Double-Blind Multicenter Randomized Clinical Trial Comparing Glucagon vs Placebo in the Resolution of Alimentary Esophageal Impaction.

INTRODUCTION: The aim of this study was to compare the effectiveness of glucagon vs placebo in resolving esophageal foreign body impaction (EFBI), as well as the length of the procedure and adverse events. METHODS: This was a multicenter, randomized, double-blind trial involving consecutive patients diagnosed with alimentary EFBI. Participants were randomized to receive either 1 mg of intravenous glucagon or placebo. All patients underwent upper endoscopy, and adverse events were assessed through a protocolized telephonic interview 7 days later. RESULTS: The study included 72 subjects in the glucagon group and 68 in the placebo group. The foreign body was not identified in 23.6% of subjects in the glucagon group and 20.6% of subjects in the placebo group (difference 3%, 95% confidence interval -10.7% to 16.8%, P = 0.67). The median time required to remove the foreign body was similar in both groups 4 minutes (range 2-10) in the glucagon group and 3.5 minutes (range 2-7) in the placebo group (difference 0.5 minutes, 95% confidence interval -1.3 to 2.3; P = 0.59). The most common adverse event reported in both groups was mild pharyngeal pain. DISCUSSION: Glucagon is no more effective than placebo in resolving EFBI or shortening the time required to remove the foreign body (EUDRA-CT number 2019-004920-40).

Influence of familial forms of inflammatory bowel disease on the use of immunosuppressants, biological agents, and surgery in the era of biological therapies. Results from the ENEIDA project.

BACKGROUND AND AIMS: Familial inflammatory bowel disease (IBD) history is a controversial prognostic factor in IBD. We aimed to evaluate the impact of a familial history of IBD on the use of medical and surgical treatments in the biological era. METHODS: Patients included in the prospectively maintained ENEIDA database and diagnosed with IBD after 2005 were included. Familial forms were defined as those cases with at least one first-degree relative diagnosed with IBD. Disease phenotype, the use of biological agents, or surgical treatments were the main outcomes. RESULTS: A total of 5263 patients [2627 Crohn's disease (CD); 2636 ulcerative colitis (UC)] were included, with a median follow-up of 31 months. Of these, 507 (10%) corresponded to familial forms. No clinical differences were observed between familial and sporadic IBD forms except a lower age at IBD diagnosis and a higher rate of males in familial forms of UC. In CD, the proportions of patients treated with thiopurines (54.4% vs 46.7%; P = .015) and survival time free of thiopurines (P = .009) were lower in familial forms. No differences were found regarding the use of biological agents. Concerning surgery, a higher rate of intestinal resections was observed in sporadic CD (14.8% vs 9.9%, P = .027). No differences were observed in UC. CONCLUSIONS: In the era of biological therapies, familial and sporadic forms of IBD show similar phenotypes and are managed medically in a similar way; whether these is due to lack of phenotypical differences or an effect of biological therapies is uncertain. What is already known on this topic: IBD's etiopathogenesis points to an interaction between environmental and genetic factors, being familial history a controversial prognostic factor. Biological agents use and need for surgery regarding familial or sporadic forms of IBDs present conflicting results. What this study adds: Familial and sporadic forms of IBD have similar phenotypes and are managed medically and surgically in a similar way. How this study might affect research, practice or policy: Familial aggregation should not be considered a factor associated with more aggressive disease.

Antimigration versus conventional fully covered metal stents in the endoscopic treatment of anastomotic biliary strictures after deceased-donor liver transplantation.

