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Background and Aims: Bilomas most frequently result from postoperative bile leaks. The endoscopic conventional treatment is sphincterotomy ± stent placement. In complex cases, such as altered anatomy or failure of conventional treatment, transpapillary/transfistulary (TP/TF) drainage or EUS-guided transmural drainage (EUS-TD) may obviate additional biliary surgery. This study reports our experience with treating biloma secondary to refractory biliary leak with TP/TF drainage or EUS-TD and evaluates the safety and outcomes associated with this approach., Methods: This observational study focused on consecutive patients managed for biliary leakage (diagnosis based on imaging and/or bile outflow from a surgical drain) at a tertiary care hospital (2007-2017). TP/TF drainage was performed by double-pigtail stent(s) placement to drain the biloma through the leak during ERCP. For EUS-TD, plastic stent(s) were placed under EUS control. Primary outcomes were a composite of clinical success (patient free of sepsis after percutaneous drain removal and, in patients with benign disease, removal of all endoscopically placed stents, without need for reintervention) and biloma regression (<3 cm) at last follow-up., Results: Thirty patients (men, 57%; median age, 55 years) were included. Most biliary leaks resulted from cholecystectomy (27%) and hepatectomy (50%). Initial EUS-TD and TP/TF drainage were performed in 14 (47%) and 16 (53%) patients, respectively. At last follow-up (median, 33.2 months), clinical success and primary outcome were achieved in 70.4% of patients (EUS-TD, 75%; TP/TF, 67%). Additional surgery was necessary in 1 patient. Rate of serious adverse events was 23% (7/30), of which 13% (4/30) were procedure related. There were 4 deaths during the course of treatment, 2 of which were related to endoscopic interventions (hemorrhage and fibrillation)., Conclusions: TP/TF drainage or EUS-TD is technically feasible with high clinical success and may avoid the need for additional surgery in complex cases or in patients with altered anatomy., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Diverticulotomy is a standard treatment for Zenker's diverticulum (ZD). This technique was adapted to flexible endoscopy., Objective: We report our long-term results of ZD treatment by using flexible endoscopy assisted by a soft diverticuloscope., Design: Follow-up study., Setting: Academic hospital. Tertiary-care referral center., Patients: A total of 150 patients with ZD were treated with the same technique from July 2002 to June 2011., Intervention: The procedure was performed by using a soft diverticuloscope to expose the septum, which was then cut with a needle-knife, and the procedure was completed by use of endoclip placement at the bottom of the section., Main Outcome Measurements: Symptoms were compared before and after the procedure, 1 month later, and at the end of follow-up., Results: The median size of the ZD was 3 cm (range 1-8 cm). The endoscopic incision was performed in one session (range 1-3 sessions). Clinical success at 1 month was 90.3%. Four adverse events (2.2%) occurred and were managed conservatively. Symptom evaluation at 1 month and at the end of follow-up was obtained in 103 and 134 patients, respectively. The dysphagia score dropped from 1.88 to 0.29 (P < .01) and 0.34 (P < .05) at 1 month and at the end of follow-up, respectively (median 43 months, range 13-121 months). Regurgitations and chronic cough dropped from 73% and 27% to 11% and 2% at the end of follow-up, respectively. Symptom recurrence occurred in 31 patients (23.1%); among them 23 had a second treatment, and only 5 required a third one., Limitations: Retrospective study, single center., Conclusion: Endoscopic incision of ZD by using a soft diverticuloscope and completed by endoclips is safe and efficient at short term and long term., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate., Objective: To evaluate the safety and efficacy of TOGA at 12-month follow-up., Design: Prospective, multicenter, single-arm trial., Setting: Two tertiary-care referral medical centers., Patients: This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40)., Intervention: The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals., Main Outcome Measurements: Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use., Results: Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively., Limitations: Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up., Conclusion: The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Self-expandable metal stents (SEMSs) have been suggested for the treatment of benign upper GI leaks and perforations. Nevertheless, uncomplicated removal remains difficult. Placement of a self-expandable plastic stent (SEPS) into an SEMS can facilitate retrieval., Objectives: This study reviews our experience with sequential SEMS/SEPS placement in patients with benign upper GI leaks or perforations., Design: A retrospective review of the chart of each patient who underwent SEMS placement for benign upper GI leaks or perforations, including (1) fistula after bariatric surgery, (2) other postoperative fistulae, (3) Boerhaave syndrome, (4) iatrogenic perforations, and (5) other perforations., Setting: Single, tertiary center., Patients: Eighty-eight patients (37 male, average age 51.6 years, range 18-89 years)., Interventions: SEMS placement and removal, with or without SEPS placement., Main Outcome Measurements: Feasibility of SEMS removal and successful treatment of lesions and short-term and long-term complications., Results: A total of 153 SEMSs were placed in 88 patients; all placements were successful. Six patients died (not SEMS-related deaths) and 6 patients were lost to follow-up with SEMSs still in place. Seventy-three of the remaining 76 patients had successful SEMS removal (96.1%). The rate of successful SEMS removal per stent was 97.8% (132/135). Resolution of leaks and perforations was achieved in 59 patients (77.6%) with standard endoscopic treatment, and in 64 patients (84.2%) after prolonged, repeated endoscopic treatment. Spontaneous migration occurred in 11.1% of stents, and there were minor complications (dysphagia, hyperplasia, rupture of coating) in 20.9% and major complications (bleeding, perforation, tracheal compression) in 5.9%., Limitations: Retrospective design and highly selected patient population., Conclusions: Use of SEMSs for the treatment of benign upper GI leaks and perforations is feasible, relatively safe, and effective, and SEMSs can be easily removed 1 to 3 weeks after SEPS insertion. Leaks and perforations were closed in 77.6% of cases., (Copyright © 2011 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: Intragastric band migrations or dysfunctions are common long-term complications of both vertical banded gastroplasty (VBG) and laparoscopic adjustable gastric banding (Lap-Band) that classically require surgical treatment., Objective: In this series, we describe the endoscopic removal of partially eroded Lap-Bands or Silastic rings and noneroded dysfunctioning rings after VBG., Design: Case series., Setting: A European, tertiary-care academic center., Patients: This study involved 13 patients--3 with eroded Lap-Bands, 4 with eroded Silastic rings, and 6 with refractory outlet stoma stenosis after VBG., Intervention: Endoscopic removal was performed within 1 or 2 sessions, according to the presence and extent of band erosion at presentation, including optional placement of a self-expandable plastic stent across the band, followed about 6 to 8 weeks later by extraction with transsection, if needed, by using a wire-cutting system., Main Outcome Measurements: Technical success and safety., Results: One failure was caused by huge adhesion formation around a Lap-Band on the lesser curvature of the stomach and the left liver lobe. Twelve of 13 endoscopic removals were successful in 1 (n = 2) and 2 (n = 10) sessions., Limitations: Highly selected patients (tertiary-case academic center)., Conclusion: Endoscopic removal of dysfunctioning bands or rings is safe and feasible by the use of a 1- or 2-step endoscopic procedure., (2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Duodenal duplication cysts are rare congenital anomalies. Symptomatic cases have classically been treated by surgical resection, which can be complex because of the close proximity of the cysts to the papilla., Objective: To describe a series of 8 patients with symptomatic duodenal duplication cysts who were treated endoscopically, with a special focus on the long-term outcome., Design: Retrospective case series., Setting: Three tertiary-care European academic hospitals., Patients: Eight patients, age 8 to 72 years, were treated endoscopically for symptomatic intraluminal duodenal duplication cysts between 1981 and 2006. Seven patients presented with acute pancreatitis, and one patient presented with jaundice., Intervention: Endoscopic incision and marsupialization of the cysts was performed by using a variety of endoscopic tools (needle-knife and regular sphincterotomes, cystotomes, and polypectomy snares)., Main Outcome Measurements: Technical success of endoscopic intervention and long-term clinical recurrence of symptoms., Results: No major complications occurred. All patients remained asymptomatic at a median follow-up of 7.3 years., Limitations: Retrospective study; the small number of patients., Conclusions: The endoscopic treatment of symptomatic intraluminal duodenal duplication cysts is a safe and effective technique, with excellent long-term results. It represents a minimally invasive alternative to surgical resection and might be considered the preferred therapeutic modality for these cases.

