AGA Clinical Practice Update on Gastric Peroral Endoscopic Myotomy for Gastroparesis: Commentary.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding cognitive, procedural, and post-procedural aspects of performing gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors who are advanced endoscopists with expertise in treating patients by performing third-space endoscopy and gastric peroral endoscopic myotomy.

Development of a novel CT-based index for predicting the number of extracorporeal shockwave lithotripsy (ESWL) sessions required for successful fragmentation of obstructing pancreatic duct stones.

BACKGROUND & AIM: Extracorporeal shock wave lithotripsy (ESWL) is used for the treatment of pancreatic duct stones (PDS) in patients with chronic pancreatitis (CP). We aimed to develop a CT based index to predict the required number of ESWL sessions for technical success. METHODS: We retrospectively evaluated patients with PDS secondary to CP who underwent ESWL. Technical success was defined as the complete fragmentation of stones to <3 mm. CT features including PDS size, number, location, and density in Hounsfield units (HU) were noted. We analyzed the relationship between PDS characteristics and the number of ESWL sessions required for technical success. A multiple linear regression model was used to combine size and density into the pancreatic duct stone (PDS) index that was translated into a web-based calculator. RESULTS: There were 206 subjects (mean age 38.6 ± 13.7 years, 59.2% male) who underwent ESWL. PDS size showed a moderate correlation with the number of ESWL sessions (r = 0.42, p < 0.01). PDS in the head required a fewer number of sessions in comparison to those in the body (1.4 ± 0.6 vs. 1.6 ± 0.7, p = 0.01). There was a strong correlation between PDS density and the number of ESWL sessions (r = 0.617, p-value <0.01). The PDS index {0.3793 + [0.0009755 x PDS density (HU)] + [0.02549 x PDS size (mm)]} could accurately predict the required number of ESWL sessions with an AUC of 0.872 (p < 0.01). CONCLUSION: The PDS index is a useful predictor of the number of ESWL sessions needed for technical success that can help in planning and patient counseling.

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.

A machine learning-based choledocholithiasis prediction tool to improve ERCP decision making: a proof-of-concept study.

BACKGROUND: Previous studies demonstrated limited accuracy of existing guidelines for predicting choledocholithiasis, leading to overutilization of endoscopic retrograde cholangiopancreatography (ERCP). More accurate stratification may improve patient selection for ERCP and allow use of lower-risk modalities. METHODS: A machine learning model was developed using patient information from two published cohort studies that evaluated performance of guidelines in predicting choledocholithiasis. Prediction models were developed using the gradient boosting model (GBM) machine learning method. GBM performance was evaluated using 10-fold cross-validation and area under the receiver operating characteristic curve (AUC). Important predictors of choledocholithiasis were identified based on relative importance in the GBM. RESULTS: 1378 patients (mean age 43.3 years; 61.2% female) were included in the GBM and 59.4% had choledocholithiasis. Eight variables were identified as predictors of choledocholithiasis. The GBM had accuracy of 71.5% (SD 2.5%) (AUC 0.79 [SD 0.06]) and performed better than the 2019 American Society for Gastrointestinal Endoscopy (ASGE) guidelines (accuracy 62.4% [SD 2.6%]; AUC 0.63 [SD 0.03]) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines (accuracy 62.8% [SD 2.6%]; AUC 0.67 [SD 0.02]). The GBM correctly categorized 22% of patients directed to unnecessary ERCP by ASGE guidelines, and appropriately recommended as the next management step 48% of ERCPs incorrectly rejected by ESGE guidelines. CONCLUSIONS: A machine learning-based tool was created, providing real-time, personalized, objective probability of choledocholithiasis and ERCP recommendations. This more accurately directed ERCP use than existing ASGE and ESGE guidelines, and has the potential to reduce morbidity associated with ERCP or missed choledocholithiasis.

Interventional Endoscopic Ultrasound: Current Status and Future Frontiers.

Interventional endoscopic ultrasound has fueled remarkable advancements in the field of therapeutic procedures, revolutionizing minimally invasive interventions for a diverse range of conditions. This review highlights the latest breakthroughs and advancements in therapeutic endoscopic ultrasound, showcasing its potential to transform patient care.