INTRODUCTION: Migration of fully covered metal stents (FCMS) remains a limitation of the endoscopic treatment of anastomotic biliary strictures (ABS) following orthotopic liver transplantation (OLT). The use of antimigration FCMS (A-FCMS) might enhance endoscopic treatment outcomes for ABS. METHODS: Single center retrospective study. Consecutive patients with ABS following OLT who underwent ERCP with FCMS placement between January 2005 and December 2020 were eligible. Subjects were grouped into conventional-FCMS (C-FCMS) and A-FCMS. The primary outcome was stent migration rates. Secondary outcomes were stricture resolution, adverse event, and recurrence rates. RESULTS: A total of 102 (40 C-FCMS; 62 A-FCMS) patients were included. Stent migration was identified at the first revision in 24 C-FCMS patients (63.2%) and in 21 A-FCMS patients (36.2%) (p = 0.01). The overall migration rate, including the first and subsequent endoscopic revisions, was 65.8% in C-FCMS and 37.3% in A-FCMS (p = 0.006). The stricture resolution rate at the first endoscopic revision was similar in both groups (60.0 vs 61.3%, p = 0.87). Final stricture resolution was achieved in 95 patients (93.1%), with no difference across groups (92.5 vs 93.5%; p = 0.84). Adverse events were identified in 13 patients (12.1%) with no difference across groups. At a median follow-up of 52 (IQR: 19-85.5) months after stricture resolution, 25 patients (24.5%) developed recurrences, with no difference across groups (C-FCMS 30% vs A-FCMS 21%; p = 0.28). CONCLUSIONS: The use of A-FCMS during ERCP for ABS following OLT results in significantly lower stent migration rates compared to C-FCMS. However, the clinical benefit of reduced stent migration is unclear. Larger studies focusing on stricture resolution and recurrence rates are needed.

Prospective cohort study to evaluate premedication with simethicone and n-acetilcysteine for upper diagnostic gastrointestinal endoscopy.

INTRODUCTION: The use of premedication for upper gastrointestinal endoscopy (UGE) is not widely established in western countries. The primary aim of the study was to compare gastric visibility according to the total visibility score (TVS). The secondary aim was to assess complications, diagnostic yield, endoscopic procedure time, sedation dose and patient satisfaction. METHODS: A single center prospective cohort study was performed of consecutive adults undergoing an UGE in the afternoon working shift. After completing enrolment in the control group, patients were administered 200 mg simethicone and 500 mg N-acetylcysteine diluted in 100 ml of water >15 minutes before the procedure. All procedures were recorded and a single, blinded endoscopist evaluated the TVS after recruitment of both cohorts. Patient satisfaction was evaluated using the Spanish translation of the American Society of Gastrointestinal Endoscopy satisfaction questionnaire. RESULTS: 205 patients were included in the study, 103 females (50.2%) with a median age of 54.8-years (IQR: 41.2-65.2). 104 were enrolled to the control group and 101 to the intervention group. Patients receiving premedication presented a higher rate of adequate (74.3% vs 45.2; difference 95% CI: 16,3-41,9%, p<0.001) and excellent gastric visibility (23.8% vs 7.7%; difference 95% CI: 6,3-25,8%, p=0.002). Propofol dose was similar, although the median procedure time was lower in the group of no intervention [5 (IQR: 4-7) vs 6 minutes (IQR: 5-7); p=0.03]. Procedure related adverse events were similar, except that patient without premedication experienced more nausea episodes. Major and minor endoscopic findings and the satisfaction questionnaire showed no differences between both groups. CONCLUSION: Patients receiving premedication with simethicone and N-acetylcysteine had a better gastric visibility score, without any increase in adverse events or affecting the patients' satisfaction.

SEED Consensus Document on SpyGlass-DS. / Documento de consenso de la Sociedad Española de Endoscopia Digestiva sobre SpyGlass-DS.

Endoscopic retrograde cholangiopancreatography (ERCP) is the technique of choice for the treatment of biliopancreatic pathology. However, fluoroscopic imaging does not always allow an adequate diagnosis. On the other hand, some large stones cannot be removed by the usual methods. In these situations, cholangioscopy has proven to be an essential tool for the diagnosis of biliary strictures and the treatment of large stones. Its role in pancreatic pathology is also increasing. The development of a single-operator, disposable cholangioscope has made it possible to expand the technique to a large number of hospitals that perform ERCP. For this reason, the Spanish Society of Digestive Endoscopy has developed this consensus document on the use of the Spyglass-DS cholangioscope. The document has been prepared by a group of endoscopists with expertise in cholangioscopy, reviewing the scientific evidence on the main current indications for cholangiopancreatoscopy.

Combined endoscopic retrograde and endosonography-guided (CERES) cholangiography for interventional repair of transected bile ducts after cholecystectomy: treatment approaches and outcomes.

