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 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 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.

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.

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).

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 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.

Efficacy of Endoscopic Dilation of Gastroduodenal Crohn's Disease Strictures: A Systematic Review and Meta-Analysis of Individual Patient Data.

BACKGROUND & AIMS: Little is known about the effects of endoscopic balloon dilation (EBD) for strictures of the upper gastrointestinal (UGI) tract in patients with Crohn's disease (CD). We performed a pooled analysis of the efficacy and safety of EBD for UGI CD-associated strictures. METHODS: We searched Embase, Medline, and the Cochrane library, as well as bibliographies of relevant articles, for cohort studies of adults with CD and strictures of the stomach or duodenum (up to the ligament of Treitz) who underwent EBD through December 2016. We obtained data from 7 international referral centers on 94 patients who underwent 141 EBDs. We performed a patient-level meta-analysis of data from published and unpublished cohort studies to determine mechanical and clinical success. We performed a time-to-event analysis to assess symptom recurrence and need for redilation or surgery. The patients analyzed had strictures of the duodenum (n = 107), stomach (n = 30), or spanning both (n = 4). RESULTS: The rate of technical success for EBD was 100%, with 87% short-term clinical efficacy; major complications arose from 2.9% of all procedures. During a median follow-up period of 23.1 months, 70.5% of patients had a recurrence of symptoms, 59.6% required redilation, and 30.8% required surgical intervention. Patients whose disease was located in the small bowel had a higher risk for symptom recurrence (hazard ratio [HR], 2.1; P = .003). Asian race (HR, 2.8; P < .001) and location of disease in the small bowel (HR, 1.9; P = .004) increased the need for redilation. Prestenotic dilation was a risk factor for needing surgery earlier (HR, 1.9; P = .001). CONCLUSIONS: In a meta-analysis, we found EBD for CD-associated strictures of the UGI to be an effective alternative to surgery, with a high rate of short-term technical and clinical success, moderate long-term efficacy, and an acceptable rate of complications.

Cost-effectiveness of endoscopic ultrasound-directed transgastric ERCP compared with device-assisted and laparoscopic-assisted ERCP in patients with Roux-en-Y anatomy.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) surgery is the second most common weight loss surgery in the United States. Treatment of pancreaticobiliary disease in this patient population is challenging due to the altered anatomy, which limits the use of standard instruments and techniques. Both nonoperative and operative modalities are available to overcome these limitations, including device-assisted (DAE) endoscopic retrograde cholangiopancreatography (ERCP), laparoscopic-assisted (LA) ERCP, and endoscopic ultrasound-directed transgastric ERCP (EDGE). The aim of this study was to compare the cost-effectiveness of ERCP-based modalities for treatment of pancreaticobiliary diseases in post-RYGB patients. METHODS: A decision tree model with a 1-year time horizon was used to analyze the cost-effectiveness of EDGE, DAE-ERCP, and LA-ERCP in post-RYGB patients. Monte Carlo simulation was used to assess a plausible range of incremental cost-effectiveness ratios, net monetary benefit calculations, and a cost-effectiveness acceptability curve. One-way sensitivity analyses and probabilistic sensitivity analyses were also performed to assess how changes in key parameters affected model conclusions. RESULTS: EDGE resulted in the lowest total costs and highest total quality-adjusted life-years (QALY) for a total of $5188/QALY, making it the dominant alternative compared with DAE-ERCP and LA-ERCP. In probabilistic analyses, EDGE was the most cost-effective modality compared with LA-ERCP and DAE-ERCP in 94.4 % and 97.1 % of simulations, respectively. CONCLUSION: EDGE was the most cost-effective modality in post-RYGB anatomy for treatment of pancreaticobiliary diseases compared with DAE-ERCP and LA-ERCP. Sensitivity analysis demonstrated that this conclusion was robust to changes in important model parameters.

EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: First US, Multicenter Experience.

BACKGROUND AND AIMS: EUS-guided biliary drainage has emerged as a technique to enable endobiliary drainage in failed ERCP. A newer model, lumen-apposing metal stents (LAMS), with a cautery-enhanced delivery system became available in the USA in late 2015. This cautery-tipped version may facilitate EUS-guided choledochoduodenostomy (EUS-CD), but data using this model are lacking. METHODS: We reviewed outcomes of attempted EUS-CD using cautery-enhanced LAMS from 6, US centers. The following data were collected: patient and procedure details, technical success, adverse events, clinical success (resolution of jaundice or improvement in bilirubin > 50%), and biliary re-interventions. RESULTS: EUS-CD was attempted in 67 patients (mean age 68.8) with malignant obstruction after failed ERCP between September 2015 and April 2018. EUS-CD was technically successful in 64 (95.5%). A plastic or metal stent was inserted through the lumen of the deployed LAMS in 50 of 64 (78.1%) patients to maintain a non-perpendicular LAMS axis into the bile duct. Adverse events occurred in 4 (6.3%) and included: abdominal pain (n = 2), peritonitis that responded to antibiotics (n = 1), and bleeding requiring transfusion (n = 1). Among 40 patients with follow-up of > 4 weeks, clinical success was achieved in 100%. Biliary re-interventions for obstruction were needed in 7(17.5%), in 3 of 6 (50.0%) that underwent EUS-CD with LAMS alone versus 4 of 34 (5%) with LAMS plus an axis-orienting stent (p = 0.02). CONCLUSION: EUS-CD using LAMS with cautery-enhanced delivery systems has high technical and clinical success rates, with a low rate of adverse events. Inserting an axis-orienting stent through the lumen of the LAMS may reduce the need for biliary re-interventions.

