Diagnostic accuracy and interobserver agreement of cholangioscopy for indeterminate biliary strictures: A single-center experience.

BACKGROUND AND STUDY AIMS: Characterization of indeterminate biliary strictures (IDBS) still represents a major challenge. Digital single-operator cholangioscopy (DSOC) could potentially overcome limits of conventional biopsy and brush sampling. The aim of this study was to compare diagnostic accuracy of visual evaluation and DSOC-guided biopsies to conventional trans-papillary sampling techniques and to evaluate the inter-observer agreement (IOA) on visual diagnosis. PATIENTS AND METHODS: All consecutive patients undergoing DSOC-guided biopsy after conventional sampling techniques for IDBS during a six-year period were retrospectively evaluated. Final diagnosis was based on histological evaluation of the surgical specimen if available or a clinical follow-up of at least 6 months. For IOA, 20-second DSOC clips were retrospectively reviewed by 6 experts and 6 trainees and classified according to the Monaco Classification. RESULTS: Thirty-five patients underwent DSOC for IDBS in the study period; 14 patients (F = 9) with a median age of 64 years (range 53-76) met the study aim. After DSOC, strictures location was changed in three patients (additional yield of 21.4 %). Intraductal DSOC-guided biopsy were technically successful in all cases, with an adequacy of 92.8 %. No adverse events were recorded. Final diagnosis was benign disease in five cases and cholangiocarcinoma in the others. For IOA, 29 videos were evaluated with almost perfect agreement for final diagnosis (kappa 0.871; agreement 93.1, p <0.001), although overall accuracy of DSOC visual finding was 73.6 % and 64.4 % for experts and trainees, respectively. CONCLUSIONS: DSOC could improve diagnostic accuracy for IDBS, since it showed high sensitivity for visual finding and high specificity for DSOC guided-biopsy. Visual diagnosis seems reliable for diagnosis using the Monaco Classification.

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.

Durability of per-oral endoscopic myotomy beyond 6 years.

Background and study aims The aim of this study was to assess long-term clinical outcomes beyond 6 years in patients who underwent per-oral endoscopic myotomy (POEM) for the treatment of achalasia. Patients and methods Patients with achalasia who underwent POEM between 2010 and 2012 and had follow-up of at least 6 years were retrospectively identified at eight tertiary care centers. The primary outcome evaluated was clinical success defined by an Eckardt symptom score (ESS) ≤ 3 for the duration of the follow-up period. The clinical success cohort was compared to failure (ESS > 3 at any time during follow-up) in order to identify characteristics associated with symptom relapse. The incidence of patient-reported gastroesophageal reflux (GER) was also evaluated. Results Seventy-three patients with 6-year follow-up data were identified. Sustained clinical remission was noted in 89 % (65/73) at 6-years. Mean ESS decreased from 7.1 ±â€Š2.3 pre-procedure to 1.1 ±â€Š1.1 at 6 years ( P  < 0.001). Symptomatic reflux was reported by 27 of 72 patients (37.5 %). Type I achalasia (OR 10.8, P  = 0.04) was found to be associated with clinical failure on logistic regression analysis. Conclusions In patients with achalasia, POEM provides high initial clinical success with excellent long-term outcomes. There are high rates of patient-reported gastroesophageal reflux post-procedure which persist at long-term follow-up.

Personalized Endoscopy in Complex Malignant Hilar Biliary Strictures.

Malignant hilar biliary obstruction (HBO) represents a complex clinical condition in terms of diagnosis, surgical and medical treatment, endoscopic approach, and palliation. The main etiology of malignant HBO is hilar cholangiocarcinoma that is considered an aggressive biliary tract's cancer and has still today a poor prognosis. Endoscopy plays a crucial role in malignant HBO from the diagnosis to the palliation. This technique allows the collection of cytological or histological samples, direct visualization of the suspect malignant tissue, and an echoendoscopic evaluation of the primary tumor and its locoregional staging. Because obstructive jaundice is the most common clinical presentation of malignant HBO, endoscopic biliary drainage, when indicated, is the preferred treatment over the percutaneous approach. Several endoscopic techniques are today available for both the diagnosis and the treatment of biliary obstruction. The choice among them can differ for each clinical scenario. In fact, a personalized endoscopic approach is mandatory in order to perform the proper procedure in the singular patient.

Bilio-pancreatic endoscopy during COVID-19 pandemic.

On 31 December 2019, the WHO China Country Office was informed of cases of pneumonia of unknown etiology detected in Wuhan (Hubei Province of China). In January 2020, a new coronavirus named SARS-CoV2 was isolated and, since that time, SARS-CoV2 related disease (COVID-19) rapidly spread all over the world becoming pandemic in March 2020. The COVID-19 outbreak dramatically affected the public-health and the health-care facilities organization. Bilio-pancreatic endoscopy is considered a high-risk procedure for cross-contamination and, even though it is not directly involved in COVID-19 diagnosis and management, its reorganization is crucial to guarantee high standards of care minimizing the risk of SARS-CoV2 transmission among patients and health-care providers. Bilio-pancreatic endoscopic procedures often require a short physical distance between the endoscopist and the patient for a long period of time, a frequent exchange of devices, the involvement of a large number of personnel, the use of complex endoscopes difficult to reprocess. On this basis, endoscopic units should take precautions with adjusted management of bilio-pancreatic endoscopy. The aim of this article is to discuss the approach to bilio-pancreatic endoscopy in the COVID-19 era with focus on diagnostic algorithms, indications, management of the endoscopic room, proper use of Personal Protective Equipment and correct reprocessing of instrumentation.