Endoscopic approaches to small intestinal strictures.

PURPOSE OF REVIEW: Gastric outlet obstruction (GOO) occurs from benign or malignant causes. Historically, the treatment of benign strictures revolved around endoscopic balloon dilation, whereas, in the case of malignant strictures, the placement of self-expandable metallic stents was the focus. The advent of lumen-apposing metal stent has opened new horizons in addressing shortcomings of enteral stenting and surgical gastroenterostomies. The purpose of the review is to discuss the endoscopic approaches to small bowel strictures and to examine the supporting data behind each practice. RECENT FINDINGS: Given the risk and futility of balloon dilation for malignant strictures, enteral stenting is pursued in patients who are poor surgical candidates and with life expectancy less than 6 months. For patients with longer survival, surgical gastroenterostomy (S-GE) should be considered. Recent data have shown comparable technical and clinical success rates between EUS-gastroenterostomy and S-GE but with lower adverse event rate and hospital length of stay. SUMMARY: In recurrent benign strictures and malignant GOO, EUS-GE has recently gained momentum in providing an effective and a well tolerated alternative. Individualized therapy centered around the patient's prognosis and preference while factoring in the local expertise for the specific indication is vital.

Technical details and outcomes of peroral endoscopic myotomy with fundoplication: the first U.S. experience (with video).

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is an established endoscopic treatment for achalasia; however, post-POEM rates of GERD remain a significant cause of concern. Single-session POEM with fundoplication (POEM-F) to treat achalasia was recently described to reduce post-POEM GERD. This study aims to report the technical feasibility, safety, and early outcomes of the first U.S. cohort of POEM-F. METHODS: We retrospectively reviewed all patients with achalasia treated with POEM-F at our center. The primary endpoint was technical success, defined as the successful completion of all steps of the POEM-F procedure. RESULTS: Six patients (mean age, 50 ± 4.8 years; 1 woman) underwent POEM-F for achalasia. Technical success was achieved in all patients (6/6), and no major immediate or delayed (up to 30 days postprocedure) adverse events were seen. At the 1-month follow-up visit, the mean Eckardt score decreased from 8.8 ± 1.1 to .3 ± .5. The GERD health-related quality of life and reflux symptom index scores obtained at the 1-month follow-up, with patients on proton pump inhibitors, were 2.3 ± 3.7 and 2.2 ± 2.5, respectively. CONCLUSIONS: This first case series on POEM-F in the United States suggests that POEM-F is feasible and safe with excellent short-term outcomes.

Suturing a 20-mm lumen-apposing metal stent allows for safe same-session EUS-directed transgastric intervention in patients with Roux-en-Y gastric bypass anatomy: a multicenter study (with video).

BACKGROUND AND AIMS: EUS-directed transgastric intervention (EDGI) is an established technique for the management of pancreaticobiliary pathology in Roux-en-Y gastric bypass (RYGB) patients. There is an inherent risk of intraprocedural stent dislodgement, leading to perforation. The procedure is therefore often performed in 2 stages, 2 to 4 weeks apart, to allow for fistula maturation to mitigate the risk of lumen-apposing metal stent (LAMS) dislodgment. However, some clinical indications such as cholangitis require more urgent intervention, rendering this approach impractical. The aim of this study was to evaluate the safety and efficacy of same-session (SS)-EDGI with fixation of a 20-mm LAMS using endoscopic suturing. METHODS: This was a 2-center, retrospective study of consecutive RYGB patients who underwent SS-EDGI using a sutured 20-mm LAMS between February 2018 and May 2020. Patient demographics, procedural details, and clinical outcomes were recorded. RESULTS: Thirty-seven patients (mean age, 58.1 years; 86.5% women) underwent SS-EDGI with a median follow-up of 31.8 months. The procedural intervention was ERCP in 33 patients (89.2%) and ERCP with EUS in 4 patients (10.8%). Technical success was 100%. Access was achieved through the gastrogastric fistula in 26 patients (70.3%) and the jejunogastric fistula in 11 (29.7%). The LAMS was anchored with 2 endoscopic sutures in 33 patients (89.2%) and 1 suture in 4 (10.8%). Adverse events occurred in 4 patients (10.8%; 3 postprocedural bleeding, 1 cholangitis). There were no episodes of stent dislodgement or delayed stent migration. A persistent fistula was diagnosed in 7 patients (18.9%) who underwent objective testing (n = 28, 75.7%), of which 6 were successfully closed endoscopically. CONCLUSIONS: Single-stage EDGI using a sutured 20-mm LAMS was associated with a high rate of technical success, low rates of adverse events, and no episodes of stent migration. Persistent fistulas, although common, were amenable to endoscopic management.

