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Background & Aims: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients., Methods: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events., Results: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred., Conclusions: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.)., (Copyright © 2021. Published by Elsevier Inc.)

Liver abscesses are rare entities for which percutaneous drainage is traditionally employed. The technique is simple, but associated with a significant rate of side effects and patient discomfort. We herein report a case of fungal left liver lobe abscess that was successfully treated by using EUS-guided drainage, with insertion of a large caliber lumen-apposing metal stent. The literature review we performed on the topic seems to favor, at least for abscess in the left and/or caudate liver lobes, EUS as compared to percutaneous drainage., (© 2021 Felice Molinario et al., published by Sciendo.)

Background and Aims: Endoscopic therapy of benign biliary strictures with multiple plastic stent (MPS) placement has shown satisfactory results. However, the literature describes various benign biliary stricture etiologies. The aim of this study was to evaluate long-term MPS results in patients with postcholecystectomy biliary strictures (PCBSs)., Methods: PCBS patients without complete bile duct transection were included. ERCP consisted of placing an increasing plastic stent number over time, exchanged at regular intervals (3-4 months), until complete morphologic stricture disappearance. After stent removal, patient follow-up comprised liver function tests and clinical assessment., Results: One hundred fifty-four patients (43.5% men; mean age, 53 years) were enrolled; in 43% of the cases, PCBSs were involved or were close to the main hepatic confluence. PCBS resolution rate was 96.7% (n = 149). A mean maximum number of 4.3 ± 1.6 stents were placed side-by-side; a mean of 4.2 ± 1.5 ERCPs per patient was needed to obtain PCBS resolution during a mean treatment period of 11.8 ± 6.4 months. Unscheduled stent exchange because of cholangitis, jaundice, or pain occurred in 7.4% of cases. Procedure-related mortality was absent. Follow-up data were available in 85.2% of cases. After a mean follow-up of 11.1 ± 4.9 years, stricture recurrence rate was 9.4% (n = 12). Subsequent to retreatment, 83.3% of patients (n = 10) were asymptomatic after a mean time of 9 years, whereas 2 patients underwent hepaticojejunostomy because of failed retreatment. Statistical analysis revealed no risk factors for PCBS recurrence after MPS., Conclusions: Endoscopic therapy of PCBSs with MPSs is safe and effective at long-term follow-up. PCBSs involving or close to the main hepatic confluence were successfully treated with MPSs. PCBS recurrence rate is low and can be successful endoscopically retreated without precluding possible surgical treatment., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Dominant pancreatic duct strictures in chronic pancreatitis are often managed by endoscopic placement of a single plastic stent. Insertion of multiple plastic stents (MPS) has been proven to be effective in managing refractory strictures, but data are still limited. The aim of this study was to investigate the efficacy and long-term results of MPS to dilate pancreatic duct strictures in chronic pancreatitis., Methods: 48 patients (34 men; mean age 44 years) with chronic pancreatitis and a single pancreatic stent through a refractory stricture in the pancreatic head underwent the following protocol: 1) removal of the single pancreatic stent; 2) balloon dilation of the stricture; 3) insertion of the maximum number of stents; 4) stent removal after 6 - 12 months., Results: The median number of pancreatic plastic stents placed was 3 (diameter 7 - 11.5 Fr, length 3 - 7 cm). Five patients (10.4 %) had persistent strictures after MPS removal. During a mean follow-up of 9.5 years (0.3 - 15.5 years) after stent removal, 74.4 % (32/43) of the patients were asymptomatic, and 25.6 % (11/43) experienced pancreatitis recurrence or pancreatic type pain after a mean time of 26.4 months (8/43, 18.6 % underwent plug extraction without evidence of stricture recurrence; 3/43, 7.0 % had stricture recurrence). No major complications were recorded., Conclusion: Endoscopic multiple plastic stenting of chronic pancreatitis-related pancreatic duct strictures showed satisfactory long-term results, with the option of re-treatment. This procedure can be considered an important therapeutic alternative for painful pancreatic duct strictures located in the head of the pancreas in the setting of chronic pancreatitis., Competing Interests: Andrea Tringali was a consultant for Boston Scientific Corp. Ivo Boškoski is a consultant for Apollo Endosurgery. Dr. Costamagna was supported by grants or donations from Olympus. He is also a member of advisory committees or review panels for Boston Scientific and Cook Endoscopy., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims: Cholelithiasis is the most common biliary tract disorder. Surgery is the treatment of choice for symptomatic gallstones. Aims of this study were to investigate the feasibility and short-term safety of a new endoscopic procedure with a specially designed Nitinol gallbladder stent for blockage of gallstone migration, the Shai™ Stent. The Shai stent is designed to enable free bile flow, which will be supposed to prevent recurrent attacks., Methods: The Shai™ Stent was inserted into the gallbladder during a standard ERCP procedure using a conventional metal stent delivery system. The aim of the present study was to investigate the feasibility and safety of insertion and deployment and removal of the stent into the gallbladder of pigs. In addition, the short-term safety of the stent was evaluated., Results: Fifteen stents were placed in the gallbladder of 15 pigs. Mean procedure time was 25 min (15-37). The maximum follow-up before sacrifice was 42 days. The stent in 1 pig had migrated at the 42 days follow-up but there were no macroscopic changes in its gallbladder or other organs. The stent remained in place in the remaining 12 pigs at autopsy, and the gallbladder and bile ducts were macroscopically normal. Stent removal was easily done in two pigs immediately after placement., Conclusions: Correct placement and removal of the Shai™ Stent in the gallbladder is safe and feasible in pigs. Further clinical trials are warranted to confirm these results and to effectively evaluate the capability of this stent as an innovative biotechnology to block gallstones from migration and impaction.

