients who have borderline resectable tumors as predicted on preoperative imaging. Preoperative MDCTA-based grading systems can help identify such patients. This would help to avoid delayed curative resections in such patients and minimize the risk of aborted open–close operations. Keywords: MDCTA, MDCT angiography, borderline resectable tumors

Published
2015

14. Pancreatic Cancer hENT1 Expression and Survival From Gemcitabine in Patients From the ESPAC-3 Trial

Author

Greenhalf, William, Ghaneh, Paula, Neoptolemos, John P., Palmer, Daniel H., Cox, Trevor F., Lamb, Richard F., Garner, Elizabeth, Campbell, Fiona, Mackey, John R., Costello, Eithne, Moore, Malcolm J., Valle, Juan W., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Goldstein, David, Shannon, Jennifer, Dervenis, Christos, Glimelius, Bengt, Deakin, Mark, Charnley, Richard M., Lacaine, Francois, Scarfe, Andrew G., Middleton, Mark R., Anthoney, Alan, Halloran, Christopher M., Mayerle, Julia, Olah, Attila, Jackson, Richard, Rawcliffe, Charlotte L., Scarpa, Aldo, Bassi, Claudio, Buechler, Markus W., Greenhalf, William, Ghaneh, Paula, Neoptolemos, John P., Palmer, Daniel H., Cox, Trevor F., Lamb, Richard F., Garner, Elizabeth, Campbell, Fiona, Mackey, John R., Costello, Eithne, Moore, Malcolm J., Valle, Juan W., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Goldstein, David, Shannon, Jennifer, Dervenis, Christos, Glimelius, Bengt, Deakin, Mark, Charnley, Richard M., Lacaine, Francois, Scarfe, Andrew G., Middleton, Mark R., Anthoney, Alan, Halloran, Christopher M., Mayerle, Julia, Olah, Attila, Jackson, Richard, Rawcliffe, Charlotte L., Scarpa, Aldo, Bassi, Claudio, and Buechler, Markus W.

Abstract

Background Human equilibrative nucleoside transporter 1 (hENT1) levels in pancreatic adenocarcinoma may predict survival in patients who receive adjuvant gemcitabine after resection. Methods Microarrays from 434 patients randomized to chemotherapy in the ESPAC-3 trial (plus controls from ESPAC-1/3) were stained with the 10D7G2 anti-hENT1 antibody. Patients were classified as having high hENT1 expression if the mean H score for their cores was above the overall median H score (48). High and low hENT1-expressing groups were compared using Kaplan-Meier curves, log-rank tests, and Cox proportional hazards models. All statistical tests were two-sided. Results Three hundred eighty patients (87.6%) and 1808 cores were suitable and included in the final analysis. Median overall survival for gemcitabine-treated patients (n = 176) was 23.4 (95% confidence interval [CI] = 18.3 to 26.0) months vs 23.5 (95% CI = 19.8 to 27.3) months for 176 patients treated with 5-fluorouracil/folinic acid (months vs 23.5 (95% CI = 19.8 to 27.3) months for 176 patients treated with 5-fluorouracil/folinic acid (chi(2)(1)=0.24; P = .62). Median survival for patients treated with gemcitabine was 17.1 (95% CI = 14.3 to 23.8) months for those with low hENT1 expression vs 26.2 (95% CI = 21.2 to 31.4) months for those with high hENT1 expression (chi(2)(1)=9.87; P = .002). For the 5-fluorouracil group, median survival was 25.6 (95% CI = 20.1 to 27.9) and 21.9 (95% CI = 16.0 to 28.3) months for those with low and high hENT1 expression, respectively (chi(2)(1) = 0.83; P = .36). hENT1 levels were not predictive of survival for the 28 patients of the observation group (chi(2)(1) = 0.37; P = .54). Multivariable analysis confirmed hENT1 expression as a predictive marker in gemcitabine-treated (Wald chi(2)(1) = 9.16; P = .003) but not 5-fluorouracil-treated (Wald chi(2)(1) = 1.22; P = .27) patients. Conclusions Subject to prospective validation, gemcitabine should not be used for patients with low tumor hENT1

Published
2014
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15. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer : Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)

Author

Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, Francois, Van Laethem, Jean Luc, Aparicio, Thomas, Aust, Daniela, Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, De Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valerie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred, Macarulla, Teresa, Malka, David, Mauer, Muriel, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pelissier, Simone, Collette, Laurence, Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, Francois, Van Laethem, Jean Luc, Aparicio, Thomas, Aust, Daniela, Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, De Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valerie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred, Macarulla, Teresa, Malka, David, Mauer, Muriel, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pelissier, Simone, and Collette, Laurence

Abstract

Background: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Methods: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). Results: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. Conclusion: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.

Published
2014
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16. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

Author

Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, François, Van Laethem, Jean-Luc, Aparicio, Thomas, Aust, Daniela D.E., Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, de Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valérie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred B., Macarulla, Teresa, Malka, D, Mauer, Murielle, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, Van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pélissier, Simone, Collette, Laurence, Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, François, Van Laethem, Jean-Luc, Aparicio, Thomas, Aust, Daniela D.E., Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, de Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valérie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred B., Macarulla, Teresa, Malka, D, Mauer, Murielle, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, Van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pélissier, Simone, and Collette, Laurence

Abstract

Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer., SCOPUS: re.j, info:eu-repo/semantics/published

Published
2014

17. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials).