Background: Transmural endoscopic drainage has become the treatment of first choice for uncomplicated pseudocysts. Drainage is mostly performed with presently available therapeutic oblique-viewing (45 degrees ) US endoscopes. Puncturing at an angle sometimes hampers successful completion of the procedure, because the force that is applied while introducing instruments through the working channel is not fully exerted at the tip of the accessory but instead drives the endoscope away from the gut wall. A prototype forward-viewing US endoscope was developed to overcome this difficulty., Objective: Evaluation of an initial experience with a novel prototype forward-viewing US endoscope in endoscopic drainage of pancreatic pseudocysts., Design: Retrospective, observational study., Setting: Two tertiary-referral centers., Patients: Seven patients were treated., Interventions: Endoscopic drainage of pancreatic pseudocyst with a novel forward-viewing US endoscope., Main Outcome Measurements: Successful endoscopic drainage., Observations: In all cases drainage was successfully performed without complications. In 2 cases, the procedure was initially started with a conventional side-viewing EUS scope, but it proved impossible to puncture the pseudocyst. However, with the use of the forward-viewing EUS scope, both pseudocysts were successfully punctured., Limitations: Small sample size., Conclusions: Initial clinical experience with this novel prototype forward-view US endoscope for transmural drainage of pancreatic pseudocyst is favorable. It provides better control during puncturing of the cyst wall and creates a possibility to drain collections that are inaccessible with a conventional therapeutic side-viewing US endoscope.