Background: Endoscopic placement of SEMSs for malignant hilar biliary strictures (MHBS) is well-established palliative treatment for inoperable patients. Objectives of this study were evaluation of survival and stents patency after placement of multiple SEMS for palliation of complex MHBS., Methods: Retrospective review of patients with MHBS that underwent ERCP with insertion of multiple SEMSs for palliation. Survival-associated factors and stents patency were analyzed by Cox multivariate analysis., Results: Between January 1998 and January 2015, 740 patients with nonoperable MHBS that underwent ERCP were identified and only 18.2% of these received multiple SEMSs. Complications were observed in 7.5% of the patients with no procedure-related mortality. Palliative therapies (chemotherapy, external beam radiotherapy and high dose rate brachytherapy) were done in some patients, and outcomes were evaluated. Overall mean survival of the 134 patients was 323 days. Of these, 59% did not had stents malfunction while 41% patients had episodes of SEMSs malfunction and mean survival after re-interventions was 502.9 days. Survival was not influenced by type of tumor, sex or age., Conclusions: Endoscopic multiple SEMSs placement is safe and effective in patients with complex MHBS. Survival is independent from the type and complexity of MHBS while is prolonged in patients undergoing HDR brachytherapy. Prompt recognition of SEMSs malfunction is fundamental for survival., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: The most appropriate endo-therapeutic approach to biliary anastomotic strictures is yet to be defined., Aim: To retrospectively report on the endo-therapy of duct-to-duct anastomotic strictures during 2013 in Italy., Methods: Data were collected from 16 Endoscopy Units at the Italian Liver Transplantation Centers (BASALT study group)., Results: Complete endo-therapy and follow-up data are available for 181 patients: 101 treated with plastic multistenting, 26 with fully covered self-expandable metal stenting and 54 with single stenting. Radiological success was achieved for 145 patients (80%), that is, 88% of plastic multistenting, 88% of self-expandable metal stenting and 61% of single stenting (P < 0.001 vs plastic multistenting; P < 0.05 vs self-expandable metal stenting). After first-line endo-therapy failure, the patients underwent a second-line endo-therapy with plastic multistenting for 25%, fully covered self-expandable metal stenting for 53% and single stenting for 22% of cases, and radiological success was achieved for 84%, that is, 100%, 85% and 63% with plastic multistenting, self-expandable metal stenting and single stenting (P < 0.05 vs plastic multistenting or self-expandable metal stenting) respectively. Procedure-related complications occurred in 7.8% of endoscopic retrograde cholangiopancreatographies. Overall, clinical success was achieved in 87% of patients after a median follow-up of 25 months., Conclusion: Plastic multistenting is confirmed as the preferred first-line treatment, while fully covered self-expandable metal stenting as rescue option for biliary anastomotic strictures. Single stenting has sub-optimal results and should be abandoned., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background and Aims: Anastomotic biliary stricture (ABS) is the most common biliary complication after orthotopic liver transplantation (OLT) and can be successfully managed endoscopically. The long-term results of a protocol using placement of multiple plastic stents to treat ABS following OLT were analyzed., Methods: All patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for OLT-related biliary complications at our Endoscopy Unit between July 1994 and March 2012 were retrospectively identified from the ERCP database. Patients with an ABS treated with an increasing number of plastic stents were included in the study. Follow-up after stent removal was obtained by telephone contact with the patient and/or referring physician and by liver function tests (LFTs) evaluation., Results: 56 patients, treated with an increasing number of plastic stents until resolution of the stricture, were included. Five patients were then excluded (unrelated death during treatment, n = 3; incomplete treatment because of poor compliance, n = 2), and 51/56 patients reached study end points and were included in the analysis. Resolution of ABS was obtained in 50/51 patients; 1 patient required hepaticojejunostomy because of failure to pass the stricture with the guidewire (per protocol resolution, 98 %). Mean duration of endoscopic treatment was 11.5 months, with a median 4 ERCPs per patient. Immediate ERCP-related adverse events occurred in 3/56 patients (5.4 %). After a median follow-up of 5.8 years from stent removal, 3/50 patients (6 %) had recurrence of ABS. These 3 patients were successfully treated again endoscopically and are asymptomatic after a further median follow-up of 5.6 years., Conclusions: At long-term follow-up, endoscopic treatment with multiple plastic stents of ABS following OLT appeared to be effective in most patients. Stricture recurrence is rare and can be successfully treated again endoscopically., (© Georg Thieme Verlag KG Stuttgart · New York.)

