Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomised controlled trial.

OBJECTIVE: Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12-13 cm. Shorter cuts could have the advantage of shorter procedure time and possibly reduced gastro-oesophageal reflux disease (GORD) rate. DESIGN: This single-centre, patient-blinded, randomised, non-inferiority clinical trial included 200 patients, who were randomly allocated, to receive either a long-POEM (13 cm; 101 patients) or a short-POEM (8 cm; 99 patients). Primary outcome was defined as an Eckardt symptom score of ≤3 at 24 months after the procedure; a non-inferiority design was chosen with an accepted success range of 6% between the two treatments. Secondary outcomes included operating time, complication rate, postoperative manometry, GORD rate and quality of life. RESULTS: In the intention-to-treat analysis, clinical success rates were 89.1% in the long-POEM and 98.0% in the short-POEM group, resulting in an absolute between-group difference of -8.9% (90% CI -14.5 to -3.3).Procedure time was significantly reduced in the short-POEM as compared with the long-POEM group (40 vs 50 min, p<0.0001). Severe adverse events occurred in one patient in both groups.No differences were observed in postoperative GORD: acid exposure >6% on pH monitoring study at 6 months was seen in 34.3% (long-POEM) vs 31.1% (short-POEM), while endoscopic oesophagitis was diagnosed in 37.6% vs 51.5% at 6 months and in 21% vs 24.5% at 24 months. Regular proton pump inhibitor use was not different either (36.8% vs 37.5%). CONCLUSIONS: Our study demonstrates non-inferiority of a shorter cut length of POEM as compared with the standard treatment, which saved some procedural time. GORD rate was not reduced by reducing cutting length. TRIAL REGISTRATION NUMBER: NCT03450928.

Fibrin glue injection: Rescue treatment for refractory post-sphincterotomy and post-papillectomy bleedings.

OBJECTIVES: Endoscopic sphincterotomy (ES) and papillectomy (EP) are associated with a non-negligible risk of post-procedural bleeding. Despite first-line endoscopic hemostasis being achieved by several methods, patients may experience bleeding persistence or recurrence. In such cases, fibrin glue (FG) injection may be used as a rescue therapy before more invasive approaches. The aim of this study was to evaluate the efficacy and safety of endoscopic FG injection to treat refractory post-ES and post-EP bleeding. METHODS: Data were collected retrospectively from patients with refractory immediate or delayed bleeding following ES or EP, between October 2007 and November 2019, at a single institution. Clinical success was defined as bleeding control after FG injection. RESULTS: Overall, 70 patients were included. Clinical success was reached in 64 (91.4%) patients after one session of FG injection. Of six (8.6%) patients in whom the treatment failed, one required subsequent insertion of a fully covered self-expanding metal stent (FC-SEMS) due to immediate massive bleeding, while five experienced bleeding recurrence. Such events were managed with an additional session of FG injection that failed in two cases. Therefore, one patient underwent FC-SEMS plus selective embolization, whereas the other underwent diagnostic arteriography. No severe periprocedural complications occurred. Two cases of intrabiliary glue migration were treated by endoscopic removal with a retrieval basket. CONCLUSIONS: Rescue therapy with endoscopic FG injection appears to be effective and safe to treat refractory post-ES and post-EP bleeding. Further studies are required to confirm these preliminary data.

Endoscopic management of non-anastomotic biliary strictures following liver transplantation: Long-term results from a single-center experience.

