Comparison of EUS-guided choledochoduodenostomy and percutaneous drainage for distal biliary obstruction: A multicenter cohort study.

Background and Objectives: Percutaneous transhepatic biliary drainage (PTBD) and EUS-guided choledochoduodenostomy (EUS-CD) are alternate therapies to endoscopic retrograde cholangiopancreatography with stent placement for biliary decompression. The primary outcome of this study is to compare the technical and clinical success of PTBD to EUS-CD in patients with distal biliary obstruction. Secondary outcomes were adverse events (AEs), need for reintervention, and survival. Methods: A multicenter retrospective cohort study from three different centers was performed. Cox regression was used to compare time to reintervention and survival and logistic regression to compare technical and clinical success and AE rates. Subgroup analysis was performed in patients with malignant biliary obstruction (MBO). Results: A total of 86 patients (58 PTBD and 28 EUS-CD) were included. The two groups were similar with respect to age, gender, and cause of biliary obstruction, with malignancy being the most common etiology (80.2%). EUS-CD utilized lumen-apposing metal stents in 15 patients and self-expandable metal biliary stents in 13 patients. Technical success was similar been EUS-CD (100%) and PTBD (96.6%; P = 0.3). EUS-CD was associated with higher clinical success compared to PTBD (84.6% vs. 62.1%; P = 0.04). There was a trend toward lower rates of AEs with EUS-CD 14.3% versus PTBD 29.3%, odds ratio: 0.40 (95% confidence interval [CI]: 0.12-1.33, P = 0.14). The need for reintervention was significantly lower among patients who underwent EUS-CD (10.7%) compared to PTBD (77.6%) (hazard ratio: 0.07, 95% CI: 0.02-0.24; P < 0.001). A sensitivity analysis of only patients with MBO demonstrated similar rate of reintervention between the groups in individuals who survived 50 days or less after the biliary decompression. However, reintervention rates were lower for EUS-CD in those with longer survival. Conclusion: EUS-CD is a technically and clinically highly successful procedure with a trend toward lower AEs compared to PTBD. EUS-CD minimizes the need for reintervention, which may enhance end-of-life quality in patients with MBO and expected survival longer than 50 days.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

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.

Endoscopic sleeve gastroplasty: suturing the gastric fundus does not confer benefit.

BACKGROUND : There is heterogeneity regarding the technical aspects of endoscopic sleeve gastroplasty (ESG), such as applying fundal sutures. Our aim was to determine whether ESG with fundal suturing (ESG-FS) affects weight loss and the serious adverse event (SAE) rate when compared with ESG with no fundal suturing (ESG-NFS). METHODS: We conducted a two-center retrospective analysis of 247 patients who underwent ESG with or without fundal suturing. The primary outcome was percentage excess weight loss (%EWL) at 3, 6, and 12 months post-ESG. The secondary outcomes included the SAE rate and procedure duration. RESULTS: At 3, 6, and 12-months, ESG-NFS had a significantly greater mean %EWL compared with ESG-FS (38.4 % [standard deviation (SD) 15.3 %] vs. 31.2 % [SD 13.9 %], P = 0.001; 54.7 % [SD 19.2 %] vs. 37.7 % [SD 17.3 %], P < 0.001; 65.3 % [SD 21.1 %] vs. 40.6 % [SD 23.5 %], P < 0.001, respectively). There was no statistically significant difference in the SAE rates for ESG-NFS (n = 2; 2.0 %) and ESG-FS (n = 4; 2.6 %; P > 0.99). The mean procedure time was significantly shorter in the ESG-NFS group at 59.1 minutes (SD 32.7) vs. 93.0 minutes (35.5; P < 0.001), and a lower mean number of sutures were used, with 5.7 (SD 1.1) vs. 8.4 (SD 1.6; P < 0.001). CONCLUSION : ESG-NFS demonstrated greater efficacy and shorter procedure duration. Therefore, fundal suturing should not be performed.

Endoscopic endgame for obstructive pancreatopathy: outcomes of anterograde EUS-guided pancreatic duct drainage. A dual-center study.

BACKGROUND AND AIMS: Anterograde endoscopic ultrasound-guided pancreatic duct drainage (EUS-PDD) refers to transmural drainage of the main pancreatic duct via an endoprosthesis passed anterograde through the gastric (or intestinal) wall. Anterograde EUS-PDD is a rescue procedure for recalcitrant cases of benign obstructive pancreatopathy. METHODS: We conducted a dual-center retrospective chart review of 28 patients (mean age, 59 years; 50% female) who underwent attempted anterograde EUS-PDD between April 2016 and September 2019 for chronic pancreatitis (CP) (93%) or pancreaticojejunostomy stenosis (PJS) after Whipple resection (7%). The study endpoint was achievement of transpapillary/transanastomotic drainage (definitive therapy). RESULTS: Gastropancreaticoenterostomy (ring drainage, definitive therapy) was successfully performed during the index procedure in the 2 patients with PJS (technical success, 100%). Clinical success was 100% in the 2 ring drainage recipients during a mean 18-month follow-up period. The remaining 26 patients with CP underwent attempted pancreaticogastrostomy (PG) with 81% technical success, 75% clinical success, and 15% adverse events (AEs). Repeat endoscopic transmural interventions were performed in the 15 patients with clinical success after PG creation. Definitive therapy transpired in all 15 patients after a median 1 repeat procedure per patient. Clinical success after definitive therapy was maintained in all 15 patients (100%) during a median 4.5-month follow-up. CONCLUSIONS: In agreement with previous studies, our study showed mild to moderately high rates of technical failure (19%), clinical failure (25%), and AEs (15%) during index drainage (PG creation). Among patients with CP with both technical and clinical success after index PG creation (n = 15), 100% definitive therapy was achieved and clinical outcomes were excellent (100% clinical success, 0% AEs).