Photodynamic therapy (PDT) is a new therapeutic approach for the palliative treatment of malignant bile duct obstruction. In this study, we designed photosensitizer-embedded self-expanding nonvascular metal stent (PDT-stent) which allows repeatable photodynamic treatment of cholangiocarcinoma without systemic injection of photosensitizer. Polymeric photosensitizer (pullulan acetate-conjugated pheophorbide A; PPA) was incorporated in self-expanding nonvascular metal stent. Residence of PPA in the stent was estimated in buffer solution and subcutaneous implantation on mouse. Photodynamic activity of PDT-stent was evaluated through laserexposure on stent-layered tumor cell lines, HCT-116 tumor-xenograft mouse models and endoscopic intervention of PDT-stent on bile duct of mini pigs. Photo-fluorescence imaging of the PDT-stent demonstrated homogeneous embedding of polymeric Pheo-A (PPA) on stent membrane. PDT-stent sustained its photodynamic activities at least for 2 month. And which implies repeatable endoscopic PDT is possible after stent emplacement. The PDT-stent after light exposure successfully generated cytotoxic singlet oxygen in the surrounding tissues, inducing apoptotic degradation of tumor cells and regression of xenograft tumors on mouse models. Endoscopic biliary in-stent photodynamic treatments on minipigs also suggested the potential efficacy of PDT-stent on cholangiocarcinoma. In vivo and in vitro studies revealed our PDT-stent, allows repeatable endoscopic biliary PDT, has the potential for the combination therapy (stent plus PDT) of cholangiocarcinoma., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background & Aims: Fully covered self-expanding metal stents (FCSEMS) are gaining acceptance for the treatment of benign biliary strictures. We performed a large prospective multinational study to study the ability to remove these stents after extended indwell and the frequency and durability of stricture resolution., Methods: In a nonrandomized study at 13 centers in 11 countries, 187 patients with benign biliary strictures received FCSEMS. Removal was scheduled at 10-12 months for patients with chronic pancreatitis or cholecystectomy and at 4-6 months for patients who received liver transplants. The primary outcome measure was removal success, defined as either scheduled endoscopic removal of the stent with no removal-related serious adverse events or spontaneous stent passage without the need for immediate restenting., Results: Endoscopic removal of FCSEMS was not performed for 10 patients because of death (from unrelated causes), withdrawal of consent, or switch to palliative treatment. For the remaining 177 patients, removal success was accomplished in 74.6% (95% confidence interval [CI], 67.5%-80.8%). Removal success was more frequent in the chronic pancreatitis group (80.5%) than in the liver transplantation (63.4%) or cholecystectomy (61.1%) groups (P = .017). FCSEMS were removed by endoscopy from all patients in whom this procedure was attempted. Stricture resolution without restenting upon FCSEMS removal occurred in 76.3% of patients (95% CI, 69.3%-82.3%). The rate of resolution was lower in patients with FCSEMS migration (odds ratio, 0.22; 95% CI, 0.11-0.46). Over a median follow-up period of 20.3 months (interquartile range, 12.9-24.3 mo), the rate of stricture recurrence was 14.8% (95% CI, 8.2%-20.9%). Stent- or removal-related serious adverse events, most often cholangitis, occurred in 27.3% of patients. There was no stent- or removal-related mortality., Conclusions: In a large prospective multinational study, removal success of FCSEMS after extended indwell and stricture resolution were achieved for approximately 75% of patients. ClincialTrials.gov number, NCT01014390., (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: Removal of biliary Fully Covered Self Expandable Metal Stents can fail due to stent migration and/or hyperplastic ingrowth/overgrowth., Methods: A case series of 5 patients with benign biliary strictures (2 post-cholecystectomy, 2 following liver transplantation and 1 related to chronic pancreatitis) is reported. The biliary stricture was treated by temporary insertion of Fully Covered Self Expandable Metal Stents. Stent removal failed due to proximal stent migration and/or overgrowth. Metal stent removal was attempted a few weeks after the insertion of another Fully Covered Metal Stent into the first one., Results: The inner Fully Covered Self Expandable Metal Stent compressed the hyperplastic tissue, leading to the extraction of both the stents in all cases. Two complications were reported as a result of the attempt to stents removal (mild pancreatitis and self-limited haemobilia)., Conclusion: In the present series, the "SEMS in SEMS" technique revealed to be effective when difficulties are encountered during Fully Covered Self Expandable Metal Stents removal., (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Malignant gastric outlet obstruction is often treated by stent placement., Objective: To investigate the outcomes of stent placement in the palliative treatment of malignant neoplasms., Design: Prospective, observational, multicenter registry., Setting: Six tertiary care centers in 5 countries., Patients: A total of 108 adult patients with malignant gastric outlet obstruction., Interventions: Placement of an uncovered, self-expandable, metal duodenal stent., Main Outcome Measurements: The primary endpoint was stent patency at 14 days after stent implantation. Secondary endpoints included stent patency at 1, 2, 3, and 6 months, gastric outlet obstruction scoring system (GOOSS) scores at 14 days and 1, 2, 3, and 6 months after stent deployment, technical success, adverse events, and patient survival (ie, confirmed duration of the implant)., Results: Technical success was achieved in 99.1% of stent placements. Stent patency at 14 days was 94.6%. Kaplan-Meier estimates of stent patency were 92.9% at 1 month, 86.2% at 2 months, 81.9% at 3 months, and 63.4% at 6 months. At 14 days, GOOSS scores increased by a median of 1 point. The overall GI adverse event rate was 32.4%; however, the stent-related adverse event rate was 19.4%. The median implant duration was 47 days (range 0-195 days)., Limitations: Observational study, no control group., Conclusions: Duodenal stent placement resulted in prompt relief of malignant gastric outlet obstruction and improved GOOSS scores. (, Clinical Trial Registration Number: NCT00991614.)., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration., Aims: To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction., Methods: Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated., Results: Overall median survival time was 190 days (30-856). Forty-four patients (62.8%) died after median 175.5 days (30-614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44-836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35-485) after treatment. Median survival after re-treatment was 66 days (13-597). Cholecystitis occurred in one patient (1.7%)., Conclusions: The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications., (Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy about endoscopic biliary stenting. The present Clinical Guideline describes short-term and long-term results of biliary stenting depending on indications and stent models; it makes recommendations on when, how, and with which stent to perform biliary drainage in most common clinical settings, including in patients with a potentially resectable malignant biliary obstruction and in those who require palliative drainage of common bile duct or hilar strictures. Treatment of benign conditions (strictures related to chronic pancreatitis, liver transplantation, or cholecystectomy, and leaks and failed biliary stone extraction) and management of complications (including stent revision) are also discussed. A two-page executive summary of evidence statements and recommendations is provided. A separate Technology Review describes the models of biliary stents available and the stenting techniques, including advanced techniques such as insertion of multiple plastic stents, drainage of hilar strictures, retrieval of migrated stents and combined stenting in malignant biliary and duodenal obstructions.The target readership for the Clinical Guideline mostly includes digestive endoscopists, gastroenterologists, oncologists, radiologists, internists, and surgeons while the Technology Review should be most useful to endoscopists who perform biliary drainage., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Duodenal stenting has become a broadly accepted first line of treatment for patients with advanced malignant gastroduodenal obstruction as these patients are difficult to treat and are poor surgical candidates., Aims: To document duodenal stent performance for palliative management of malignant gastroduodenal obstruction., Methods: Multicentre, single arm, prospective registry documenting peroral endoscopic duodenal stenting procedures in 202 patients., Results: Technical success achieved in 98% (CI, 95%, 99%) of stent placements. Increase of Gastric Outlet Obstruction Score by at least 1 point compared to baseline was achieved in 91% (CI, 86%, 95%) of patients persisting for a median of 184 days (CI, 109, 266). By day 5 (CI, 4, 6) after stent placement, 50% of patients experienced a score increase of at least 1 point. Improvement from 14% of patients at baseline tolerating soft solids or low residue/normal diet to 84% at 15 days, 86% at 30 days, 81% at 90 days, 79% at 180 days, and 70% at 270 days. Complications included stent ingrowth and/or overgrowth (12.4%), transient periprocedural symptoms (3%), bleeding (3%), stent migration (1.5%), and perforation (0.5%)., Conclusions: Safety and effectiveness of duodenal stenting for palliation of malignant gastroduodenal obstruction was confirmed in the largest international prospective series to date., (Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Biliary plastic stenting plays a key role in the endoscopic management of benign biliary diseases. Complications following surgery of the biliary tract and liver transplantation are amenable to endoscopic treatment by plastic stenting. Insertion of an increasing number of plastic stents is currently the method of choice to treat postoperative biliary strictures. Benign biliary strictures secondary to chronic pancreatitis or primary sclerosing cholangitis may benefit from plastic stenting in select cases. There is a role for plastic stent placement in nonoperative candidates with acute cholecystitis and in patients with irretrievable bile duct stones., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Biliary stenting is widely used to palliate malignant obstruction or to treat benign biliary diseases. Recently, the most important changes have related to self-expandable metal stents (SEMSs), which are now available in a wide variety of designs, and to treatment techniques. This article is part of a combined publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic biliary stenting: a technology review describes the stent models and stenting techniques, and a separate clinical guideline states the evidence and recommendations regarding stenting., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Study Aims: Covered self-expanding metal stents (SEMSs) have proven effective for managing malignant bile duct strictures and may reduce risk of tumor ingrowth. A new nitinol partially covered biliary SEMS was prospectively evaluated., Patients and Methods: 70 patients with inoperable extrahepatic biliary obstructions were enrolled in a prospective multicenter trial, and followed up to 6 months or death, whichever came first. Primary endpoint was adequate palliation defined as absence of recurrent biliary obstruction from partly covered SEMS placement to end of follow-up., Results: Mean age of the patients was 69 years and 52 % were men. Pancreatic carcinoma was present in 68 %. One stent was placed in 67 patients, two patients received two, and in one patient a guide wire could not traverse the stricture. In 55 % of patients the SEMS was inserted de novo and in 45 % for exchange with a plastic stent. Technical success was 97 %. At 6 months, 62 % of patients were free of obstructive symptoms; compared with baseline the mean number of symptoms per patient was significantly reduced (3.1 at baseline, 0.6 at 6 months; P < 0.0001) and total bilirubin levels dropped by 73 %. There were four cases of recurrent biliary obstruction, due to stent migration (2), tumor overgrowth (1), and sludge formation (1). Device-related complications included cholecystitis (3), right upper quadrant pain (1), and moderate pancreatitis (1). No tumor ingrowth was reported., Conclusions: This new partially covered nitinol SEMS is easily inserted, and safe and effective in the palliation of biliary obstruction secondary to malignant bile duct strictures., (© Georg Thieme Verlag KG Stuttgart · New York.)