BACKGROUND: Post-cholecystectomy transected bile ducts (TBDs) are not amenable to standard endoscopic management. Combined ERCP and endosonography (CERES) including EUS-guided hepaticoenterostomy enhance therapeutic biliary endoscopy. CERES treatment of post-cholecystectomy TBDs is evaluated. METHODS: Among 165 consecutive patients who underwent ERCP for post-cholecystectomy bile duct injury (Amsterdam A/B/C/D grades [%] = 47/30/7/16) between January 2009-November 2020 at a tertiary-care center, 10/26 (38%) with TBDs (6 female; 32-92 years old) underwent CERES before attempted endoscopic repair (staged CERES, n = 7) or surgical repair (preoperative CERES, n = 1), or as destination therapy (definitive CERES, n = 2). Short-term clinical success rate, final clinical success rate and comprehensive complication index (CCI) were retrospectively determined. Additionally, number of follow-up procedures, adverse events, recurrences, final patency grades and definitive cure rate were determined in patients with staged CERES. RESULTS: Index CERES (hepaticogastrostomy, 60%; hepaticoduodenostomy, 40%) achieved bile leak and jaundice resolution in 10 patients (100% short-term clinical success rate). Overall, 9/10 patients maintained good/excellent biliary drainage over a median 3.2 years without any unplanned percutaneous/surgical procedures (90% final clinical success rate; median CCI = 8.7). Staged CERES using recanalization (n = 6) or diversion (n = 1) strategies achieved Grade A patency in 5/7 (71%) patients after a median of 2 follow-up procedures over a median 12-month treatment period; 2 failed recanalization patients were salvaged by indefinite hepaticoenterostomy stent or elective surgery, respectively. Among staged CERES, 2 treatment-related cholangitis occurred (29%) and 2 recurring strictures (29%) developed over a median 8.4 year follow-up; recurring strictures were endoscopically remodeled (n = 1) or indefinitely stented (n = 1); final Grade A/B biliary patency was achieved in 5/7 (71%) and definitive cure in 4/7 (57%). CONCLUSIONS: CERES controls acute symptoms in selected post-cholecystectomy TBD patients allowing subsequent staged endoscopic therapy. Definitive cure or long-term biliary drainage is possible in most cases and elective surgery can be facilitated in the remainder.

Reply to: "Does it matter which plastic stents we use for the treatment of post-surgical leaks? Or is it a one-size-fits-all?"

We appreciate the interest of Sánchez-Luna et al. in our article "Endoscopic internal drainage using transmural double-pigtail stents in leaks following upper gastrointestinal tract surgery", and find their suggestion about using softer urological double pigtail stents (DPS) for endoscopic internal drainage (EID) interesting.

The role of endoscopic ultrasound guidance for biliary and pancreatic duct access and drainage to overcome the limitations of ERCP: a retrospective evaluation.

BACKGROUND: Endoscopic ultrasound (EUS)-guided ductal access and drainage (EUS-DAD) of biliary/pancreatic ducts after failed endoscopic retrograde cholangiopancreatography (ERCP) is less invasive than percutaneous transhepatic biliary drainage (PTBD). The actual need for EUS-DAD remains unknown. We aimed to determine how often EUS-DAD is needed to overcome ERCP failure. METHODS: Consecutive duct access procedures (n = 2205; 95 % biliary) performed between June 2013 and November 2015 at a tertiary-care center were reviewed. ERCP was used first line, EUS-DAD as salvage after ERCP, and PTBD when both had failed. Procedures were defined as "index" in patients without prior endoscopic duct access and "combined" when EUS-DAD followed successful ERCP. The main outcomes were the EUS-DAD and PTBD rates. RESULTS: EUS-DAD was performed in 7.7 % (170/2205) of overall procedures: 9.1 % (116/1274) index and 5.8 % (54/931) follow-up. Most index EUS-DADs were performed following (46 %) or anticipating (39 %) ERCP failure, whereas 15 % followed successful ERCP (combined procedures). Among index procedures, the EUS-DAD rate was higher in surgically altered anatomy (58.2 % [39 /67)] vs. 6.4 % [77/1207]); PTBD was required in 0.2 % (3/1274). Among follow-up procedures, ERCP represented 85.7 %, cholangiopancreatography through mature transmural fistulas 8.5 %, and EUS-DAD 5.8 %; no patient required PTBD. The secondary PTBD rate was 0.1 % (3/2205). Six primary PTBDs were performed (overall PTBD rate 0.4 % [9/2205]). CONCLUSIONS: EUS-DAD was required in 7.7 % of ERCPs for benign and malignant biliary/pancreatic duct indications. Salvage PTBD was required in 0.1 %. This high EUS-DAD rate reflects disease complexity, a wide definition of ERCP failure, and restrictive PTBD use, not poor ERCP skills. EUS-DAD effectively overcomes the limitations of ERCP eliminating the need for primary and salvage PTBD in most cases.

