Feasibility and safety of peroral endoscopic myotomy with fundoplication in patients with achalasia: a systematic review and meta-analysis.

Background: Achalasia can cause disabling symptoms that may substantially impair the quality of life. Peroral endoscopic myotomy (POEM) has shown promising results in the management of achalasia. In this meta-analysis we have evaluated the feasibility and safety of single-session POEM with fundoplication (POEM+F) in patients with achalasia. Methods: We reviewed several databases from inception to July 08, 2022, to identify studies evaluating the feasibility and/or safety of single-session POEM+F for patients with achalasia. Our outcomes of interest included the technical success of POEM+F, adverse events, esophagitis and wrap integrity on follow-up upper endoscopy, total procedure time, and fundoplication time. Pooled rates with 95% confidence intervals (CI) for outcomes were calculated using a random effect model. Heterogeneity was assessed using the I 2 statistic. Results: We included 4 studies with 90 patients. Pooled rates (95%CI) of technical success and adverse events were 92% (83-96%) and 5% (2-11%), respectively. Pooled rates (95%CI) of esophagitis and wrap integrity on follow-up upper endoscopy were 18% (11-30%) and 85% (43-98%) respectively. Pooled mean procedure time and fundoplication time were 113.2 (98.7-127.6) and 55.3 (43.7-66.8) min, respectively. Conclusions: This meta-analysis demonstrates the feasibility and safety of POEM+F in patients with achalasia. More studies with long-term follow up are required to further validate these findings.

Comprehensive analysis of adverse events associated with transmural use of LAMS in patients with liver cirrhosis: International multicenter study.

Background and study aims Endoscopic ultrasound (EUS)-guided transmural (TM) deployment of lumen-apposing metal stents (LAMS) is considered relatively safe in non-cirrhotic patients and is cautiously offered to cirrhotic patients. Patients and methods This was a retrospective, multicenter, international matched case-control study to study the safety of EUS-guided TM deployment of LAMS in cirrhotic patients. Results Forty-three cirrhotic patients with model for end-stage liver disease score 12.5 ± 5, with 23 having ascites and 16 with varices underwent EUS-guided TM LAMS deployment, including 19 for pancreatic fluid collection (PFC) drainage, 13 gallbladder drainage, six for endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP), three for EDGI, one for endoscopic ultrasound-directed transenteric ERCP, and one postsurgical collection drainage. Technical failure occurred in one LAMS for PFC drainage. Clinical failure was encountered in another PFC. Nine adverse events (AEs) occurred. The most common AE was LAMS migration (3), followed by non-bleeding mucosal erosion (2), delayed bleeding (2), sepsis (1), and anesthesia-related complication (pulseless electrical activity) (1). Most AEs were graded as mild (6), followed by severe (2), and moderate (1); the majority were managed conservatively. On univariable comparison, risk of AE was higher when using a 20 × 10 mm LAMS and the absence of through-the-LAMS plastic stent(s). Conditional logistic regression of matched case-control patients did not show any association between potential predicting factors and occurrence of AEs. Conclusions Our study demonstrated that mainly in patients with Child-Pugh scores A and B cirrhosis and despite the presence of mild-to-moderate ascites in over half of cases, the majority of AEs were mild and could be managed conservatively. Further studies are warranted to verify the safety of LAMS in cirrhotic patients.