Duodenal self-expandable metal stents (SEMS) are designed for palliation and prompt relief of malignant gastric outlet obstruction (GOO). This mini-invasive endoscopic treatment is preferable to surgery due to its lower morbidity and mortality, shorter hospitalization, and earlier symptoms relief; furthermore endoscopic enteral stenting can be performed under conscious sedation, reducing the risk of general anesthesia in these already fragile patients. The stent placement technique is well established and should be performed in referral centers with adequate materials and equipment. Duodenal stents can be covered and uncovered. Nitinol stents have almost replaced other materials, being more flexible with a satisfactory axial and radial force. Common duodenal SEMS-related complications are recurrence of GOO symptoms due to stent clogging (tissue ingrowth/overgrowth and food impaction) and stent migration. These complications can be usually managed endoscopically. Perforation and bleeding are the most severe, but rare, complications. After stent placement, malignant GOO patients usually have improvement of the GOO symptoms with good resumption of fluids and solids. Choosing the most appropriate type of stent is arduous and should be done mainly in relation to the morphological aspects of the stricture. Endoscopic duodenal SEMS placement is indicated in symptomatic GOO patients suffering from unresectable malignancy or those inoperable due to advanced age or comorbidities. The absence of peritoneal carcinomatosis and multiple small bowel strictures is a key point for the clinical success of duodenal SEMS. Almost all symptomatic malignant GOO patients are candidates for the duodenal SEMS procedure; resolution of GOO, avoiding the need for a permanent naso-gastric or percutaneous endoscopic gastrostomy tube, significantly improves the patients' quality of life and dignity, even if life expectancy is short. Endoscopic duodenal SEMS insertion, after an adequate training, is a reproducible, simple, safe, and cost-effective procedure.

