Search

Nicola L Barclay,1 Theresa Burkard,1 Edward Burn,1 Antonella Delmestri,1 Andrea Miquel Dominguez,2 Asieh Golozar,3 Carlos Guarner-Argente,4 Francesc Xavier Avilés-Jurado,5 Wai Yi Man,1 Àlvar Roselló Serrano,6 Andreas Weinberger Rosen,7 Eng Hooi Tan,1 Ilona Tietzova,8 Daniel Prieto Alhambra,1,9 Danielle Newby1 On behalf of the OPTIMA Consortium1Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom; 2Otorrinolaringology department, Hospital Joan XXIII de Tarragona, Tarragona, Spain; 3Odysseus Data Services, Cambridge, MA, USA; 4Gastroenterology Department, Hospital de la Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Sant Quintí, Barcelona, Spain; 5Head Neck Tumors Unit, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain; 6Institut Català d’Oncologia, Hospital Universitari Dr Josep Trueta, Girona, Spain; 7Centre for Surgical Science, Department of Surgery, Zealand University Hospital, Koege, Denmark; 8First Department of Tuberculosis and Respiratory Diseases, First Faculty of Medicine, Charles University, Prague, Czech Republic; 9Department of Medical Informatics, Erasmus University Medical Centre, Rotterdam, the NetherlandsCorrespondence: Daniel Prieto Alhambra, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, OX3 7LD, United Kingdom, Email daniel.prietoalhambra@ndorms.ox.ac.ukPurpose: The COVID-19 pandemic profoundly affected healthcare systems and patients. There is a need to comprehend the collateral effects of the pandemic on non-communicable diseases. We examined the impact of the pandemic on short-term survival for common solid tumours, including breast, colorectal, head and neck, liver, lung, oesophageal, pancreatic, prostate, and stomach cancer in the UK.Methods: This was a population-based cohort study of electronic health records from the UK primary care Clinical Practice Research Datalink GOLD database. In sum, 12,259,744 eligible patients aged ≥ 18 years with ≥ 1 year’s history identified from January 2000 to December 2022 were included. We estimated age-standardised incidence and short-term (one- and two-year) survival for several common cancers from 2000 to 2019 (in five-year strata) and compared these to 2020– 2022 using the Kaplan–Meier method.Results: Incidence decreased for most cancers in 2020 and recovered to different extents in 2021– 2022. Short-term survival improved for most cancers between 2000 and 2019, but then declined, albeit minimally, for those diagnosed in 2020– 2022. This was most pronounced for colorectal cancer, with one-year survival falling from 78.8% (95% CI 78%– 79.6%) in 2015– 2019 to 77% (95% CI 75.6– 78.3%) for those diagnosed in 2020– 2022.Conclusion: Short-term survival for many cancers was impacted, albeit minimally, by the pandemic in the UK, with reductions in survivorship from colorectal cancer equivalent to returning to the mortality seen in the first decade of the 2000s. While data on longer-term survival are needed to fully comprehend the impact of COVID-19 on cancer care, our findings illustrate the need for an urgent and substantial commitment from the UK National Health Service to address the existing backlog in cancer screening and diagnostic procedures to improve cancer care and mortality.Keywords: cancer, COVID-19, colorectal cancer, incidence, pandemic, survival