Lumen apposing metal stents versus tubular self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy in malignant biliary obstruction.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) is an effective option for biliary drainage in malignant biliary obstruction. Lumen apposing metal stents (LAMS) are increasingly been used for EUS-CDS. It is unknown how LAMS compare to tubular self-expandable metal stents (SEMS) for EUS-CDS. Our aim is to compare the clinical outcomes of LAMS versus SEMS for EUS-CDS. PATIENTS AND METHODS: Single-center retrospective cohort study of consecutive patients with unresectable malignant biliary obstruction who underwent EUS-CDS after failed ERCP for initial biliary drainage between 2011 and 2019. Clinical outcomes were compared between patients who had conventional covered SEMS and LAMS placed for EUS-CDS. Outcome measures included unplanned procedural events, technical success, clinical success, adverse events and reinterventions. Survival was analyzed by the Kaplan-Meier method. RESULTS: During the study period 57 patients met inclusion criteria (37 LAMS, 20 SEMS). All EUS-CDS were technically successful (LAMS group 95% CI 90.3-100%, SEMS group 95% CI 83.2-100%). There were no differences between groups in unplanned procedural events (4 LAMS deployment issues, 2 mild bleeding in SEMS group; 10 vs 10.8%), clinical success (37/37 [100%] vs 19/20 [95%]), and short-term adverse events (5/37 [13.5%] vs 4/20 [20%], p = 0.71). Complete follow-up data were available in 41 patients for a mean of 376 ± 145 days. Endoscopic reintervention was required for duodenal stent placement (n = 9) or biliary stent dysfunction (n = 4), with no difference between LAMS and SEMS group (6/37 [16.2%] vs 7/20 [35%]). There were no differences in overall survival between both groups. CONCLUSIONS: EUS-guided choledochoduodenostomy after failed ERCP has equally high technical and clinical success rates with either LAMS or SEMS in patients with malignant biliary obstruction. No differences in adverse events, reinterventions and survival were seen with either type of stent. The cost-effectiveness of LAMS vs SEMS for EUS-guided choledochoduodenostomy remains to be proven.

Endoscopic internal drainage using transmural double-pigtail stents in leaks following upper gastrointestinal tract surgery.

INTRODUCTION: different endoscopic procedures have been proposed for the management of surgical leaks. Endoscopic internal drainage using trans-fistulary double-pigtail plastic stents has emerged as an alternative strategy, especially in fistulae presenting after laparoscopic gastric sleeve. METHODS: a retrospective case series was performed at a single tertiary care center including all upper gastrointestinal post-surgical leaks primarily managed with endoscopic trans-fistulary insertion of double-pigtail plastic stents. Clinical success was defined as the absence of extravasation of oral radiographic contrast and radiological resolution of the collection with adequate oral intake Results: nine patients were included, six (66.6 %) females with a median age of 52.6 years (IQR 47-60). Five cases presented after laparoscopic gastric sleeve, two cases after distal esophagectomies, one after a Roux-en-Y gastric bypass and another one after a pancreaticoduodenectomy. Fistulae measured < 10 mm in five patients (55.6 %) and 10-20 mm in four patients (44.4 %). Six were early leaks. Technical and clinical success was achieved in nine (100 %) and seven (77.8 %) cases, respectively. Seven (77.8 %) patients required ≤ 3 endoscopic procedures. The median hospital stay after the first endoscopic procedure was 12 days (IQR 6.5-17.5 days), while the overall median time until leak healing was 118.5 days (IQR 84.5-170). One patient with a post-esophagectomy intrathoracic leak developed an esophageal-tracheal fistula 37 days after stent deployment. CONCLUSIONS: our results support the use of endoscopic internal drainage in postsurgical abdominal leaks, regardless of the type of surgery. Although only two patients with intrathoracic dehiscence were included.

Obliteration of gastric varices guided by eco-endoscopy with coils insertion coated with expandable hydrogel polymers.