Background: Endoscopic dilation of postoperative biliary strictures with increasing numbers of stents was first described by our group in 2001 with promising results after a long-term follow-up (mean 4 years)., Objective: To verify results of endoscopic treatment of postoperative biliary strictures at a very-long-term follow-up., Design: Single center, follow-up study., Setting: Tertiary-care, academic referral center., Patients: A group of 42 patients from our 2001 study, who had undergone endoscopic dilation of postoperative biliary strictures with the multiple endoscopic stenting technique, underwent systematic follow-up. The last telephone follow-up was done in September 2009., Intervention: Clinical conditions and the occurrence of new biliary symptoms during the follow-up period were assessed, and results of the most recent liver function tests and abdominal US were recovered., Main Outcome Measurements: Occurrence of cholangitis and liver function test evaluation during the follow-up period., Results: Of the 40 patients who were alive at the end of the study published in 2001, 5 (12.5%) died of unrelated causes after a mean of 6.7 years (range 3-13.3 years) from the end of treatment, without further biliary symptoms. The overall mean follow-up time for the remaining 35 patients (87.5%) was 13.7 years (range 11.7-19.8 years). Seven patients (20%) experienced recurrent acute cholangitis after a mean of 6.8 years (range 3.1-11.7 years) from the end of treatment. All 7 of these patients underwent ERCP. Four of the 7 patients had postoperative biliary stricture recurrence (n = 4/35, 11.4%) that was retreated endoscopically with placement of stents, and the other 3 patients had common bile duct stones (n = 3/35, 8.6%) that were extracted. No stricture or bile duct stone recurrences after retreatment were recorded after a mean follow-up period of a further 7.1 years (range 2.5-12.1 years). Twenty-eight patients remained asymptomatic with normal liver function test results and abdominal US results after a mean follow-up period of 13.7 years (range 11.7-19.8 years)., Limitations: Telephone follow-up., Conclusion: Results of multiple endoscopic stenting for postoperative biliary strictures remain excellent even after a very-long-term follow-up. The stricture recurrence rate is low, and recurrences can be retreated endoscopically., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy., Objective: To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement., Design: Prospective, multicenter cohort study., Setting: Four referral centers., Patients: The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients., Intervention: Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent., Main Outcome Measurements: Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent., Results: Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration)., Limitations: Small sample size, lack of a control group., Conclusion: Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use., (Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Emergency surgery for malignant colon obstruction entails relatively high morbidity and mortality rates and typically necessitates a 2-step resection. These problems might be potentially mitigated by placement of a self-expanding metal stent (SEMS) as a bridge to surgery. A nitinol colorectal SEMS may offer several advantages, but available evidence on the utility of this SEMS type remains highly limited., Objective: Our purpose was to evaluate the effectiveness and safety as a bridge to surgery of a nitinol SEMS designed for colorectal use., Design: Prospective and retrospective multicenter clinical study., Setting: Sixteen European study centers., Patients: Thirty-six patients with malignant colonic obstruction., Interventions: Nitinol colorectal SEMS placement., Main Outcome Measures: Technical success in accurate SEMS placement with coverage of the entire stricture length, clinical success in alleviating colonic obstructive symptoms, and bridging to elective surgery., Results: Technical success was achieved in 97% of patients with a 95% CI of 85% to 100% and clinical success in 81% (95% CI, 64%-92%). Elective surgery was performed in 94% (95% CI, 81%-99%) of patients at a median of 11 days (95% CI, 7-15 days) after SEMS placement. SEMS-related perforation occurred in 3 patients., Limitations: No control group was included in this nonrandomized cohort study., Conclusions: In this first comparatively large clinical study of a nitinol colorectal SEMS as a bridge to surgery, a high proportion of patients successfully proceeded to elective surgery after prior decompression by SEMS placement.