Introduction: Laparoscopic Heller miotomy of achalasia has been classically recognized as the gold standard management in children. There is increasing experience with the peroral endoscopic miotomy (POEM) approach in pediatrics, although the series published are scarce. The objective of this study was to present our experience in primary or secondary treatment of pediatric achalasia by POEM and its clinical success rate., Methods: We performed a retrospective review of pediatric patients with achalasia who underwent POEM in some national centers from October 2016 to January 2023. We evaluated clinical efficacy (Eckardt score ≤3), demographic characteristics, intraoperative, preoperative and postoperative, complications, and follow-up., Results: Fifteen POEM were performed in fourteen pediatric patients (aged 12 to 18 years) with achalasia. POEM was the first line treatment in 11 patients, but 4 (21.3%) had previous treatment: 1 (7,1%) pneumatic balloon dilation and 2 (14,2%) laparoscopic Heller myotomy and 1 (7,1%) previous POEM. The average age was 15 years (SD±1,9). The baseline Eckardt score was 7,5 (SD:±1,8), with the baseline GERD score being 6 (SD:±2,9). There was a Clavien-Dindo grade 2 postoperative adverse event corresponding to mild pneumonia (7,1%). The postoperative Eckardt and GERD score after 12 months of follow-up were 0.7 (SD±1,2) and 0,5 (SD±0,7). The study has a success rate greater than 93%., Conclusions: POEM seems a safe and effective procedure, with a short postoperative period for treatment of pediatric achalasia., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Background: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS., Methods: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat., Clinicaltrials: gov, NCT03100578., Results: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015)., Conclusions: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed., Trial Registration Number: ClinicalTrials.gov, NCT03100578., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction and Aims: The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique., Material and Methods: Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection., Results: A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n=79; 95%CI: 68%-84%) and 63.7% (n=65; 95%CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n=55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n=25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14months, 20patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%)., Conclusions: In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Background and Aim: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with long-term indwell of lumen-apposing metal stents (LAMS)., Methods: This study is a multicenter prospective observational study on consecutive high surgical-risk patients requiring gallbladder drainage who underwent EUS-GBD with LAMS over 12 months. Centralized telephone follow-up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE-free survival was determined using log-rank tests. Cumulative risks were estimated using life-table analysis., Results: Eighty-two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5-89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow-up; 45 patients (54.9%) completed 1-year follow-up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47-367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1-year cumulative risk of recurrent biliary events was 9.7% (4.1-21.8%). The 1-year risk of AEs and of severe AEs was 18.8% (11-31.2%) and 7.9% (3.3-18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs., Conclusions: Long-term LAMS indwell does not increase the risk of delayed AEs following EUS-GBD., (© 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

The Human Machine Interface (HMI) of intraluminal robots has a crucial impact on the clinician's performance. It increases or decreases the difficulty of the tasks, and is connected to the users' physical and mental stress., Objective: This article presents a framework to compare and evaluate different HMIs for robotic colonoscopy, with the objective of identifying the optimal HMI that minimises the clinician's effort and maximises the clinical outcomes., Methods: The framework comprises a 1) a virtual simulator (clinically validated), 2) wearable sensors measuring the cognitive load, 3) a data collection unit of metrics correlated to the clinical performance, and 4) questionnaires exploring the users' impressions and perceived stress. The framework was tested with 42 clinicians investigating the optimal device for tele-operated control of robotic colonoscopes. Two control devices were selected and compared: a haptic serial-kinematic device and a standard videogame joypad., Results: The haptic device was preferred by the endoscopists, but the joypad enabled better clinical performance and reduced cognitive and physical load., Conclusion: The framework can be used to evaluate different aspects of a HMI, both hardware and software, and determine the optimal HMI that can reduce the burden on clinicians while improving the clinical outcome., Significance: The findings of this study, and of future studies performed with this framework, can inform the design and development of HMIs for intraluminal robots, leading to improved clinical performance, reduced physical and mental stress for clinicians, and ultimately better patient outcomes.

Colonoscopy (CS) is an invasive diagnostic and therapeutic technique, allowing the study of the colon. It is a safe and well tolerated procedure. However, CS is associated with an increased risk of adverse events, insufficient preparation and incomplete examinations in the elderly or frail patient (PEA/F). The objective of this position paper was to develop a set of recommendations on risk assessment, indications and special care required for CS in the PEA/F. It was drafted by a group of experts appointed by the SCD, SCGiG and CAMFiC that agreed on eight statements and recommendations, between them to recommend against performing CS in patients with advanced frailty, to indicate CS only if the benefits clearly outweigh the risks in moderate frailty and to avoid repeating CS in patients with a previous normal procedure. We also recommended against performing screening CS in patients with moderate or advanced frailty., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Background and Aims: Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs., Methods: This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety., Results: Of 273 patients screened, 122 (62.3% women; mean age, 60.9 ± 13.2 years) were included with SETs (mean size, 9 ± 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the ≤10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93)., Conclusions: EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs ≤10 mm are the best candidates. (Clinical trial registration number: NCT03247231.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Introduction: Endoscopic vacuum therapy (EVT) is a novel technique for closing upper gastrointestinal (UGI) defects. Available literature includes single-center retrospective cohort studies with small sample sizes. Furthermore, evidence about factors associated with EVT failure is scarce. We aimed to assess the efficacy and safety of EVT for the resolution of UGI defects in a multicenter study and to investigate the factors associated with EVT failure and in-hospital mortality., Methods: This is a prospective cohort study in which consecutive EVT procedures for the treatment of UGI defects from 19 Spanish hospitals were recorded in the national registry between November 2018 and March 2022., Results: We included 102 patients: 89 with anastomotic leaks and 13 with perforations. Closure of the defect was achieved in 84 cases (82%). A total of 6 patients (5.9%) had adverse events related to the EVT. The in-hospital mortality rate was 12.7%. A total of 6 patients (5.9%) died because of EVT failure and 1 case (0.9%) due to a fatal adverse event. Time from diagnosis of the defect to initiation of EVT was the only independent predictor for EVT failure (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05, P = 0.005). EVT failure (OR 24.5, 95% CI 4.5-133, P = 0.001) and development of pneumonia after EVT (OR 246.97, 95% CI 11.15-5,472.58, P = 0.0001) were independent predictors of in-hospital mortality., Discussion: EVT is safe and effective in cases of anastomotic leak and perforations of the upper digestive tract. The early use of EVT improves the efficacy of this technique., (Copyright © 2023 by The American College of Gastroenterology.)