Author

Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, François, Van Laethem, Jean-Luc, Aparicio, Thomas, Aust, Daniela D.E., Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, de Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valérie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred B., Macarulla, Teresa, Malka, D, Mauer, Murielle, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, Van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pélissier, Simone, Collette, Laurence, Bonnetain, Franck, Bonsing, Bert, Conroy, Thierry, Dousseau, Adelaide, Glimelius, Bengt, Haustermans, Karin, Lacaine, François, Van Laethem, Jean-Luc, Aparicio, Thomas, Aust, Daniela D.E., Bassi, Claudio, Berger, Virginie, Chamorey, Emmanuel, Chibaudel, Benoist, Dahan, Laeticia, de Gramont, Aimery, Delpero, Jean Robert, Dervenis, Christos, Ducreux, Michel, Gal, Jocelyn, Gerber, Erich, Ghaneh, Paula, Hammel, Pascal, Hendlisz, Alain, Jooste, Valérie, Labianca, Roberto, Latouche, Aurelien, Lutz, Manfred B., Macarulla, Teresa, Malka, D, Mauer, Murielle, Mitry, Emmanuel, Neoptolemos, John, Pessaux, Patrick, Sauvanet, Alain, Tabernero, Josep, Taieb, Julien, Van Tienhoven, Geertjan, Gourgou-Bourgade, Sophie, Bellera, Carine, Mathoulin-Pélissier, Simone, and Collette, Laurence

Abstract

Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer., SCOPUS: re.j, info:eu-repo/semantics/published

Published
2014

18. Effect of Adjuvant Chemotherapy With Fluorouracil Plus Folinic Acid or Gemcitabine vs Observation on Survival in Patients With Resected Periampullary Adenocarcinoma : The ESPAC-3 Periampullary Cancer Randomized Trial

Author

Neoptolemos, John P., Moore, Malcolm J., Cox, Trevor F., Valle, Juan W., Palmer, Daniel H., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Dervenis, Christos, Smith, David, Glimelius, Bengt, Charnley, Richard M., Lacaine, Francois, Scarfe, Andrew G., Middleton, Mark R., Anthoney, Alan, Ghaneh, Paula, Halloran, Christopher M., Lerch, Markus M., Olah, Attila, Rawcliffe, Charlotte L., Verbeke, Caroline S., Campbell, Fiona, Buechler, Markus W., Neoptolemos, John P., Moore, Malcolm J., Cox, Trevor F., Valle, Juan W., Palmer, Daniel H., McDonald, Alexander C., Carter, Ross, Tebbutt, Niall C., Dervenis, Christos, Smith, David, Glimelius, Bengt, Charnley, Richard M., Lacaine, Francois, Scarfe, Andrew G., Middleton, Mark R., Anthoney, Alan, Ghaneh, Paula, Halloran, Christopher M., Lerch, Markus M., Olah, Attila, Rawcliffe, Charlotte L., Verbeke, Caroline S., Campbell, Fiona, and Buechler, Markus W.

Abstract

Context Patients with periampullary adenocarcinomas undergo the same resectional surgery as that of patients with pancreatic ductal adenocarcinoma. Although adjuvant chemotherapy has been shown to have a survival benefit for pancreatic cancer, there have been no randomized trials for periampullary adenocarcinomas. Objective To determine whether adjuvant chemotherapy (fluorouracil or gemcitabine) provides improved overall survival following resection. Design, Setting, and Patients The European Study Group for Pancreatic Cancer (ESPAC)-3 periampullary trial, an open-label, phase 3, randomized controlled trial (July 2000-May 2008) in 100 centers in Europe, Australia, Japan, and Canada. Of the 428 patients included in the primary analysis, 297 had ampullary, 96 had bile duct, and 35 had other cancers. Interventions One hundred forty-four patients were assigned to the observation group, 143 patients to receive 20 mg/m2 of folinic acid via intravenous bolus injection followed by 425 mg/m2 of fluorouracil via intravenous bolus injection administered 1 to 5 days every 28 days, and 141 patients to receive 1000 mg/m2 of intravenous infusion of gemcitabine once a week for 3 of every 4 weeks for 6 months. Main Outcome Measures The primary outcome measure was overall survival with chemotherapy vs no chemotherapy; secondary measures were chemotherapy type, toxic effects, progression-free survival, and quality of life. Results Eighty-eight patients (61%) in the observation group, 83 (58%) in the fluorouracil plus folinic acid group, and 73 (52%) in the gemcitabine group died. In the observation group, the median survival was 35.2 months (95%% CI, 27.2-43.0 months) and was 43.1 (95%, CI, 34.0-56.0) in the 2 chemotherapy groups (hazard ratio, 0.86; (95% CI, 0.66-1.11; χ2 = 1.33; P = .25). After adjusting for independent prognostic variables of age, bile duct cancer, poor tumor differentiation, and positive lymph nodes and after conducting multiple regression analysis, the haza

Published
2012
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