Safety, Efficacy and Clinical Utility of the 5.1mm EndoRotor Powered Debridement Catheter for Treatment of Walled-Off Pancreatic Necrosis.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) is a recommended strategy for treatment of walled-off-necrosis (WON). DEN uses a variety of devices including the EndoRotor (Interscope, Inc.) debridement catheter. Recently, a 5.1 mm EndoRotor with increased chamber size and rate of tissue removal was introduced. The aim of this study was to assess the efficacy and safety of this device. METHODS: A multi-center cohort study was conducted at eight institutions including patients who underwent DEN with the 5.1 mm EndoRotor. The primary outcome was the number of DEN sessions needed for WON resolution. Secondary outcomes included the average percent reduction in solid WON debris and decrease in WON area per session, total time spent performing EndoRotor therapy for WON resolution, and adverse events. RESULTS: 64 procedures in 41 patients were included. For patients in which the 5.1 mm EndoRotor catheter was the sole therapeutic modality, an average of 1.6 DEN sessions resulted in WON resolution with an average cumulative time of 85.5 minutes. Of the 21 procedures with data regarding percent of solid debris, the average reduction was 85% +/- 23% per session. Of the 19 procedures with data regarding WON area, the mean area significantly decreased from 97.6 +/- 72.0 cm2 to 27.1 +/- 35.5 cm2 (p<0.001) per session. Adverse events included two intra-procedural LAMS dislodgements managed endoscopically and three perforations none of which were related to EndoRotor. Bleeding was reported in seven cases, none required embolic or surgical therapy and two required blood transfusions. CONCLUSIONS: This is the first multi-center retrospective study to investigate the efficacy and safety of the 5.1 mm EndoRotor catheter for WON. Results from this study showed an average of 1.6 DEN sessions were needed to achieve WON resolution with an 85% single session reduction in solid debris and a 70% single session decrease in WON area with minimal adverse events.

Colonic-enteric lumen-apposing metal stents: a promising and safe alternative for endoscopic management of small-bowel obstruction.

BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) have revolutionized the treatment of various gastroenterologic conditions that previously required surgery. The use of LAMSs for the management of small-bowel obstruction (SBO) involves EUS-guided coloenterostomy (EUS-CE) between the colon and a dilated loop of the small intestine proximal to the point of obstruction. This procedure is potentially beneficial for patients with malignant SBO who are poor surgical candidates. METHODS: A retrospective cohort study was conducted at 2 tertiary care hospitals. Patients who underwent EUS-CE for SBO were identified, and data regarding patient demographics, indication for the procedure, location of the obstruction, procedural details, and adverse events were collected. The primary outcome was technical success of the procedure. Secondary outcomes were clinical success, resolution of symptoms, ability to tolerate enteral nutrition, and adverse events. RESULTS: Twenty-six patients who underwent the EUS-CE procedure were included. Technical success was achieved in all 26 patients, clinical success (resolution of obstructive symptoms) was achieved in 92.3% of patients (24/26), and the ability to resume enteral nutrition in 84.6% (22/26). Adverse events occurred in 4 patients (15.4%) and included bleeding (1/26), diarrhea (2/26), and postprocedure sepsis (1/26). Patients were followed for a mean of 54.8 days (range, 2-190). CONCLUSIONS: This study highlights that EUS-CE with LAMSs can be performed with high technical and clinical success for the management of SBO, particularly in patients with malignant obstructions who are not suitable candidates for surgical interventions. Further research with larger sample sizes will be essential to substantiate its efficacy and safety.

Randomized trial of gastric and colorectal endoscopic submucosal dissection defect closure comparing a novel through-the-scope suturing system with an over-the-scope suturing system (with video).

BACKGROUND AND AIMS: Mucosal closure adds time but reduces adverse events associated with endoscopic submucosal dissection (ESD). We aimed to assess the closure time (CT), technical success, and cost-effectiveness between a novel through-the-scope helix tack suture system (TTSS) and the over-the-scope suturing system (OTSS). METHODS: In this single-center, prospective, randomized trial, all patients undergoing ESD with anticipated closure were randomized 1:1 to TTSS (study group) or OTSS (control group). Primary outcomes were CT and overall CT (OCT; CT + setup time). Secondary outcomes were rates of technical success, adverse events, and cost-effectiveness. RESULTS: Forty patients were randomized to OTSS (n = 20) or TTSS (n = 20). OTSS and TTSS groups were similar with respect to age, gender, proportion of colorectal polyps, proximal colon polyps, and mean size of the resected specimen (40.9 mm vs 40.4 mm). The mean CT was 18.4 minutes for OTSS and 23.3 minutes for TTSS (P = .36). The mean OCT was 32 minutes for OTSS and 39.5 minutes for TTSS (P = .36). Closure with a primary device was successful in 17 cases (85%) with OTSS and 18 cases (90%) with TTSS (P = .63). No closure-related intraprocedural adverse events or delayed perforations were noted. Mean cost of closure was significantly lower in the TTSS group for lesions <35 mm (P = .008). CONCLUSIONS: TTSS was not found to be superior to OTSS with respect to CT and technical and clinical success for closure of gastric and colorectal ESD defects. TTSS is more cost-effective for closure of lesions <35 mm. (Clinical trial registration number: NCT04925271.).

