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).

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.

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

La colangiopancreatografía retrógrada endoscópica (CPRE) es la técnica de elección para el tratamiento de la patología biliopancreática. Sin embargo, las imágenes fluoroscópicas no siempre permiten un diagnóstico adecuado. Por otra parte, algunos cálculos de gran tamaño no se pueden extraer con los métodos habituales. En estas situaciones, la colangioscopia ha mostrado ser una herramienta fundamental para el diagnóstico de las estenosis biliares y el tratamiento de los cálculos de gran tamaño. Además, su papel en la patología pancreática está en creciente aumento. El desarrollo de un colangioscopio de un único operador y desechable ha permitido expandir la técnica entre buena parte de los hospitales que realizan CPRE. Por este motivo, la Sociedad Española de Endoscopia Digestiva ha desarrollado este documento de consenso sobre la utilización del colangioscopio Spyglass-DS. El documento ha sido elaborado por un grupo de endoscopistas expertos en colangioscopia, revisando la evidencia científica de las principales indicaciones actuales de la colangiopancreatoscopia.(AU)

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.(AU)

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.

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 (AU)

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.

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.

Endoscopic ultrasound-guided fine-needle biopsy in patients with unexplained diffuse gastrointestinal wall thickening.

Background and study aims Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is recommended after non-diagnostic biopsy in gastrointestinal wall thickening, although the performance of currently available FNB needles in this setting is unknown. We aimed to assess the diagnostic accuracy and safety of EUS-FNB and to evaluate the "T" wall staging in malignant pathology. Patients and methods This was a single center retrospective study that included all consecutive patients undergoing EUS-FNB for diffuse gastrointestinal wall thickening with at least one previous negative conventional endoscopic biopsy between January 2016 and November 2019. EUS-FNB was performed using linear-array echoendoscopes with slow-pull/fanning technique. Tissue acquisition was done with 19- or 22-gauge biopsy needles. Samples were included in formalin without rapid on-site evaluation and submitted for histopathological processing. The final diagnosis was based on conclusive histology or absence of evidence of disease progression after follow-up at least 6 months. Results Twenty-nine patients (21 men), with a median age of 68 (IQR: 56-77), were included. EUS-FNB was technically feasible and the sample quality was adequate for full histological assessment in all patients (100 %). Sensitivity, specificity, positive and negative predictive values, and overall accuracy for diagnosis of malignancy were 95.5 %, 100 %, 100 %, 83.3 %, and 96.3 %, respectively. In patients with malignant disease, the samples obtained allowed detection of signs of deep layer infiltration ("histological staging") in 17 of 21 cases (81 %). No adverse events were noted. Conclusions The EUS-FNB technique demonstrated excellent diagnostic performance and safety in the study of unexplained diffuse gastrointestinal wall thickening. Histological staging was obtained in a high percentage of samples.

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.

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.

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.