Background: Many patients who develop obstructive colonic symptoms secondary to inoperable colorectal cancer will require palliative treatment. A minimally invasive and potentially long-lasting approach is placement of nitinol self-expanding metal stents (SEMS)., Objective: To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction., Design: Prospective multicenter clinical study., Setting: Nine European study centers., Patients: Forty-four patients with malignant colonic obstruction., Interventions: Placement of nitinol SEMS designed for colorectal use., Main Outcome Measures: Technical success, defined as accurate SEMS deployment with adequate stricture coverage, and clinical success, defined as decompression and relief of obstructive colonic symptoms maintained without intervention or serious device-related complications., Results: Technical success was attained in 95% of patients, with 95% CI 85%-99%. After 6 months, the rate of clinical success was 81%, 95% CI 69%-96%. Survival at 6 months was 67%, 95% CI 54%-84%. Clinical success was maintained until death in 86% of the nonsurvivors. No perforations or SEMS-related deaths occurred., Limitation: This investigation was nonrandomized and did not include a control group., Conclusions: In a large prospective investigation, palliative placement of a nitinol SEMS designed for colorectal use was accomplished with a high rate of technical success. Durable clinical success was achieved in a high proportion of patients with low morbidity.

Background and Study Aims: Self-expandable metal stents (SEMS) are an effective palliative treatment for malignant biliary and duodenal strictures. Combined biliary and duodenal stenting remains a technical challenge, however. The aim of this study was to evaluate the technical feasibility of an endoscopic approach to double stenting of malignant biliary and duodenal strictures., Patients and Methods: Consecutive patients referred for palliative gastroduodenal and biliary stenting were followed up prospectively. Patients' demographic characteristics, the site and nature of the strictures, success rates, complications, and survival time were recorded., Results: A total of 64 patients underwent double stenting. In 46 patients, biliary obstruction occurred before the onset of duodenal obstruction (by a median of 107 days) (group 1); in 14 patients, biliary obstruction occurred concurrently with duodenal obstruction (group 2); and in four patients the duodenal obstruction preceded the biliary obstruction (by a median of 121 days) (group 3). The duodenal strictures were proximal to the papilla in 31 patients, adjacent to the papilla in 25 patients and distal to the papilla in eight patients. The majority of biliary strictures were in the middle or distal third of the bile duct (in 52/64 patients). Duodenal SEMS were successfully deployed in all patients. Combined endoscopic stenting was successful in 100% of patients in group 1, 86% of patients in group 2, and in 100% of patients in group 3. Taking the three groups together, early complications occurred in 6% of patients and late complications occurred in 16% of patients. The overall median survival after combined stenting was 81 days (range 2-447 days)., Conclusions: Combined endoscopic biliary and duodenal SEMS insertion is safe and effective for palliation in malignant biliary and duodenal obstruction. Biliary stenting through the mesh of the duodenal SEMS is technically feasible and has a high success rate.