OBJECTIVES: Studies on endoscopic treatment of non-anastomotic biliary strictures (NABS) following orthotopic liver transplantation (OLT) are scanty and with a short follow-up. The long-term results of endoscopic treatment with plastic stents of NABS following OLT were analyzed. METHODS: Retrospective analysis of consecutive enrolled patients who underwent endoscopic treatment for NABS after OLT between 1997 and 2015. Endoscopic treatment success was defined as stricture resolution, without recurrence. RESULTS: During the study period, 33 patients with NABS underwent endoscopic retrograde cholangiopancreatography (ERCP) in our center. A total of 68 ERCP were performed with a 4.4% of procedure-related adverse events. Mortality related to cholangitis secondary to endoscopic procedures was 12%. After median follow-up of 70.3 months from stents removal, NABS resolution was obtained in 12 out of 24 (50%) patients. Only one case of late NABS recurrence was observed which was successfully retreated endoscopically. According to our data analysis NABS occurring <12 months from OLT showed a worse prognosis (P < 0.04). CONCLUSIONS: The follow-up of this study confirms that endoscopic treatment of NABS is unsatisfactory. However, patients who respond to endoscopic treatment maintain the response over time. Prompt treatment of acute cholangitis due to stents occlusion is advised in these patients to avoid high mortality rates.

Endotherapy of postcholecystectomy biliary strictures with multiple plastic stents: long-term results in a large cohort of patients.

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.

Long-term outcomes of endoscopic treatment of aberrant hepatic duct injuries after cholecystectomy.

BACKGROUND AND AIMS: Right aberrant hepatic ducts are an anatomic variant with clinical relevance because of the risk of injury during cholecystectomy. Treatment options for aberrant hepatic duct injuries are not standardized. This study aims to analyze the long-term results of endoscopic treatment of aberrant hepatic duct lesions. METHODS: Patients who underwent ERCP for aberrant hepatic duct lesions were retrospectively identified. Demographic data, type of aberrant duct lesion according to the Strasberg classification, type of treatment (number of plastic stents inserted, treatment duration, and number of ERCPs), and adverse events were recorded. Follow-up was obtained by telephone contact or medical examinations. RESULTS: Between January 1996 and March 2019, 32 patients (78% women, mean age 51.7 years) with aberrant hepatic duct injuries underwent ERCP at our Endoscopy Unit. Six patients had Strasberg type B lesions, 11 patients had type C, and 8 patients had type E5, and 7 patients had a stenosis of the aberrant duct. A mean of 3.7 biliary plastic stents per patient were used; mean treatment duration was 6.3 months. All patients with isolated aberrant duct stenosis and 1 of 6 patients (17%) with type B Strasberg lesions achieved patency. Ten of 11 patients (91%) with type C Strasberg lesions achieved duct recanalization. After a mean follow-up of 109.3 ± 61.2 months, 29 of 32 patients (91%) were asymptomatic; 1 underwent surgery for recurrent cholangitis, 1 received a new endoscopic procedure because of cholangitis, and 1 reported episodic biliary colic without an increase in liver function test values and was successfully managed with a low-fat diet. CONCLUSIONS: An endoscopic approach to aberrant hepatic duct lesions after cholecystectomy can be considered an effective first-line therapy.

Endoscopic Management of Benign Biliary Strictures After Liver Transplantation.

Biliary strictures represent some of the most frequent complications encountered after orthotopic liver transplantation. They comprise an array of biliary abnormalities with variations in anatomical location, clinical presentation, and different pathogenesis. Magnetic resonance cholangiography represents the most accurate noninvasive imaging test that can provide detailed imaging of the whole biliary system-below and above the anastomosis. It is of particular value in those harboring complex hilar or intrahepatic strictures, offering a detailed roadmap for planning therapeutic procedures. Endoscopic therapy of biliary strictures usually requires biliary sphincterotomy plus balloon dilation and stent placement. However, endoscopic management of nonanastomotic biliary strictures is much more complex and challenging as compared with anastomotic biliary strictures. The present article is a narrative review presenting the results of endoscopic treatment of biliary strictures occurring after liver transplantation, describing the different strategies based on the nature of the stricture and summarizing their outcomes.

Long-term follow-up after multiple plastic stenting for refractory pancreatic duct strictures in chronic pancreatitis.

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.

Right hepatic artery syndrome: report of three cases and literature review.