Background: The cornerstone of management for acute cholecystitis is cholecystectomy. However, surgical intervention is contraindicated in the occasional patient. EUS-guided transduodenal gallbladder drainage may represent an effective minimally invasive alternative., Objectives: To describe a new technique, EUS-guided cholecystenterostomy., Design and Setting: A single-center retrospective case series., Patients: Three patients with severe acute cholecystitis unresponsive to conservative management who were deemed unfit for cholecystectomy., Interventions: Under combined EUS and fluoroscopic guidance, cholecystenterostomy was performed via needle puncture, guidewire insertion, cystoenterostome passage, and stent placement., Main Outcome Measures: Technical success, clinical progress, immediate and long-term complications, and recurrence of cholecystitis., Limitations: Pilot series., Results: Cholecystenterostomy was performed successfully in all patients. Rapid improvement in clinical status and inflammatory parameters ensued. A minor intraprocedural bile leak occurred in 1 patient, without significant clinical sequelae. Cholecystitis did not recur in any patient., Conclusions: EUS-guided cholecystenteric drainage is technically feasible and appears to be a safe and effective procedure. Via this technique, gallbladder drainage and resolution of related sepsis may be achieved in patients with acute cholecystitis who are unfit for surgery.

Background: Endoscopic transmural drainage is obtained by creating a communication between the intestinal tract and the pancreatic-fluid collection, and then inserting 1 or more stents. Collection recurrence after therapy is noted in 10% to 30% of cases. It is not known whether leaving the stents in position reduces recurrence rates., Objective: To test the hypothesis that patients who have undergone previous successful pancreatic-collection drainage and whose stents are retrieved have higher recurrence rates., Design: Randomized controlled trial., Setting: Tertiary referral center., Patients: During a period of 27 months, 46 of 77 patients who had undergone endoscopic transmural drainage for pancreatic collections met inclusion or exclusion criteria, and 28 of these patients were randomized., Interventions: Fifteen patients were assigned to group A, whose stents were left in place, and 13 were assigned to group B, whose stents were removed after collection resolution. The remaining 18 patients, who were not randomized, also had their stents left in place. All 46 patients were similarly followed., Main Outcome Measurement: Recurrence of the same pancreatic collection that required therapy., Results: All patients were followed for a median period of 14 months (interquartile range, 8.2-22 months) after treatment. The primary end point was reached in 5 patients in group B (stent retrieval), as opposed to none in group A (P = .013). Moreover, no recurrence was observed in the remaining 18 nonrandomized patients., Limitations: Small sample size., Conclusions: In patients who underwent successful transmural drainage of pancreatic collections, stent retrieval was associated with higher recurrence rates.