Factors predictive of persistent fistulas in EUS-directed transgastric ERCP: a multicenter matched case-control study.

BACKGROUND AND AIMS: EUS-directed transgastric ERCP (EDGE) is an established method for managing pancreaticobiliary pathology in Roux-en-Y gastric bypass patients, with high rates of technical success and low rates of serious adverse events (AEs). However, widespread adoption of the technique has been limited because of concerns about the development of persistent gastrogastric or jejunogastric fistulas. Gastrogastric and jejunogastric fistulas have been reported in up to 20% of cases in some series, but predictive risk factors and long-term management and outcomes are lacking. Therefore, our aims were to assess factors associated with the development of persistent fistulas and the technical success of endoscopic fistula closure. METHODS: This is a case-control study involving 9 centers (8 USA, 1 Europe) from February 2015 to September 2021. Cases of persistent fistulas were defined as endoscopic or imaging evidence of fistula more than 8 weeks after lumen-apposing metal stent (LAMS) removal. Control subjects were defined as endoscopic or imaging confirmation of no fistula more than 8 weeks after LAMS removal. AEs were defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: Twenty-five patients identified to have evidence of a persistent fistula on follow-up surveillance (cases) were matched with 50 patients with no evidence of a persistent fistula on follow-up surveillance (control subjects) based on age and sex. Mean LAMS dwell time was 74.7 ± 106.2 days. After LAMS removal, argon plasma coagulation (APC) ablation of the fistula was performed in 46 patients (61.3%). Primary closure of the fistula was performed in 26.7% of patients (20: endoscopic suturing in 17, endoscopic tacking in 2, and over-the-scope clips + endoscopic suturing in 1). When comparing cases with control subjects, there was no difference in baseline demographics, fistula site, LAMS size, or primary closure frequency between the 2 groups (P > .05). However, in the persistent fistula group, the mean LAMS dwell time was significantly longer (127 vs 48 days, P = .02) and more patients had ≥5% total body weight gain (33.3% vs 10.3%, P = .03). LAMS dwell time was a significant predictor of persistent fistula (odds ratio, 4.5 after >40 days in situ, P = .01). The odds of developing a persistent fistula increased by 9.5% for every 7 days the LAMS was left in situ. In patients with a persistent fistula, endoscopic closure was attempted in 19 (76%) with successful resolution in 14 (73.7%). CONCLUSIONS: Longer LAMS dwell time was found to be associated with a higher risk of persistent fistulas in EDGE patients. APC or primary closure of the fistula on LAMS removal was not found to be protective against developing a persistent fistula, which, if present, can be effectively managed through endoscopic closure in most cases.

Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials.

BACKGROUND AND AIMS: The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs). METHODS: The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality. RESULTS: One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P = .48). CONCLUSIONS: The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.

Gastric peroral endoscopic myotomy for management of refractory gastroparesis in patients with gastric neurostimulator devices: a multicenter retrospective case control study.