Endoscopic snare papillectomy for adenoma of the ampulla of vater: Long-term results in 135 consecutive patients.

BACKGROUND: The premalignant nature of ampullary adenomas justifies their radical excision. AIMS: Aim of this study is to evaluate the long-term results of endoscopic snare papillectomy in a consecutive series of patients with ampullary adenomas. METHODS: Patients who underwent endoscopic snare papillectomy between October 1999 and October 2017 were identified from an electronic database. Endoscopic snare papillectomy was performed en bloc, when possible; a pancreatic stent or a nasopancreatic drainage were inserted. Endoscopic follow-up was scheduled after 3, 6 and 12 months for the first year, then yearly. RESULTS: Endoscopic snare papillectomy was performed in 135 patients (70 M, mean age 60.5 years) by en bloc (83%) or piecemeal (17%) resection. Delayed bleeding occurred in 16 patients (11.8%), infected retroperitoneal collections in 6 patients (4.4%), pancreatitis in 4 patients (3%). One patient died (0.7%). Follow-up was available in 103/114 (90.3%) patients. In case of residual (24.3%) and recurrent (23.3%), adenomas endoscopic retreatment was successful in 42/49 cases (85.7%). After a mean follow-up of 40 months, 93.2% (96/103) of the patients were disease free CONCLUSION: Endoscopic snare papillectomy of ampullary adenomas is effective with favorable long-term outcomes. Compliance to the scheduled follow-up is important for the early detection and re-treatment of recurrences.

Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 4†years: a multicenter study.

Background and study aims Per-oral endoscopic myotomy (POEM) is associated with a short-term clinical response of 82 % to 100 % in treatment of patients with achalasia. Data are limited on the long-term durability of the clinical response in these patients. The aim of this study was to determine the long-term outcomes of patients undergoing POEM for management of achalasia. Methods This was a retrospective multicenter cohort study of consecutive patients who underwent POEM for management of achalasia. Patients had a minimum of 4 years follow-up. Clinical response was defined by an Eckardt score ≤ 3. Results A total of 146 patients were included from 11 academic medical centers. Mean (±â€ŠSD) age was 49.8 (±â€Š16) years and 79 (54 %) were female. The most common type of achalasia was type II, seen in 70 (47.9 %) patients, followed by type I seen in 41 (28.1 %) patients. Prior treatments included: pneumatic dilation in 29 (19.9 %), botulinum toxin injection in 13 (8.9 %) and Heller myotomy in seven patients (4.8 %). Eight adverse events occurred (6 mucosotomies, 2 pneumothorax) in eight patients (5.5 %). Median follow-up duration was 55 months (IQR 49.9-60.6). Clinical response was observed in 139 (95.2 %) patients at follow-up of ≥ 48 months. Symptomatic reflux after POEM was seen in 45 (32.1 %) patients, while 35.3 % of patients were using daily PPI at 48 months post POEM. Reflux esophagitis was noted in 16.8 % of patients who underwent endoscopy. Conclusion POEM is a durable and safe procedure with an acceptably low adverse event rate and an excellent long-term clinical response.

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.

Poem Versus Laparoscopic Heller Myotomy in the Treatment of Esophageal Achalasia: A Case-Control Study from Two High Volume Centers Using the Propensity Score.

BACKGROUND: POEM has recently had a widespread diffusion, aiming at being the treatment of choice for esophageal achalasia. The results of ongoing RCTs against laparoscopic myotomy are not available, yet. We, therefore, designed this propensity score (PS) case-control study with the aim of evaluating how POEM compares to the long-standing laparoscopic Heller myotomy + Dor fundoplication (LHD) and verifying if it may really replace the latter as the first-line treatment for achalasia. METHODS: Two groups of consecutive patients undergoing treatment for primary achalasia from January 2014 to November 2017 were recruited in two high-volume centers, one with extensive experience with POEM and one with LHD. Patients with previous endoscopic treatment were included, whereas patients with previous LHD or POEM were excluded. A total of 140 patients in both centers were thus matched. LHD and POEM were performed following established techniques. The patients were followed with clinical (Eckardt score), endoscopic, and pH-manometry evaluations. RESULTS: The procedure was successfully completed in all the patients. POEM required a shorter operation time and postoperative stay compared to LHD (p < 0.001). No mortality was recorded in either group. Seven complications were recorded in the POEM group (five mucosal perforations) and 3 in the LHD group (3 mucosal perforations)(p = 0.33). Two patients in the POEM group and one in the LHD were lost to follow-up. One patient in both groups died during the follow-up for unrelated causes. At a median follow-up of 24 months [15-30] for POEM and 31 months [15-41] for LHD (p < 0.05), 99.3% of the POEM patients and 97.7% of the LHD patients showed an Eckardt score ≤ 3 (p < 0.12). Four years after the treatment, the probability to have symptoms adequately controlled was > 90% for both groups (p = 0.2, Log-rank test). HR-Manometry showed a similar reduction in the LES pressure and 4sIRP; 24-h pH-monitoring showed however an abnormal exposure to acid in 38.4% of POEM patients, as compared to 17.1% of LHD patients (p < 0.01) and esophagitis was found in 37.4% of the POEM and 15.2% of LHD patients (p < 0.05). CONCLUSION: POEM provides the same midterm results as LHD. This study confirms, however, a higher incidence of postoperative GERD with the former, even if its real significance needs to be further evaluated.