Background: EUS-guided pancreatogastrostomy (EPG) is described as an alternative to surgery for ductal decompression in symptomatic patients when endoscopic transpapillary access of the main pancreatic duct (MPD) is impossible., Objective: To present the midterm clinical response and follow-up of a larger group of patients treated with EPG and a new transbulbar approach, EUS-guided pancreatobulbostomy (EPB)., Design: Retrospective case review., Setting: Two tertiary referral centers in Brussels and Marseille., Patients: From 2000 to 2004, 36 patients (51 years old; range, 14-71 years) were seen., Intervention: EPG or EPB., Main Outcome Measurements: Pain relief, technical aspects, complications, and clinical follow-up., Results: Indications were chronic pancreatitis, with complete obstruction (secondary to a tight stenosis, a stone, or MPD rupture); inaccessible papilla or impossible cannulation (n = 20); anastomotic stenosis after a Whipple procedure (n = 12); complete MPD rupture after acute pancreatitis (AP); or trauma (n = 4). EPG or EPB was unsuccessful in 3 patients; 1 was lost to follow-up. Major complications occurred in 2 patients and included 1 hematoma and 1 severe AP. The median follow-up was 14.5 months (range, 4-55 months). Pain relief was complete or partial in 25 patients (69%, intention to treat). Eight patients treated had no improvement of their symptoms (4 were subsequently diagnosed with cancer). Stent dysfunction occurred in 20 patients (55%) and required a total of 29 repeat endoscopies., Limitations: Technically demanding and requires careful pretherapeutic evaluation., Conclusions: EPG or EPB appears to be an effective and relatively safe treatment for the management of pain secondary to pancreatic ductal hypertension in patients with an MPD not accessible by a transpapillary route.

Background: Pancreatic-fluid collections are frequent sequelae of acute and chronic pancreatitis, and endoscopic drainage of these collections has gained acceptance as an alternative to surgical drainage., Methods: Patient data, collection characteristics, drainage technique, and outcomes were obtained through chart review and prospective follow-up for 116 patients with attempted endoscopic drainage of symptomatic pancreatic-fluid collections., Results: A total of 116 patients presented with fluid collections classified as acute fluid collection (n = 5), necrosis (n = 8), acute pseudocyst (n = 30), chronic pseudocyst (n = 64), and pancreatic abscess (n = 9). The median diameter of the collection drained was 60 mm (15-275 mm). Median follow-up after drainage was 21 months. The drainage technique was transpapillary in 15 patients, transmural in 60, and both in 41. Successful resolution of symptoms and collection occurred in 87.9% of cases. No difference in success rates was observed between patients with acute pancreatitis and those with chronic pancreatitis. However, drainage of organized necrosis was associated with a significantly higher failure rate than other collections. No significant differences were observed regarding success when disease, drainage technique, or site of drainage was considered. Complications occurred in 13 patients (11%), and there were 6 deaths in the 30 days after drainage, including one that was procedure related., Conclusions: Endoscopic drainage of pancreatic-fluid collections is successful in the majority of patients and is accompanied by an acceptable complication rate.