Clip Dislodgement After Full-Thickness Endoscopic Resection Device Removal of Scarred Gastric Subepithelial Lesion Leading to Delayed Perforation.

Endoscopic full-thickness resection using a full-thickness resection device is a newer technique for endoscopic removal of submucosal lesions not amenable to endoscopic mucosal resection or endoscopic submucosal dissection. There is a low rate of complications reported, although we report 2 cases of delayed perforation caused by dislodgement of a full-thickness resection device clip after removal of scarred gastric lesions. Both were managed endoscopically with good outcomes. However, special attention and consideration of alternative closure techniques should be considered with scarred gastric lesions and possible changes to the clip design could be considered.

Identification of sentinel lymph nodes in esophageal cancer patients using contrast-enhanced EUS with peritumoral injections.

Objectives: The objective of this pilot study was to compare the performance of contrast-enhanced EUS (CE-EUS)-guided fine-needle aspiration (FNA) with EUS-FNA for lymph node (LN) staging in esophageal cancer. Methods: Thirty-seven subjects with esophageal cancer undergoing EUS staging were enrolled, and 30 completed this institutional review board-approved study. A Prosound F75 US system (Hitachi Medical Systems, Tokyo, Japan) with harmonic contrast imaging software and GF-UCT180 curvilinear endoscope (Olympus, Tokyo, Japan) was utilized. All LNs identified by standard EUS were first noted. Sonazoid (dose: 1 mL; GE Healthcare, Oslo, Norway) was administered peritumorally, and all enhanced LNs were recorded. Fine-needle aspiration was performed on LNs considered suspicious by EUS alone, as well as LNs enhanced on CE-EUS. Performance of each modality was compared using FNA cytology as reference standard. Results: A total of 132 LNs were detected with EUS, of which 59 showed enhancement on CE-EUS. Fifty-three LNs underwent FNA, and 22 LNs were determined to be malignant. Among the latter, 10 were considered suspicious by EUS, whereas the other 12 LNs underwent FNA only because of CE-EUS enhancement. Contrast-enhanced EUS showed enhancement in 19 of the 22 malignant LNs. The rate of metastatic node identification from EUS was 45% (10/22), and it was 86% (19/22; P = 0.008) for CE-EUS. Eight subjects (8/30 [27% of study total]) had nodal status upgraded by the addition of CE-EUS, which influenced LN staging and clinical management. Conclusions: Fine-needle aspiration of LNs identified by CE-EUS may increase metastasis positive rate by ruling out LNs not associated with the tumor drainage pattern. In addition, CE-EUS seems to identify more metastatic LNs that would not be biopsied under the standard EUS criteria.

EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Cold snare versus cold forceps polypectomy for endoscopic resection of diminutive polyps: meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: The practices for resection of diminutive colon polyps vary among endoscopists, and U.S. Multi-Society Task force guidelines recommend use of cold snare polypectomy (CSP) for this purpose. In this meta-analysis, we compared CSP and cold forceps polypectomy (CFP) for resection of diminutive polyps. METHODS: Several databases were reviewed to identify randomized controlled trials that compared CSP and CFP for resection of diminutive polyps. The study outcomes of interest were complete resection of all diminutive polyps, complete resection of polyps ≤3 mm in size, failure of tissue retrieval, and polypectomy time. For categorical variables, pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated; for continuous variables, mean differences (MDs) with 95% CIs were calculated. Data were analyzed by using a random-effects model, and heterogeneity was assessed by using the I2 statistic. RESULTS: We included 9 studies with 1037 patients. Rate of complete resection of all diminutive polyps was significantly higher in the CSP group (OR, 1.68; 95% CI, 1.09-2.58). Subgroup analysis, including jumbo or large-capacity forceps, found no significant difference in complete resection between groups (OR, 1.43; 95% CI, .80-2.56). We found no significant between-groups in the rates of complete resection of polyps ≤3 mm in size (OR, .83; 95% CI, .30-2.31). Rate of failure of tissue retrieval was significantly higher in the CSP group (OR, 10.13; 95% CI, 2.29-44.74). No significant between-group difference was noted in polypectomy time. CONCLUSIONS: CFP using large-capacity or jumbo biopsy forceps is noninferior to CSP for complete resection of diminutive polyps.

Electrocautery-enhanced Lumen-apposing Metal Stents in the Management of Symptomatic Pancreatic Fluid Collections: Results From the Multicenter Prospective Pivotal Trial.

BACKGROUND AND AIMS: Endoscopic decompression is considered a first-line treatment for symptomatic pancreatic fluid collections (PFCs). A lumen-apposing metal stent (LAMS) with an electrocautery-enhanced delivery system [electrocautery-enhanced lumen-apposing metal stent (ELAMS)] may facilitate this procedure. This study evaluated the safety and efficacy of ELAMS in the management of symptomatic PFCs. PATIENTS AND METHODS: A multicenter, nonblinded, prospective, Food and Drug Administration (FDA)-approved, investigational device exemption clinical trial was conducted. Enrollment criteria included symptomatic PFCs ≥6 cm with ≥70% fluid fraction. Subjects were followed prospectively for safety, efficacy, and resolution of the collections. Primary endpoint success was defined as ≥50% reduction in PFC size. Clinical outcomes were compared with our previously published series of LAMS without the cautery-enhanced delivery system. RESULTS: The target enrollment of 30 patients was achieved in 7 US tertiary care centers. All patients underwent successful placement of the ELAMS. The mean procedure duration, stent placement time, and fluoroscopy exposures were 28.1±12.5, 5.8±2.6, and 1.8±1.6 minutes, respectively. Eight patients had no fluoroscopy. The primary endpoint was achieved in 83.3% of patients. Two adverse events were attributed to the ELAMS: 1 bleeding upon stent removal and 1 stent migration. Relative to the comparator noncautery LAMS multicenter trial (N=33, 8 tertiary centers), there was a significantly shorter procedure duration [36 min ( P <0.001)] with similar technical and clinical outcomes in the ELAMS cohort. CONCLUSION: LAMS placed using an electrocautery delivery system significantly reduce procedure duration and were safe and effective in the management of symptomatic PFCs.

Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study.

INTRODUCTION: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. METHODS: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. RESULTS: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. CONCLUSIONS: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.

Prediction and management of bleeding during endoscopic necrosectomy for pancreatic walled-off necrosis: results of a large retrospective cohort at a tertiary referral center.

BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) provide an endoscopic method for management of walled-off necrosis (WON) and a gateway for the performance of endoscopic necrosectomy (EN). However, bleeding may occur in up to 20% of EN procedures. Predictive factors for bleeding in this patient population are unknown, and there is no agreed-on algorithm for the management of bleeding. The aim of this study was to evaluate preprocedural risk factors for bleeding in patients undergoing endoscopic drainage or EN for WON. METHODS: A retrospective cohort of patients undergoing EN for WON was reviewed. Demographics, comorbidities, concurrent medications, and etiology of pancreatitis were recorded. Pre-, peri-, and postprocedural clinical variables were compared using the χ2 test and independent t test. RESULTS: Between June 2014 and October 2020, 536 ENs were performed in 151 patients. Intraprocedural bleeding occurred during 28 procedures (5.2%) in 18 patients (11.9%). Endoscopic hemostasis was attempted in 8 patients (10 procedures). Eight patients (10 procedures) in total were treated by interventional radiology (IR). Thrombocytopenia (P = .006) and cirrhosis (P = .049) were associated with intraprocedural bleeding, although thrombocytopenia was present in only 1 patient. Identification of a vessel within the cavity endoscopically was also associated with bleeding (P < .001). On multivariate analysis, identification of a vessel within the cavity endoscopically remained a strong predictor of bleeding (P < .001), whereas cirrhosis was no longer significant. Patients who required IR for hemostasis were transfused with significantly more blood before the procedure than patients who did not (3.4 units vs .67 units, P = .002). CONCLUSIONS: EN for WON was associated with a 5.2% per-procedure risk of bleeding and an 11.9% per-patient bleeding risk. Identification of a vessel within the cavity during endoscopy is predictive of bleeding during EN. Patients who require more transfusions before endoscopy may require earlier intervention by IR.

Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).

Accuracy of cytopathology evaluation for resected benign and malignant pancreatic disease.

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the preferred method for diagnosing pancreatic masses. While the diagnostic success of EUS-FNA is widely accepted, the actual performance of EUS-FNA is not known. This study sought to define the EUS-FNA accuracy compared with the gold standard, surgically resected specimens. The study was a single institution, retrospective, and chart review of patients with surgically resected pancreatic specimens from 2005 to 2015 with a preoperative EUS-FNA or biliary brushing. Cytological reports were organized from least concerning (i.e., low chance of malignancy) to most concerning (high chance of malignancy) into eight cytologic categories. We identified 741 cytologic cases: 530 EUS-FNA and 211 endoscopic brushings. For EUS-FNA samples, 62.5% of "benign" samples proved to be "benign" on surgical pathology. A cytologic diagnosis of "suspicious for malignancy" or "positive for malignancy" were concordant with a cancer diagnosis on surgical pathology 93.3% and 98.0% of cases, respectively. EUS-FNA proved to be highly reliable at diagnosing malignancy for cytologic samples that were "suspicious" or "positive" for malignancy. Paired with supportive clinical data, these interpretations may be used to justify cancer treatment.

Maximizing success in single-session EUS-directed transgastric ERCP: a retrospective cohort study to identify predictive factors of stent migration.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (the EDGE procedure) is a simplified method of performing ERCP in Roux-en-Y gastric bypass patients. The EDGE procedure involves placement of a lumen-apposing metal stent (LAMS) into the excluded stomach to serve as a conduit for passage of the duodenoscope for pancreatobiliary intervention. Originally a multistep process, urgent indications for ERCP have led to the development of single-session EDGE (SS-EDGE) with LAMS placement and ERCP performed in the same session. The goal of this study was to identify predictive factors of intraprocedural LAMS migration in SS-EDGE. METHODS: We conducted a multicenter retrospective review that included 9 tertiary medical centers across the United States. Data were collected and analyzed from 128 SS-EDGE procedures. The primary outcome was intraprocedural LAMS migration. Secondary outcomes were other procedural adverse events such as bleeding and perforation. RESULTS: Eleven LAMS migrations were observed in 128 procedures (8.6%). Univariate analysis of clinically relevant variables was performed, as was a binary logistic regression analysis of stent diameter and stent dilation. This revealed that use of a smaller (15 mm) diameter LAMS was an independent predictor of intraprocedural stent migration (odds ratio, 5.36; 95% confidence interval, 1.29-22.24; P = .021). Adverse events included 3 patients who required surgery and 2 who experienced intraprocedural bleeding. CONCLUSIONS: Use of a larger-diameter LAMS is a predictive factor for a nonmigrated stent and improved procedural success in SS-EDGE. Although larger patient cohorts are needed to adequately assess these findings, performance of LAMS dilation and fixation may also decrease risk of intraprocedural LAMS migration and improve procedural success.