The main therapeutic concern in patients with inoperable oesophageal cancer is palliation of dysphagia. Self-expandable metal stents are widely used because they are safer than conventional plastic stents, offer rapid relief from dysphagia and may seal off tracheo-oesophageal fistulae. Self-expanding metal stents, particularly when uncovered, are, however, associated with the disadvantage of tumour ingrowth. Self-expandable plastic stents are entirely covered and easy to reposition in case of migration and usually induce less inflammatory proliferation at their flanges when compared with metal stents. The major disadvantage of the current version of plastic stents is the large diameter and stiffness of the stent delivery system when compared with metal stents. Therefore, plastic stents are more difficult to place in patients with angulated strictures or with tumours located in the cervical oesophagus near the upper sphincter.

Background and Study Aims: Dominant pancreatic duct strictures located in the head of the pancreas in patients with severe chronic pancreatitis are often managed by endoscopic placement of a single plastic stent. Patients with refractory strictures after prolonged stenting require repeated stent replacement or surgical pancreaticojejunostomy. Placement of multiple plastic stents has proved effective in managing postoperative biliary strictures. The aim of this study was to investigate the feasibility, efficacy, and long-term results of multiple stenting of refractory pancreatic strictures in severe chronic pancreatitis., Patients and Methods: 19 patients with severe chronic pancreatitis (16 men, three women; mean age 45 years) and with a single pancreatic stent through a refractory dominant stricture in the pancreatic head underwent the following protocol: (i) removal of the single pancreatic stent; (ii) balloon dilation of the stricture; (iii) insertion of the maximum number of stents allowed by the stricture tightness and the pancreatic duct diameter; and (iv) removal of stents after 6 to 12 months., Results: The median number of stents placed through the major or minor papilla was 3, with diameters ranging from 8.5 to 11.5 Fr and length from 4 to 7 cm. Only one patient (5.5 %) had persistent stricture after multiple stenting. During a mean follow-up of 38 months after removal, 84 % of patients were asymptomatic, and 10.5 % had symptomatic stricture recurrence. No major complications were recorded., Conclusion: Endoscopic multiple stenting of dominant pancreatic duct strictures in chronic pancreatitis is a feasible and safe technique. Multiple pancreatic stenting is promising in obtaining persistent stricture dilation on long-term follow-up in the setting of severe chronic pancreatitis.

Background: Endoscopic removal of malfunctioning self-expandable metallic biliary stents (SEMS) is difficult and not well described. The aim of this study is to review the indications, the techniques, and the results of SEMS removal in a cohort of patients with malfunctioning stents., Methods: All patients who underwent an attempt at endoscopic removal of biliary SEMS over a 5-year period were retrospectively identified. The main indications for SEMS removal were the following: distal migration of the stent or impaction to the duodenum, impaction into the bile-duct wall, tissue ingrowth, and inappropriate length of the stent causing occlusion of intrahepatic ducts. SEMS were removed by using foreign-body forceps or polypectomy snares., Results: Endoscopic removal of 39 SEMS (13 uncovered and 26 covered) was attempted in 29 patients (17 men; mean age, 66 years). SEMS extraction was attempted after a mean of 7.5 months (8.75 months standard deviation) post-SEMS insertion. Removal was successful in 20 patients (68.9%) and in 29 SEMS (74.3%). Covered SEMS were effectively removed more frequently than uncovered ones: 24 of 26 (92.3%) and 5 of 13 (38.4%), respectively (p < 0.05). No major complications were recorded. Multivariate analysis showed that the time interval between insertion and removal, SEMS length, stent-mesh design (zigzag vs. interlaced), and indication for removal were not predictive of success at stent removal., Conclusions: Endoscopic removal of biliary SEMS is feasible and safe in more than 70% of cases. Because only 38% of uncovered SEMS were removable, the presence of a stent covering is the only factor predictive of successful stent extraction. The presence of diffuse and severe ingrowth was the main feature limiting SEMS removal.