Background: Removing lumen-apposing metal stents (LAMSs) may be difficult and even harmful, but these features have seldom been analyzed. We aimed to generate a comprehensive assessment of the feasibility and safety of LAMS retrieval procedures., Methods: A prospective multicenter case series including all technically successfully deployed LAMSs between January 2019 and January 2020 that underwent endoscopic stent removal. All retrieval-related data were prospectively recorded using standardized telephone questionnaires as part of centralized follow-up that ended after stent removal had been performed. Multivariable logistic regression models assessed the potential risk factors for complex removal., Results: For the 407 LAMSs included, removal was attempted in 158 (38.8 %) after an indwell time of 46.5 days (interquartile range [IQR] 31-70). The median (IQR) removal time was 2 (1-4) minutes. Removal was labelled as complex in 13 procedures (8.2 %), although advanced endoscopic maneuvers were required in only two (1.3 %). Complex removal risk factors were stent embedment (relative risk [RR] 5.84, 95 %CI 2.14-15.89; P  = 0.001), over-the-wire deployment (RR 4.66, 95 %CI 1.60-13.56; P  = 0.01), and longer indwell times (RR 1.14, 95 %CI 1.03-1.27; P  = 0.01). Partial and complete embedment were observed in 14 (8.9 %) and five cases (3.2 %), respectively. The embedment rate during the first 6 weeks was 3.1 % (2/65), reaching 15.9 % (10/63) during the following 6 weeks ( P  = 0.02). The adverse event rate was 5.1 %, including seven gastrointestinal bleeds (5 mild, 2 moderate)., Conclusions: LAMS removal is a safe procedure, mostly requiring basic endoscopic techniques attainable in conventional endoscopy rooms. Referral to advanced endoscopy units should be considered for stents with known embedment or long indwell times, which may require more technically demanding procedures., Competing Interests: M. Perez-Miranda is a consultant for Boston Scientific, Olympus, Medtronic, and M.I.Tech. The remaining authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background and Aims: Traditionally, palliative treatment of malignant gastric outlet obstruction (GOO) has been surgical, but surgical treatment carries significant morbidity and mortality rates. Endoscopic placement of a duodenal self-expandable metal stent (D-SEMS) has been proven to be successful for this indication in the short term. However, D-SEMSs are likely to malfunction over time. EUS-guided gastroenterostomy (EUS-GE) may help overcome these limitations. We aimed to evaluate stent failure-free survival at 3 months., Methods: A nationwide multicenter, observational study of D-SEMS and EUS-GE procedures for patients with malignant GOO was conducted at 7 academic centers from January 2015 to June 2020. Stent failure-free survival at 1, 3, and 6 months; technical and clinical success; adverse events (AEs); and patient survival were evaluated in both groups and compared., Results: Ninety-seven patients were included in the D-SEMS group and 79 in the EUS-GE group. Pancreatic cancer was the main underlying malignancy in 53.4%. No statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found. AE rates did not differ between groups (10.3% vs 10.1%), although 2 events in the EUS-GE group required surgical management. Patients in the EUS-GE group had improved stent patency when compared with those patients in the D-SEMS group at 3 months (92.23% vs 80.6%; adjusted hazard ratio, .37; P = .033)., Conclusions: EUS-GE seems to have improved patency outcomes when compared with D-SEMS placement for palliative treatment of malignant GOO. Prospective trials are needed to fully compare their efficacy and AE profile., (Published by Elsevier Inc.)