International, multicenter retrospective trial comparing the efficacy and safety of bi-flanged versus lumen-apposing metal stents for endoscopic drainage of walled-off pancreatic necrosis.

BACKGROUND: To compare fully covered bi-flanged metal stents (BFMS) and lumen-apposing metal stents (LAMS) for endoscopic ultrasound (EUS)-guided drainage/debridement of pancreatic walled-off necrosis (WON). METHODS: Patients with WON managed by EUS-guided therapy were divided into those who underwent: 1) drainage using BFMS; and 2) drainage using LAMS and scheduled direct endoscopic necrosectomy (DEN). Clinical success (resolution of the WON), technical success (successful stent placement), and adverse events (AEs) were evaluated. RESULTS: 387 patients underwent WON endoscopic drainage, 205 using BFMS and 182 using LAMS. The clinical success in the BFMS or LAMS groups were similar (197 [96.1%] vs. 174 [95.6%]; P=0.81). Median number of procedures required for WON resolution was significantly lower in BFMS compared to LAMS (2 vs. 3, P<0.001). Technical success for stent placement was similar in BFMS and LAMS groups (203 [99%] vs. 180 [99%], P=0.90). Procedure-related AEs were similar in the BFMS and LAMS groups (19 [9.3%] vs. 20 [10.9%], P=0.61). Stent dysfunction with occluding debris was higher in the BFMS group compared to LAMS group (21 [10.2 %] vs. 11 [5.9%], P=0.04). The migration rate was higher in the BFMS group than in the LAMS group (15 [7.3%] vs. 3 [1.6%]; P<0.001). DEN was required in 23 [11.2%] patients in the BFMS group after lack of WON resolution by conservative means. CONCLUSION: BFMS with a "step-up approach" and LAMS with scheduled DEN are both safe and effective for EUS-guided drainage/debridement of WON.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study.

BACKGROUND: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. METHODS: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. RESULTS: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Unilateral versus bilateral hilar stents for the treatment of cholangiocarcinoma: a multicenter international study.

BACKGROUND: Endoscopic placement of hilar stents is an accepted palliative therapy for patients with advanced, unresectable cholangiocarcinoma. However, whether unilateral versus bilateral stent placement provides optimal relief continues to be a subject of debate. The aim of this study was to compare the technical and clinical outcomes in patients with inoperable cholangiocarcinoma who received unilateral or bilateral self-expanding metal stents (SEMS). METHODS: We conducted a multicenter, international retrospective study of 187 patients with cholangiocarcinoma who received unilateral or bilateral SEMS. Outcomes included, but were not limited to, technical success, clinical success, adverse events, stent occlusion, and survival time. Results were further stratified based on the Bismuth classification. RESULTS: Fifty patients received unilateral stents and 137 patients received bilateral stents. All patients achieved technical success. The clinical success rates were 86% for unilateral stents and 82.5% for bilateral stents (P>0.99). Clinical success was not statistically different for either group when stratified by the Bismuth classification (P=0.62 and P=0.72 respectively). There were significantly more adverse events in the bilateral stents group (11.7% vs. 0%, P=0.007). There was no greater risk of stent occlusion when bilateral stents were used (unadjusted P=0.71, adjusted P=0.81). There was a greater risk of death for patients who received bilateral SEMS (hazard ratio 1.78, 95% confidence interval 1.09-2.89; P=0.02). CONCLUSIONS: Unilateral and bilateral drainage had similar technical and clinical success rates. However, bilateral stents had a higher risk of death and more adverse events. Therefore, unilateral SEMS placement is sufficient for relief of biliary obstruction secondary to cholangiocarcinoma.