INTRODUCTION: gastric varices hemorrhage is a severe complication of portal hypertension, with high mortality rates and few management alternatives, especially when there is a contraindication to transjugular intrahepatic portosystemic shunts (TIPS). The usual therapeutic options are the injection of cyanoacrylate, the insertion of coils or both. Hydrocoils are special coils coated with different types of expandable hydrogel polymers conventionally used in neurovascular interventionism. They allow rapid occlusion of vessel, forming a mesh that favors the local formation of thrombus and the development of a neointima on the gel cover. We consider the use of endoscopic ultrasound (EUS) guided hydrocoil insertion in gastric varices, without using cyanoacrylate. OBJECTIVE: this study aimed to evaluate the safety and effectivity of the application of EUS-guided hydrocoils in patients with gastric varices hemorrhage with TIPS contraindication. MATERIAL AND METHODS: this was a retrospective case series of four patients with TIPS contraindication after interventional radiologist evaluation. Linear echoendoscopes, fluoroscopy, 19G needles and hydrocoils (Azur®, Terumo) and Progreat® 3 Fr microcatheters were used. An interventional radiologist expert advised the procedures and endoscopic ultrasound confirmed the varix obliteration. RESULTS: technical and clinical success occurred in all patients involved in this study. There were no adverse effects related to the procedure or endoscopic equipment damage. CONCLUSIONS: the application of EUS-guided hydrocoils can be a safe and effective method in the short term for gastric varices bleeding in patients who are not candidates for TIPS. Besides, a complete obliteration of the vascular lumen could occur and thus, dispense with the use of cyanoacrylate. Further studies are needed to corroborate these preliminary results.

CHOLANGIOPANCREATOSCOPY. WORKING PROTOCOL. SEED Recommendations.

Direct endoscopic visualization of biliary and pancreatic ducts represents one step further in the journey of digestive endoscopy. It allows the identification of lesions that were previously attainable through indirect means. Directed biopsy taking has permitted a better characterization of the lesions. The use of power sources through the cholangiopancreatoscope means that it is now possible to fragment and remove refractory lithiases using traditional endoscopic systems. This document aims to define the advisable workflow when using a single-use, flexible cholangiopancreatoscope with the commercial name of SpyGlass®. Penning a set of guidelines to provide instructions on the technique, as well as tips and tricks related with the operation of these endoscopes will be a useful resource.

Safety and efficacy of endoscopic ultrasound-guided gallbladder drainage combined with endoscopic retrograde cholangiopancreatography in the same session.

BACKGROUND AND AIM: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is an emerging option for acute cholecystitis in non-surgical candidates. Combining endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones with EUS-GBD in a single session might become a non-surgical management strategy to comprehensively treat gallstone disease in selected patients. METHODS: Single-center retrospective cohort study comparing outcomes between EUS-GBD alone (group A) and single-session ERCP combined with EUS-GBD (group B). Consecutive patients who underwent EUS-GBD with a lumen-apposing metal stent (LAMS) between June 2011 and August 2018 were analyzed. Exclusion criteria were subjects included in randomized clinical trials, patients who had had ERCP within 5 days of EUS-GBD, patients in whom ERCP or EUS-GBD was carried out for salvage of one or the other procedure, and patients who underwent concurrent EUS-guided biliary drainage. RESULTS: One hundred and nine consecutive patients underwent EUS-GBD with LAMS during the study period. Seventy-one patients satisfied the inclusion criteria and 34 patients were in group A and 37 in group B. Baseline characteristics were similar in both groups. There were no significant differences in technical (97.1% vs 97.3%; P = 0.19) and clinical success rates (88.2% vs 94.6%; P = 0.42) of EUS-GBD in group A versus group B. Rate of adverse events was similar in both groups, five (14.7%) in group A versus five (13.5%) in group B. CONCLUSIONS: Single-session EUS-GBD combined with ERCP has comparable rates of technical and clinical success to EUS-GBD alone. A combined EUS-GBD and ERCP procedure does not appear to increase adverse events and makes possible comprehensive treatment of gallstone disease by purely endoscopic means.

Endoscopic ultrasound-guided fine-needle aspiration for splenomegaly and focal splenic lesion: is it safe, effective and necessary?