Anatomical variations of the hepatic artery have been described as responsible for the onset of jaundice or stone formation. We present three cases of intrahepatic stones secondary to a compression of the proximal common bile duct (CBD) by the right hepatic artery (RHA). Three consecutive patients (males, mean age 65 years) with symptoms of cholangitis and intra-hepatic stones admitted between October 2017 and June 2018 with a final diagnosis of CBD compression from the RHA. The three patients underwent ERCP and biliary sphincterotomy with extraction of intra-hepatic stones; after stone removal cholangiograhy showed CBD compression just below the main hepatic confluence which was confirmed to be secondary to RHA compression on subsequent MRI. The patients remained asymptomatic after 12 months mean follow-up. Compression of the CBD by the RHA might be responsible for intra-hepatic stone formation. Endoscopic treatment is feasible and effective on short-term follow-up.

Pancreas divisum and recurrent pancreatitis: long-term results of minor papilla sphincterotomy.

Background and aims: Pancreas divisum (PD) is the most common congenital variant of the pancreatic ductal system and a potential cause of acute recurrent pancreatitis (ARP). Endoscopic therapy is a therapeutic option for symptomatic PD, but there is limited data on long-term results. We aimed to assess the effect of minor papilla endoscopic sphincterotomy (MiES) in the setting of ARP in patients with PD. Methods: Consecutive patients treated by MiES were included. Clinical data, including gender, age, smoking and drinking habits, number of episodes of acute pancreatitis (AP) as well as technical data pertaining to the endoscopic therapy were reviewed. Patients available for follow-up were contacted to assess the long-term impact of MiES using the Patient's Global Impression of Change (PGIC) questionnaire. Results: A total of 138 patients with PD including 77 patients with ARP underwent MiES; 48 patients were available for long-term follow-up using the PGIC score, with a mean follow-up period of 9.7 years. Procedure-related adverse events developed in 10 cases (12.9%): 5 post-MiES delayed bleeding and 5 mild pancreatitis. MiES was clinically successful in 35 patients (72.9%) who did not experience any more episodes of AP. Improvement in quality of life (PGIC ≥6) occurred in 41/48 patients (85.4%). On multivariate analysis, stenosis of the MiES was the only predictive factor for increased risk of recurrent pancreatitis after initial therapy. Conclusion: MiES resulted an efficient treatment for ARP in patients with PD with clinical benefit, patient satisfaction and improved quality of life even at long-term follow-up.

Endoscopic mucosal resection of non-ampullary sporadic duodenal adenomas: a retrospective analysis with long-term follow-up.

OBJECTIVE: We investigate the efficiency of endoscopic mucosal resection (EMR) of non-ampullary sporadic duodenal adenomas (NASDA) in a retrospective analysis with long-term follow-up. METHODS: Consecutive patients undergoing EMR of NASDA between May 2002 and December 2016 were retrospectively identified from an electronic database. Endoscopic follow-up was scheduled after 3, 6 and 12 months for the first year, then yearly for up to five years. RESULTS: EMR of 75 NASDA was performed in 68 patients (56% en-bloc, 44% piecemeal). Retroperitoneal perforations occurred in 3/68 (4.4%) patients, were treated by surgical (n = 2) or percutaneous (n = 1) drainage; delayed bleeding was reported in 13/75 (17.3%) resections and was successfully managed by endoscopy (n = 12) or radiologic embolization (n = 1). There was no procedure-related mortality. Follow-up was available in 61/68 patients (89.7%) after a median time of 59 months from resection. Residual and recurrent adenoma were diagnosed in 9 (14.5%) and 6 (10.9%) cases, respectively; all but one were successfully retreated endoscopically. CONCLUSIONS: EMR for NASDA is effective with a favorable long-term outcome. Local recurrences can be retreated endoscopically. A recall system, patient's compliance to endoscopic follow-up are mandatory to detect recurrences and their prompt treatment.

Endoscopic treatment of post-laparoscopic sleeve gastrectomy leaks using a specifically designed metal stent.