Endoscopic ultrasound-guided drainage of pancreatic walled-off necrosis using 20-mm versus 15-mm lumen-apposing metal stents: an international, multicenter, case-matched study.

BACKGROUNDS: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events. METHODS: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria). RESULTS: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P = 0.72) and bleeding events (4.9 % vs. 3.4 %; P = 0.54) between the 20-mm and 15-mm LAMS groups, respectively. CONCLUSIONS: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution.

EUS-directed transenteric ERCP in non-Roux-en-Y gastric bypass surgical anatomy patients (with video).

BACKGROUND AND AIMS: Enteroscopy-assisted ERCP is challenging in patients with surgically altered upper GI anatomy. This study evaluated a novel procedure, EUS-directed transenteric ERCP (EDEE), in the de novo creation of an enteroenteric anastomosis for the performance of ERCP in non-Roux-en Y gastric bypass (RYGB) patients. METHODS: This was a multicenter retrospective study involving 7 centers between January 2014 and October 2018. Primary outcome was clinical success (completion of EDEE and ERCP with intended interventions), and secondary outcomes were technical success and rate/severity of adverse events. RESULTS: Eighteen patients (mean age, 63 years; 13 women) were included. The most common type of surgical anatomy was Whipple (10/18) and Roux-en-Y hepaticojejunostomy (6/18). Technical success rate of EUS-guided lumen-apposing metal stent (LAMS) placement was 100% and of ERCP was 94.44% (17/18). Fourteen patients underwent separate-session EDEE with a median of 21 days (interquartile range [IQR], 11.5-36) between the 2 procedures. Median total procedure time was 111 minutes (IQR, 81-192). Clinical success and adverse events occurred in 17 (94.4%) and 1 (5.6%; abdominal pain) patients, respectively, during a median follow-up of 88 days (IQR, 54-142). CONCLUSIONS: This study suggests that EDEE using LAMSs is feasible and safe in patients with non-RYGB surgical anatomy and complex pancreaticobiliary pathologies.

Endoscopic Sleeve Gastroplasty Is Feasible, Safe, and Effective in a Non-academic Setting: Short-Term Outcomes from a Community Gastroenterology Practice.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) has demonstrated promising weight loss results with fewer adverse events and less new-onset gastroesophageal reflux disease (GERD) compared to laparoscopic sleeve gastrectomy. Publications on ESG have exclusively described the experience at large academic medical centers with little known about the implementation and outcomes of this procedure in community practice. METHODS: We conducted a retrospective study of consecutive patients who underwent ESG at a private, community-based gastroenterology practice. Total body weight loss (TBWL), procedure duration, improvement in metabolic comorbidities, and adverse event (AE) rate and severity were assessed. RESULTS: One hundred patients underwent ESG (86 women, mean age 45 ± 9 years) and were analyzed. Procedure duration was 59 ± 33 min with an improvement in procedural efficiency from the first quartile (mean 105 min) to the fourth quartile (mean 38 min). Mean 12-month TBWL was 29.80 ± 11.46 kg (23.1 ± 7.5%), with excess weight loss of 66.1 ± 21.5%. Over this time period, mean change in BMI was 9.43 ± 0.22. A multiple linear regression model found that higher starting weight (P < 0.05) and absence of suture reinforcement (P = 0.037) were associated with increased TBWL at 3 months. Fourteen of 20 cases of hypertension, and 5 of 10 cases of dyslipidemia, were in complete remission by post-procedure month 3. CONCLUSIONS: ESG performed in a community gastroenterology practice demonstrated comparable clinical outcomes to large tertiary referral centers. TBWL and excess body weight loss either met or exceeded previously reported data from these centers.

EUS-guided gastroenteric anastomosis as a bridge to definitive treatment in benign gastric outlet obstruction.

BACKGROUND AND AIMS: Benign gastric outlet obstruction (GOO) has typically been managed surgically. However, many patients are poor operative candidates because of comorbidities. EUS-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) has previously demonstrated efficacy as a definitive treatment for benign and malignant GOO; however, limited data exist on use as a bridge to resolution of the obstruction in an attempt to avoid or delay definitive surgery. METHODS: A retrospective series of consecutive patients who underwent EUS-GE between January 2013 and July 2019 for benign GOO at a tertiary referral center were included in the study. The primary outcome was the rate of definitive surgery; secondary outcomes included technical success and rate of adverse events. RESULTS: During the study period, 22 patients with benign GOO underwent EUS-GE (40% female; mean age, 54.2 years). The mean procedure time was 66 minutes, and technical success was achieved in 21. Five patients developed recurrent GOO while the LAMS was in place after a mean dwell time of 228 days; 1 patient was converted to surgical GE. LAMSs were removed electively in 18 patients after GOO resolution and a mean dwell time of 270 days; 1 patient developed a recurrent GOO after LAMS removal and was converted to surgical GE. The rate of recurrent GOO after LAMS removal was 5.6%. Three severe adverse events occurred in the cohort. CONCLUSIONS: EUS-GE was able to prevent surgery for GOO in 83.3% of cases. LAMSs needed to stay in place for a mean of 8.5 months to allow resolution of GOO, and there was a low rate of recurrent GOO (5.6%) after LAMS removal. Prospective, randomized trials comparing surgical and endoscopic anastomoses are needed in patients with benign causes of GOO.