INTRODUCTION: splenomegaly and/or focal splenic lesions (FSL) have limited histopathologic studies due to the risk posed by splenic punctures. Percutaneous biopsies with a fine needle are difficult, especially due to interposition of gases, ascites, obesity or a history of abdominal surgery. On the other hand, endoscopic ultrasound (EUS) takes advantage of the proximity of the gastric wall to the spleen in order to puncture and visualize the needle and its movements in real time. OBJECTIVE: to describe the initial experience and results obtained with EUS-FNA in patients with splenomegaly or FSL. MATERIALS AND METHODS: this was a descriptive observational study. EUS-FNA of the spleen was performed with a slow-pull technique, which avoided fanning with an average of 3 needle passes. Biopsies were sent in Cytorich RedTM solution for analysis by cytology and cell block. RESULTS: punctures were performed in 15 patients (9 females) and the median age was 67 years (range 44-86). Patients studied due to an enlarged spleen or splenic FSL, in the context of fever of an unknown origin, adenopathies and abnormal weight loss were included. A conclusive diagnosis was achieved by EUS-FNA in 10 patients (66.7 %), 4 were large cell type B non-Hodgkin's lymphoma and one Hodgkin's lymphoma. There were no immediate or delayed complications related to the procedure. CONCLUSIONS: EUS-guided splenic punctures appear to be safe, effective and may be necessary in some clinical settings in order to complete the etiologic filiation of splenomegaly of an uncertain origin or FSL and to rule out malignancy.

Satisfaction with care in colorectal cancer patients: inpatient versus outpatient study.

BACKGROUND: satisfaction with healthcare is focused on the patient and is known as "patient-centered care". However, user satisfaction is not always synonymous with good care. Healthcare practitioners should determine and understand what patients need and expect in order to improve the quality of care. AIMS: the main objective of this study was to determine the perceived quality of care of patients diagnosed with colorectal cancer in our unit. METHODS: a cross-sectional study was performed in all patients diagnosed with colorectal cancer (CRC) that underwent staging studies and were hospitalized in the Gastroenterology Department from May 2013 to October 2013. Furthermore, outpatients with rapid consultations for CRC staging from November 2013 to November 2014 were also included. Two questionnaires were administered: a) a survey of 20 questions with closed responses regarding the competence of treating physicians and nurses, the information received and the waiting time; b) the European Organization for Research and Treatment of Cancer (EORTC) QLQ-INFO25: information on the disease, medical tests, treatment and other services, with eight single items. RESULTS: there were no differences in the perceived healthcare quality, delays in starting treatment, the tumor stage, symptoms (performance status) or the time spent studying the disease. In-patients and those with advanced disease started treatment earlier than outpatients and those with disease stage I or II. Likewise, outpatients perceived a better psychological support. CONCLUSIONS: outpatient study did not reduce the quality of care and did not delay treatment.

Cumulative risks of stent migration and gastrointestinal bleeding in patients with lumen-apposing metal stents.

BACKGROUND: Delayed gastrointestinal (GI) bleeding and stent migration are known adverse events which may occur following placement of lumen-apposing metal stents (LAMSs). METHODS: All consecutive patients who underwent LAMS placement between May 2011 and June 2017 at a single tertiary medical center were included. Demographics and procedural details were prospectively collected. Post-procedure follow-up and outcome measures were retrospectively collected. The cumulative risks of migration and LAMS-related GI bleeding were estimated using the life-table method. Risk predictors were assessed using Cox proportional hazards models. RESULTS: We analyzed 250 patients (64.8 % men; median age 71.6 [interquartile range (IQR) 57.9 - 83.6]). Median follow-up was 78.5 days (IQR 31 - 246.5 days). Thirty-four stent migrations (13.6 %) occurred (5 symptomatic). On multivariable analysis, associations with migration included nasocystic drains (hazard ratio [HR] 6.5, 95 % confidence interval [CI] 2.2 - 19.3), pancreatic fluid collections (PFCs; HR 4.2, 95 %CI 1.8 - 10.1), and double-pigtail stents (HR 2.4, 95 %CI 1.2 - 4.9). Migration risk at 12 months was 25.5 % (95 %CI 17.9 % - 35.7 %) and was higher for PFCs 48.9 % (33.4 % - 66.9 %) than other indications 8.4 % (4.9 % - 17.5 %; P < 0.001). LAMSs placed for longer durations (i. e. enteral anastomoses, biliary and gallbladder drainage) presented an 8.4 % cumulative risk at 2 years. There were 13 LAMS-related GI hemorrhages (5.2 %), two of them fatal, presenting a median of 3 days (IQR 1 - 9 days) after deployment. The cumulative risk of bleeding at 12 months was 6.9 % (3.6 % - 12.7 %). CONCLUSIONS: LAMS migration occurs in 1 out of 7 cases and is most common when treating PFCs. Bleeding related to LAMS placement occurs much less commonly but can be life-threatening.