Background and study aim Leakage of the surgical suture is the main complication of laparoscopic sleeve gastrectomy (LSG) and is amenable to endoscopic therapy. The aim of this study was to evaluate the efficacy of a specifically designed self-expandable metal stent (SEMS) to seal the leakage. Patients and methods Over a 2-year period, patients referred for the treatment of post-LSG fistulas underwent placement of a fully covered esophagogastric SEMS with a specific design. Results A total of 10 patients were treated after a mean time of 50.9 days from the diagnosis of post-LSG leakage. A total of 11 SEMSs were placed. After stent removal, the leakage was seen to have healed in eight patients. Two patients who were treated with an SEMS with different mesh design, experienced stent migration, which required alternative endoscopic treatment such as the insertion of double-pigtail stents. After a mean follow-up period of 13.4 months, all patients were asymptomatic. Conclusions: Placement of a specifically designed SEMS for the treatment of post-LSG fistulas seems a promising first-line therapy according to this small series.

Peroral Endoscopic Myotomy for Esophageal Achalasia: Outcomes of the First 100 Patients With Short-term Follow-up.

OBJECTIVE: Aim of this study is to report the mid-term outcomes of a large series of patients treated with peroral endoscopic myotomy (POEM) in a single European center. BACKGROUND: POEM is a recently developed treatment of achalasia, which combines the efficacy of surgical myotomy, with the benefits of an endoscopic procedure. Previous studies, including few patients with a short-term follow-up, showed excellent results on dysphagia relief. METHODS: The first 100 adult patients treated in a single tertiary referral center were retrospectively identified and included in this study (41 men, mean age 48.4 years). Patients were treated according to a standard technique. Follow-up data, including clinical evaluation, and results of esophagogastroduodenoscopy (EGD), manometry, and pH monitoring were collected and analyzed. RESULTS: POEM was completed in 94% of patients. Mean operative time was 83 minutes (49-140  minutes). No complications occurred. Patients were fed after a median of 2 days (1-4 days). A mean follow-up of 11 months (3-24 months) was available for 92 patients. Clinical success was documented in 94.5% of patients. Twenty-four-hour pH monitoring documented Gastro-Esophageal Reflux Disease (GERD) in 53.4% of patients. However, only a minority of patients had heartburn (24.3%) or esophagitis (27.4%), and these patients were successfully treated with proton-pump inhibitors. CONCLUSIONS: Our results confirm the efficacy of POEM in a large series of patients, with a mean follow-up of 11 months. Should our results be confirmed by long-term follow-up studies, POEM may become one of the first-line therapies of achalasia in the next future.

Prognostic variables for the clinical success of flexible endoscopic septotomy of Zenker's diverticulum.

BACKGROUND AND AIMS: Flexible endoscopy septotomy for Zenker's diverticulum (ZD) is an alternative to endostapling; however, long-term data are sparse and studies are heterogeneous. The aim of this study was to assess the clinical success of flexible endoscopy diverticuloscope-assisted septotomy according to all ZD-related symptoms and to identify potential prognostic variables. METHODS: A prospective database of all patients with ZD undergoing septotomy and followed up for 24 months or longer was analyzed. Septotomy was conducted by using a diverticuloscope-assisted technique. Dysphagia, regurgitation, and respiratory symptoms (during the day and at night) were scored by their weekly frequency from 0 to 3 when on a solid food diet. Clinical success (asymptomatic state) was defined as a maximum of 2 symptoms with a score of 1 (once per week). Prognostic variables of clinical success included age, sex, pretreatment total symptom score, pre- and posttreatment ZD size, and septotomy length. The Kaplan-Meier method and Cox proportional hazards model were used to calculate the crude and adjusted hazard ratio (HR). RESULTS: Septotomy was attempted and achieved in a single session in 89 patients. Clinical success at the intention-to-treat analysis was 69%, 64%, and 46% at 6, 24, and 48 months, respectively. Adverse events occurred in 3 patients: perforation in 2 (2%) and postprocedural bleeding in 1 (1%). Independent variables for failure at 6 months were a septotomy length ≤25 mm (HR 6.34) and pretreatment ZD size ≥50 mm (HR 11.08), whereas at 48 months, they were septotomy length ≤25 (HR 2.20) and posttreatment ZD size ≥10 mm (HR 2.03). Success rates for ZD ranging in size from 30 mm to 49 mm with a septotomy >25 mm were 100% and 71% at 6 months and 48 months, respectively. CONCLUSION: Flexible endoscopic septotomy for ZD is feasible and safe. Treatment success correlates with the length of the septotomy and the size of ZD, which should ultimately determine the appropriate approach.