A 17 years retrospective study on multiple metal stents for complex malignant hilar biliary strictures: Survival, stents patency and outcomes of re-interventions for occluded metal stents.

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.

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.

Fully covered self-expandable metal stents to dilate persistent pancreatic strictures in chronic pancreatitis: long-term follow-up from a prospective study.

BACKGROUND AND AIMS: Symptomatic main pancreatic duct (MPD) strictures secondary to chronic pancreatitis (CP) may benefit from endoscopic insertion of single or multiple plastic stents. MPD stricture resolution after single plastic stent removal is uncommon. The use of removable fully covered, self-expandable metal stents (FC-SEMSs) to dilate MPD strictures secondary to CP was evaluated. METHODS: Patients with CP and symptomatic MPD stricture located in the head of the pancreas persisting for 3 months or more after placement of a single plastic stent were enrolled in a prospective single-arm trial. A nitinol FC-SEMS was inserted and removed after 6 months. The FC-SEMS diameter and length were chosen according to the stricture anatomy and MPD diameter above the stricture. Our primary objective was FC-SEMS removability. Secondary outcomes were MPD stricture resolution rate and adverse events. RESULTS: Between December 2012 and October 2014, 15 patients (10 male, mean age 60 years) were enrolled. Pancreatic calcifications were present in 6 (40%) patients. Four patients (27%) had a history of alcohol abuse. In 10 patients, the FC-SEMS was inserted through the major papilla, whereas 5 patients (3 pancreas divisum, 2 dominant dorsal duct) received the stent through the minor papilla. One patient developed cholangitis after 24 hours due to occlusion of the biliary sphincterotomy from the FC-SEMS; cholangitis resolved after insertion of a plastic biliary stent. Complete distal migration of the FC-SEMS was reported in 7 patients (47%) (5 asymptomatic, 2 symptomatic with recurrence of pancreatitis). All migrations occurred with the 3-cm-long FC-SEMS. Four patients (27%) developed de novo stricture induced by the FC-SEMS at the level of the flared end and were excluded from the follow-up; 1 patient with FC-SEMS migration had failed stricture resolution. One patient was lost to follow-up. Finally, 9 patients with MPD stricture resolution had a mean follow-up of 38.9 months (range, 5.3-55.3 months), and 89% were asymptomatic. CONCLUSIONS: FC-SEMS removability from the MPD in CP was feasible in all cases, and 90% of the patients were asymptomatic after 3 years. Migration seems more frequent with the 3-cm-long FC-SEMS. Occurrence of FC-SEMS-induced pancreatic strictures is a major issue and deserves further assessment. According to our experience, pancreatic FC-SEMSs have promising results, but a careful evaluation in the setting of clinical trials is needed.

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.

Effectiveness of Mesalazine, Thiopurines and Tumour Necrosis Factor Antagonists in Preventing Post-Operative Crohn's Disease Recurrence in a Real-Life Setting.

BACKGROUND: Most Crohn's disease (CD) patients develop endoscopic recurrence within one year of intestinal resection. The best treatment method to prevent post-operative CD recurrence remains uncertain. METHODS: A total of 155 CD patients from 2 referral centres, who were undergoing intestinal resection with ileo-colonic anastomosis (January 2004-January 2015), were included. All subjects received preventive therapy with tumour necrosis factor antagonists (anti-TNFs), thiopurinesor mesalazine. The primary outcome was the rate of endoscopic recurrence (Rutgeerts score ≥i2) in the 3 treatment groups. RESULTS: Patients treated with anti-TNFs were at significantly lower risk of endoscopic recurrence during the follow-up than those receiving thiopurines or mesalazine (incidence rates of 2.2, 3.0 and 4.8 per 100 person-months, respectively, log-rank, p = 0.011). The median time to recurrence was significantly longer in patients treated with anti-TNFs than in those who received thiopurines or mesalazine (37.0, 13.7, and 16.8 months, respectively, log-rank, p = 0.011). Anti-TNFs were more effective than mesalazine (univariable analysis, hazard ratio [HR] 0.45, 95% CI 0.26-0.77, p = 0.004; multivariable analysis, HR 0.45, 95% CI 0.26-0.77, p = 0.004), and non-significantly superior over thiopurines. CONCLUSION: Anti-TNF therapy was the most effective strategy for the prevention of endoscopic CD recurrence.

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.