Background: Although endoscopic palliation of malignant biliary hilar obstruction is preferable to surgery or percutaneous drainage, it remains technically challenging. This is especially true when multiple self-expanding metal stents (SEMS) are placed, because difficulty is commonly encountered in passing the second SEMS at the level of the previously deployed initial stent. We have devised a method of deploying multiple metal stents by using a temporary plastic stent, which makes deployment of the second stent much easier., Methods: After guidewire placement, a plastic stent is deployed in a subhilar position. The initial SEMS is deployed, with the plastic stent maintaining a passage for the second SEMS. After the second SEMS is deployed, the plastic stent is retrieved., Observations: This technique has been used successfully in 7/8 patients, all of whom presented with symptomatic jaundice secondary to malignant hilar obstruction of various etiologies (cholangiocarcinoma, n=4; metastatic disease, n=3; and hepatocellular carcinoma, n=1). Drainage was successful in all cases, with significant improvement in symptoms and cholestasis., Conclusions: This simple technique lessens the technical difficulty of placing bilateral hilar SEMS.

Background: Acute pancreatitis with pancreatic-duct rupture and fluid collections is a rare complication after Silastic ring vertical gastroplasty. It can be attributed to pancreatic trauma occurring during surgery., Methods: Endoscopic therapy with transmural drainage of collections was performed in 4 patients who had undergone Silastic ring vertical gastroplasty and who had presented with acute pancreatitis with main pancreatic-duct rupture at the body of the pancreas., Observations: All patients had successful transmural drainage with cystogastrostomy, followed by stent insertion. Only one patient had a late recurrence because of stent migration. The major difficulty was related to positioning of the endoscope and the possible need of pneumatic dilation of the outlet channel to reach the puncture site., Conclusions: Endoscopic therapy is useful in acute pancreatitis with pancreatic-duct rupture after Silastic-ring vertical gastroplasty and, although technically difficult, could be considered as a first-line approach in the management of these patients.

Background: A benign condition is a relative contraindication to the use of self-expanding metallic stents, because these devices usually are not retrievable. The self-expanding plastic stent is removable and induces less tissue hyperplasia. This study prospectively evaluated the use of a self-expanding plastic stent to treat benign esophageal conditions., Methods: Over 4 years, 21 patients underwent self-expanding plastic stent placement for various benign esophageal disorders, including refractory peptic (n = 2), caustic (n = 3), post-radiotherapy (n = 3), and anastomotic (n = 4) stenoses; hyperplastic (n = 5) stenosis within a previously implanted metallic stent; and anastomotic leak (n = 4) after esophagectomy. The self-expanding plastic stent was removed from all patients. Patients were followed for at least 8 months after stent removal., Results: Implantation was successful in all cases. Temporary self-expanding plastic stent placement was curative in 17/21 patients, especially those with caustic and hyperplastic strictures and anastomotic fistula, all of which were treated successfully without re-intervention. Median follow-up was 21 months (range 8-39 months) after stent removal. Moreover, by inducing tissue ischemia, self-expanding plastic stent allowed delayed removal of metallic stents. Only one severe complication (tracheal compression) was encountered, and this resolved after stent removal., Conclusions: A range of benign stenosing disorders of the esophagus can be treated safely with a self-expanding plastic stent. Because the long-term results were highly favorable, self-expanding plastic stent placement could be used as the initial treatment for various conditions. Self-expanding plastic stent insertion within an esophageal self-expanding metallic stent allowed removal of the latter, theoretically unretrievable, stent.

Background: Recently developed treatments for Zenker's diverticulum include the use of a flexible endoscope, which is minimally invasive. A new endoscopic approach is described that uses a soft diverticuloscope to provide perfect exposure of the operative site and stabilizes the endoscope., Methods: A total of 30 patients (15 men, 15 women; median age, 78 years) were treated with this diverticuloscope. All patients had significant symptoms including dysphagia (n = 24, 80%) and/or regurgitation (n = 17, 56%). Eighteen (60%) had a large diverticulum (>4 cm)., Results: All patients were successfully treated in a single session. In one patient, dysphagia persisted but was milder than before the treatment. A complication occurred in 4 patients (13%); in one (3%), it was severe. During follow-up (median, 12.5 months), dysphagia recurred in one patient 1 year after the initial procedure but was successfully re-treated with a CO(2) laser and rigid diverticuloscope. Four patients (13%) died during follow-up of causes unrelated to the treatment., Conclusions: Diverticulotomy with a flexible endoscope and soft diverticuloscope is an effective treatment for Zenker's diverticulum.