Management of acute pancreatitis in the first 72 hours.

PURPOSE OF REVIEW: Acute pancreatitis is a common condition that affects patients with varying degrees of severity and may lead to significant morbidity and mortality. The present article will review the current paradigm in acute pancreatitis management within the first 72 h of diagnosis. RECENT FINDINGS: Patients presenting with acute pancreatitis should be evaluated clinically for signs and symptoms of organ failure in order to appropriately triage. Initial management should focus on fluid resuscitation, with some data to support Ringer's lactate over physiological saline. Routine use of prophylactic antibiotics in acute pancreatitis is not recommended, nor is urgent endoscopic retrograde cholangiopancreatography in the absence of concomitant acute cholangitis. Early oral feeding should be encouraged, not avoided, and use of parenteral nutrition is discouraged. Cholecystectomy during the same admission of biliary pancreatitis should be performed in order to prevent future acute pancreatitis episodes. Patients with acute pancreatitis secondary to alcohol should receive alcohol counseling. Finally, there is ongoing interest in the development of prognostic laboratory tests in acute pancreatitis and pharmacological therapies to reduce the inflammation that occurs in acute pancreatitis. SUMMARY: Acute pancreatitis is a common and heterogeneous condition with the potential for significant morbidity. Best practices in acute pancreatitis management focus on triage, hydration and enteral feeding.

EUS-guided hepaticoenterostomy as a portal to allow definitive antegrade treatment of benign biliary diseases in patients with surgically altered anatomy.

BACKGROUND AND AIMS: EUS-guided hepaticoenterostomy (EUS-HE) usually is reserved for palliation of malignant biliary obstruction after failed endoscopic retrograde cholangiography (ERC) or inaccessible biliary tree in surgically altered anatomy (SAA). We describe the outcome of EUS-HE and antegrade therapy for benign biliary disease in patients with SAA. METHODS: Retrospective review of 20 consecutive patients with surgically altered anatomy and benign biliary obstruction who underwent EUS-HE performed by 1 endoscopist at a tertiary-care center over a 3-year period. RESULTS: During the study period, 37 patients underwent EUS-HE; 24 for benign disease. Of these, 20 patients had SAA and were analyzed (15 women, mean age, 62 years). SAA consisted of 9 Roux-en-Y gastric bypasses, 6 Roux-en-Y hepaticojejunostomy, 2 Billroth II procedures, and 3 Whipple procedures. Indications for ERC were common bile duct stones (n = 8), benign postoperative strictures (n = 7), chronic pancreatitis (n = 3), inflammatory stricture (n = 1), and treatment of a bile leak (n = 1). Five patients had previously failed balloon enteroscopy-assisted ERCs. The approach was transgastric in 15 and transjejunal in 5. In all cases, a branch of the left hepatic duct with a mean diameter of 7.8 mm was accessed. Median stent length was 80 mm, with diameters of 8 or 10 mm. Antegrade, definitive endoscopic therapy via the HE was performed in 18 patients, with an average of 2.7 procedures performed for resolution of stones and/or downstream strictures. HE stents were removed in 17 patients after a mean of 91 days without adverse events. Three patients experienced mild adverse events (1 with postprocedural pancreatitis after placement of a 10F transpapillary stent, 1 with postprocedural abdominal pain, and 1 with postprocedural cholangitis) requiring hospitalization for fewer than 3 nights; no severe adverse events occurred. The average postprocedural hospital stay was 1.3 days. No deaths occurred during follow-up. CONCLUSIONS: EUS-HE is safe and effective in the management of benign biliary obstruction in patients with surgically altered anatomy. It creates a portal to allow definitive, antegrade therapy and is a viable alternative to other endoscopic methods in this patient population.

Ileus is a predictor of local infection in patients with acute necrotizing pancreatitis.

BACKGROUND & OBJECTIVES: Infected pancreatic necrosis (IPN) is associated with increased morbidity and mortality. Gut barrier dysfunction has been shown to increase the risk of bacterial translocation from the gut into the pancreatic bed. The primary aim of the study is to evaluate if ileus, a clinical marker of gut barrier dysfunction, can predict the development of IPN. METHODS: A retrospective cohort study of patients with necrotizing pancreatitis (NP) was conducted from 2000 to 2014. Ileus was defined as ≥2 of the following criteria: nausea/vomiting; inability to tolerate a diet, absence of flatus, abdominal distension and features of ileus on imaging. Extensive necrosis was defined as >30% nonenhancing pancreatic parenchyma on contrast-enhanced CT. Multivariable cox proportional hazard analysis was used to evaluate known and potential predictors of IPN. RESULTS: 142 patients were identified with NP, 61 with IPN and 81 with sterile necrosis. In comparison to a diagnosis of ileus documented in the medical chart, the ileus criteria had a sensitivity, specificity and positive and negative predictive value of 100%, 93%, 78% and 100%, respectively. On multivariate cox proportional hazard analysis, ileus [HR:2.6; 95%CI:1.4-4.9] and extensive necrosis [HR:2.8; 95%CI:1.3-5.8] were independently associated with the development of IPN while there was no association with bacteremia [HR:1.09; 95%CI:0.6-2.1]. CONCLUSION: Ileus in NP can be accurately defined using surgical criteria. Ileus is independently associated with the future development of IPN. Further studies will be needed to determine if ileus can serve as a clinical marker to direct therapeutic interventions aimed at reducing the incidence of IPN.