Endoscopic management with multiple plastic stents of anastomotic biliary stricture following liver transplantation: long-term results.

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.

Gastroesophageal reflux disease after peroral endoscopic myotomy: Analysis of clinical, procedural and functional factors, associated with gastroesophageal reflux disease and esophagitis.

BACKGROUND AND AIM: Peroral endoscopic myotomy (POEM) does not include any antireflux procedure, resulting in a certain risk of iatrogenic gastroesophageal reflux disease (GERD). The aim of the present study was to evaluate the incidence of iatrogenic GERD after POEM and identify preoperative, perioperative and postoperative factors associated with GERD. METHODS: All patients treated at a single center who had a complete GERD evaluation after POEM were included in the study. Demographics, preoperative and follow-up data, results of functional studies and procedural data were collected and analyzed. RESULTS: A total of 103 patients (mean age 46.6 years, 47 males) were included. Postoperative altered esophageal acid exposure was attested in 52 patients (50.5%). A total of 19 patients (18.4%) had heartburn and 21 had esophagitis (20.4%). Overall, a clinically relevant GERD (altered esophageal acid exposure, associated with heartburn and/or esophagitis) was diagnosed in 30 patients (29.1%). Correlation between the severity of esophageal acid exposure with heartburn and esophagitis after POEM was found. Patients with heartburn had a lower postoperative 4-second integrated relaxation pressure compared to patients without symptoms (7.6 ± 3.8 mmHg vs 10.01 ± 4.4 mmHg, p<0.05). No correlations were identified with patient sex, age, postoperative body mass index, esophageal shape (sigmoid vs non sigmoid), lower esophageal sphincter pressure, length of myotomy, previous therapies and type of achalasia at high-resolution manometry. CONCLUSIONS: Preoperative, perioperative or postoperative factors minimally correlated with GERD after POEM. Clinically relevant GERD was identified in less than one-third of patients, but all patients were well controlled with medical therapy.

ERCP in patients with prior Billroth II gastrectomy: report of 30 years' experience.

BACKGROUND AND STUDY AIM: Endoscopic retrograde cholangiopancreatography (ERCP) is difficult in patients with altered anatomy following Billroth II gastrectomy. Afferent loop intubation, selective cannulation, and sphincterotomy are the main issues. Experience from a tertiary referral endoscopy center is reported. PATIENTS AND METHODS: A total of 713 patients with Billroth II reconstruction who underwent ERCP between October 1982 and October 2012 were retrospectively identified from a prospectively collected database (mean age 69 ±â€Š27 years; 567 males). The main indications for ERCP were common bile duct stones (51.2 %) and obstructive jaundice (24.8 %). Procedures were always started with a duodenoscope; in cases of failure to reach the papilla the duodenoscope was changed to a gastroscope. Endoscopic sphincterotomy was performed using a long-nose sigmoid inverted sphincterotome. RESULTS: The successful duodenal intubation rate was 86.7 % (618/713 patients). The main reason for intubation failure was a long and angulated afferent loop. Successful cannulation/opacification of the desired biliopancreatic duct was 93.8 % (580/618). Biliary and/or pancreatic sphincterotomy were performed in 490 (84.5 %) and 23 (4.0 %) patients, respectively. The adverse event rate was 4.3 % (45/1050 procedures). Peritoneal perforation occurred in 1.8 % of the cases (19/1050 procedures) and always required immediate surgery. Two patients died after surgery (overall mortality 0.3 %). The other adverse events resolved following conservative management or endoscopic reintervention. CONCLUSIONS: In experienced centers, ERCP in Billroth II patients had morbidity and mortality rates that were comparable to patients with normal anatomy. The main reasons for failure were related to the inability to reach the papilla. Peritoneal perforation was the most common adverse event, and required a prompt surgical approach.

Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study.

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.).