Background: Endoscopic placement of self-expandable metallic stents for palliation of patients with malignant gastric outlet obstruction is safe and feasible., Methods: Patients with malignant gastric outlet obstruction undergoing enteral stent insertion were identified from endoscopy databases. Duration of oral intake after stent insertion was calculated by using the log-rank test. Factors associated with duration of oral intake were assessed by using Cox multivariable regression analysis., Results: A total of 176 patients (mean age 65 [14] years) treated at 4 centers from 1996 to 2003 were identified. Obstruction was caused by cancer of the pancreas in 84, the stomach in 20, the bile duct in 15, the major duodenal papilla in 8, another primary site in 16, and metastases in 33. The site of obstruction was the duodenum in 125, the distal stomach in 17, the stomach and the duodenum in 18, and surgical anastomosis in 16 patients. Stent deployment was technically successful in 173. Complications occurred in 14 patients. Seventeen patients were lost to follow-up. Of the remaining 159 patients, 133 resumed oral intake for a median time of 146 days: 95% CI [65, 202]. On regression analysis, chemotherapy after stent placement was associated with prolonged duration of oral intake (hazard ratio 0.41: 95% CI [0.23, 0.72])., Conclusions: After enteral stent insertion for malignant gastric outlet obstruction, 84% of patients resumed oral intake for a median time of 146 days. Chemotherapy after enteral stent insertion was independently associated with prolongation of oral intake.

Pain is a major issue of palliative treatment in many patients with advanced pancreatic cancer. 'Obstructive'-type pain identified by correlation with meals, back radiation and dilation of main pancreatic duct upstream the stricture may be treated by endoscopic stent placement into the pancreatic duct in order to by-pass the stricture. The clinical experience reported in the literature shows that pancreatic plastic stenting for 'obstructive' pain may provide complete relief of pain in about 60% of patients and partial relief in 25%.

Tumours that involve the confluence of the bile ducts in the liver hilum provide a major therapeutic challenge. Adequate palliation requires relief of jaundice. Even though jaundice can be relieved if only 30% of the liver is drained, the presence of undrained bile ducts may result in pruritus and a continued risk of cholangitis and hepatic abscess. The biliary anatomy is defined by cholangiography, which today can be performed by magnetic resonance; the stricture is dilated, and plastic or metallic stents are endoscopically inserted over a guidewire. Patients with complex hilar strictures may benefit from the insertion of one or more stents, although there is debate about how many are necessary. The present article provides specific technical details, describes comparative trials of unilateral versus bilateral biliary drainage and explores new techniques that warrant further investigation.

Endoscopic treatment of pancreatobiliary malignancies has been recognized in the last decades as the treatment of choice in inoperable patients. Endoscopic armamentarium includes biliary stents (plastic and metallic) to bypass neoplastic strictures of the biliary tree, and pancreatic stents to palliate the obstructive pain caused by stenoses of the main pancreatic duct. A major issue is the long-term patency of plastic stents that will eventually clog on average after 3 to 4 months. Self-expandable metallic stents have longer patency, but they can also become occluded by tumor ingrowth or overgrowth; they are also much more expensive; their use is thus recommended in patients with longer life expectancy. Decompression of the dilated main pancreatic duct in pancreatic carcinoma may be effective in the relief of obstructive pain. Endoscopic palliation in pancreatic and biliary malignancies appears safe and effective; management of patient in referral centers, with an available team of gastroenterologists with endoscopic skills, surgeons, and radiologists is recommended.

Background and Study Aims: Endoscopic biliary stenting is an established treatment for malignant obstructive jaundice. Stent clogging continues to be a major problem with plastic stents. The aim of this study was to carry out a prospective comparison of two stents with different materials and shapes: the Olympus DoubleLayer stent (DLS; perfluoro alkoxy, without sideholes) and the standard polyethylene (PE) stent (with sideholes)., Patients and Methods: A total of 120 patients (70 women; mean age 71, range 36 - 91) with jaundice due to malignant strictures of the middle to distal third of the common bile duct were randomly assigned to receive either DLS (n = 60) or PE (n = 60) biliary stents. Patients with cholangitis, hemobilia, previous biliary drainage, hilar stricture, or ampullary cancer were excluded., Results: In all, 28 DLS patients (47 %) and 17 PE stent patients (29 %) died without clinical evidence of stent occlusion after a mean of 114 and 105 days, respectively ( P < 0.05). Twenty-six DLS patients (43 %) and 38 PE stent patients (63 %) had symptoms of stent clogging after a mean of 144 and 99 days, respectively ( P < 0.05). Stent dysfunction (stent orifice impacted on the bile duct or duodenal wall, stent migration) was recorded in six DLS patients (10 %) and five PE patients (8 %) (n. s.). Kaplan-Meier analysis of DLS and PE stent clogging-free survival showed a significantly longer patency period with the DLS stents (P = 0.0005)., Conclusions: These results show that DoubleLayer stents have a longer patency period than PE stents. Patients who received PE stents had a higher risk of stent occlusion (relative risk 3.05; 95 % CI, 1.57 - 5.89) before death than DLS patients.