Background: A prerequisite for endoscopic drainage of pancreatic fluid collections without EUS is the presence of a visible bulge in the GI wall. Our experience with endoscopic cystostomy of nonbulging pancreatic fluid collections is described., Methods: Thirty-three patients underwent 34 endoscopic attempts at transmural drainage of nonbulging pancreatic fluid collections over a 2-year period. The etiology of the nonbulging pancreatic fluid collections was chronic pancreatitis in 26 cases and acute pancreatitis in 7. Indications for drainage included one or more of the following: abdominal pain, infection, biliary obstruction, and external fistula. The diameter of the collections ranged from 20 to 160 mm (median 52 mm)., Results: Thirty-two of 34 drainage attempts were successful (94%). Eighteen cystostomies were performed under fluoroscopy alone and 14 by EUS together with fluoroscopy. Procedure-related complications occurred with 3 of 34 attempts (8%). Surgery was not required for treatment of the complications and there were no deaths from the procedure. Follow-up was available for 31 patients (median 21 months, range 9 to 40 months). One nonbulging pancreatic fluid collections recurred 7 months after drainage., Conclusions: Endoscopic cystenterostomy of nonbulging pancreatic collections is feasible, and the results of the procedure are similar to those of cystenterostomy for bulging collections.

Background: GERD is the most frequent disorder of the esophagus. Endoscopic minimally invasive treatment is desirable. However, the results of injection techniques have been disappointing., Methods: A pilot study was conducted in patients with GERD, who required continuous therapy with a proton pump inhibitor, in which ethylene-vinyl-alcohol was injected into the muscle of the gastric cardia. Primary endpoints were the safety of the procedure, the effect on lower esophageal sphincter pressure and the stability of the injected material. A secondary endpoint was the effect on heartburn score after discontinuation of treatment with a proton pump inhibitor., Results: Ethylene-vinyl-alcohol injection into the cardia resulted in circular diffusion of the product in 10 of 15 cases, suggesting that implantation into the muscle is feasible. Lower esophageal sphincter pressure was increased in 13 of 15 cases at 1 month and was sustained at a median follow-up of 6 months (range 4-12 months). Mean plus minus SEM of lower esophageal sphincter pressures (15 patients) were 12.2 plus minus 0.9, 18.7 plus minus 1.5 (p = 0.001 at baseline), and 16.7 plus minus 1.3 mm Hg (p = 0.038 from baseline) at, respectively, baseline, 1 month follow-up, and final follow-up. There was also a sustained reduction in heartburn score (off proton pump inhibitor) (3.40 plus minus 0.13 vs. 1.53 plus minus 0.24 and 1.87 plus minus 0.26 at baseline vs. 1 month and final follow-up, respectively; p < 0.01). Nine of the 15 patients had more than 50% of the injected material in place at second follow-up (at 6 months for 8 patients; at 12 months for 1 patient). In only 2 patients was there loss of more than 75% of injected ethylene-vinyl-alcohol. Persistence of greater than 50% of the material was associated with achievement of a circular injection. Only 4 patients had to resume therapy with a proton pump inhibitor. Mild retrosternal discomfort was observed in 8 patients; this disappeared in all cases after a maximum of 3 days., Conclusions: Ethylene-vinyl-alcohol implantation in the muscle of the cardia is feasible and safe. It leads to a sustained increase in resting lower esophageal sphincter pressure. This is associated with a sustained improvement in heartburn score for patients who previously required continuous therapy with a proton pump inhibitor.