Background and Study Aims: Data from Japanese series show that surface morphology of laterally spreading tumors (LST) in the colon identifies lesions with different incidence and pattern of submucosal invasion. Such data from western countries are scarce. We compared clinical and histological features of LST in a western country and an eastern country, with special interest on mucosal invasiveness of LST, and investigated the effect of clinical factors on invasiveness in both countries., Patients and Methods: Patients with LST lesions ≥20mm were included from a multicenter prospective registry in Spain and from a retrospective registry from the National Cancer Center Hospital East, Japan. The primary outcome was the presence of submucosal invasion in LST. The secondary outcome was the presence of high-risk histology, defined as high-grade dysplasia or submucosal invasion., Results: We evaluated 1102 patients in Spain and 663 in Japan. Morphological and histological characteristics differed. The prevalence of submucosal invasion in Japan was six-fold the prevalence in Spain (Prevalence Ratio PR=5.66; 95%CI: 3.96, 8.08), and the prevalence of high-risk histology was 1.5 higher (PR=1.44; 95%CI: 1.31, 1.58). Compared to the granular homogeneous type and adjusted by clinical features, granular mixed, flat elevated, and pseudo-depressed types were associated with higher odds of submucosal invasion in Japan, whereas only the pseudo-depressed type showed higher risk in Spain. Regarding high-risk histology, both granular mixed and pseudo-depressed were associated with higher odds in Japan, compared with only the granular mixed type in Spain., Conclusion: This study reveals differences in location, morphology and invasiveness of LST in an eastern and a western cohort., (Copyright © 2021 Elsevier España, S.L.U. All rights reserved.)

Background & Aims: Few prospective studies have assessed the safety of direct oral anticoagulants (DOACs) in elective endoscopy. Our primary aim was to compare the risks of endoscopy-related gastrointestinal bleeding and thromboembolic events in patients on DOACs or vitamin K antagonists (VKAs) in this setting. Secondarily, we examined the impact of the timing of anticoagulant resumption on the risk of delayed bleeding in high-risk therapeutic procedures., Methods: We conducted a multicenter, prospective, observational study from January 2018 to March 2020 of 1602 patients on oral anticoagulants (1004 on VKAs and 598 on DOACs) undergoing 1874 elective endoscopic procedures. Our primary outcomes were 90-day thromboembolic events and 30-day endoscopy-related gastrointestinal bleeding. The inverse probability of treatment weighting propensity score method was used for baseline covariate adjustment., Results: The 2 groups had similar risks of endoscopy-related gastrointestinal bleeding (VKAs vs DOACs, 6.2% vs 6.7%; adjusted odds ratio [OR], 1.05; 95% CI, 0.67-1.65) and thromboembolic events (VKAs vs DOACs, 1.3% vs 1.5%; adjusted OR, 0.90; 95% CI, 0.34-2.38). In high bleeding risk procedures (n = 747), delayed anticoagulant resumption (> 48 hours or 24-48 hours vs < 24 hours) did not reduce the risk of postprocedural bleeding (10.3%, 9%, and 5.8%, respectively; adjusted P = .43). Hot and cold snare polypectomy were the most frequent high-risk interventions (41.8% and 39.8%, respectively)., Conclusion: In a prospective study of patients on DOACs or VKAs undergoing elective endoscopy, endoscopy-related bleeding and thromboembolic events showed similar risk. Our study suggests that early anticoagulant resumption is safe in most patients, but more data are needed for advanced high-risk therapeutic procedures., (Copyright © 2022 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Endoscopic necrosectomy through lumen apposition metal stents (LAMS) is increasingly being used for complicated walled-off pancreatic necrosis (WOPN), but the need for necrosectomy after stent placement is not well understood. The aim of this study was to evaluate clinical, endoscopic, and radiologic predictors of the need for necrosectomy in patients treated with LAMS., Methods: We retrospectively reviewed patients with WOPN treated with LAMS from 2014 to 2017. Necrosectomy was performed only in patients who had recurrent fever or hemodynamic instability during follow-up. Univariate and multivariate analyses were performed., Results: We included 15 patients, 67% men and median age was 75 (54-76) years. Two (13%) presented adverse events, one immediate and one delayed. In the first case, the stent migrated to the gastric cavity during deployment but was relocated in the same procedure. In the second case, the patient presented bleeding on day 36 due to a pseudoaneurysm that was successfully treated with embolization. Clinical success was 100%, but five patients (33%) required endoscopic necrosectomy (4 mechanical and 1 irrigation) and one (7%) required surgical necrosectomy of distant collections. The percentage of necrosis in the collection detected in a previous CT scan (45 [35-66]% vs 10 [5-17]%) was the only factor to predict the need for necrosectomy in the multivariate analysis (OR 1.18 [1.01-1.39])., Conclusion: LAMS is efficient to treat WOPN but more than a third will need necrosectomy. The percentage of necrosis in the collection detected in the CT scan seems to predict the need for necrosectomy., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.)