BACKGROUND AND AIMS: Gastric neurostimulation (GNS) and gastric peroral myotomy (G-POEM), therapies for refractory gastroparesis, are associated with suboptimal outcomes. We studied the role of G-POEM as a salvage therapy in patients with refractory symptoms after GNS implantation. METHODS: This was a multicenter, retrospective, matched case-control study. Consecutive patients with a GNS device and who underwent G-POEM as a salvage therapy for clinical failure (cases) and patients without GNS implantation and who underwent G-POEM for refractory gastroparesis (control) between October 2018 and August 2021 were included. The primary outcome was clinical success after G-POEM. RESULTS: A total of 123 patients (mean age 45.7 ± 14.7 years; 88 female subjects [72%]) underwent G-POEM therapy during the study: 41 cases and 82 controls. Clinical success was achieved in 66% in the case group and 65% in the control group (P = .311), during a median total clinical follow-up time of 11.8 (interquartile range, 2.4-6.3) months. In the case group, the mean Gastroparesis Cardinal Symptom Index score decreased from 2.8 ± 1.8 to 1.5 ± 1.9 (P = .024), and gastric retention at 4 hours improved from 45% ± 25.8% to 16.6% ± 13.1% (P = .06). The mean delta improvement in the subscales of nausea/vomiting (1.3 ± .6 vs .9 ± 1.1, P = .044) and bloating (1.6 ± 1.3 vs 1.2 ± 1.4, P = .041) were significantly higher in cases than in controls. CONCLUSIONS: Among patients with refractory symptoms after GNS, G-POEM can be a reasonable salvage therapy to provide further symptomatic relief with evidence of a potential additive effect of both G-POEM and GNS.

Novel through-the-scope suture closure of colonic EMR defects (with video).

BACKGROUND AND AIMS: Large colon polyps removed by EMR can be complicated by delayed bleeding. Prophylactic defect clip closure can reduce post-EMR bleeding. Larger defects can be challenging to close using through-the-scope clips (TTSCs), and proximal defects are difficult to reach using over-the-scope techniques. A novel, through-the-scope suturing (TTSS) device allows direct closure of mucosal defects without scope withdrawal. The goal of this study was to evaluate the rate of delayed bleeding after the closure of large colon polyp EMR sites with TTSS. METHODS: A multicenter retrospective cohort study was performed involving 13 centers. All defect closure by TTSS after EMR of colon polyps ≥2 cm from January 2021 to February 2022 were included. The primary outcome was rate of delayed bleeding. RESULTS: A total of 94 patients (52% female; mean age, 65 years) underwent EMR of predominantly right-sided (n = 62 [66%]) colon polyps (median size, 35 mm; interquartile range, 30-40 mm) followed by defect closure with TTSS during the study period. All defects were successfully closed with TTSS alone (n = 62 [66%]) or with TTSS and TTSCs (n = 32 [34%]), using a median of 1 (interquartile range, 1-1) TTSS system. Delayed bleeding occurred in 3 patients (3.2%), with 2 requiring repeated endoscopic evaluation/treatment (moderate). CONCLUSION: TTSS alone or with TTSCs was effective in achieving complete closure of all post-EMR defects, despite a large lesion size. After TTSS closure with or without adjunctive devices, delayed bleeding was seen in 3.2% of cases. Further prospective studies are needed to validate these findings before wider adoption of TTSS for large polypectomy closure.

Through-the-scope suture closure of peroral endoscopic myotomy mucosal incision sites.

BACKGROUND : Peroral endoscopic myotomy (POEM) is now widely used for esophageal motility disorders including achalasia. Closure of the mucosal incision site is a critical step of the procedure. We evaluated the use of a novel through-the-scope (TTS) suture system for closure of POEM mucosal incision sites. METHODS : We retrospectively reviewed consecutive patients who underwent POEM with TTS suture closure at our institution between February and July 2021. Technical success was defined as complete mucosal incision site closure using TTS suturing, without the need for adjunctive devices. Continuous variables are presented as median (interquartile range [IQR]) or mean (SD). RESULTS : 35 consecutive patients (median age 58 years [IQR 46.5-72]; 54.3 % female) underwent POEM with attempted mucosal closure by TTS suturing. Technical success was achieved in 32 patients (91.4 %) with a mean closure time of 12.4 (SD 6.9) minutes. The median mucosal incision length at time of closure was 2.5 cm (IQR 2-2.5). Overall, 17 patients (53.1 %) required ≥ 2 TTS suture systems and 3 patients (8.6 %) required additional TTS clips to achieve secure mucosal closure. No adverse events were encountered. CONCLUSIONS : TTS suturing was effective and safe for POEM mucosotomy closure. However, prospective comparative trials and cost-effectiveness analyses are warranted before routine adoption.

Zenker's peroral endoscopic myotomy for management of large Zenker's diverticulum.

BACKGROUND: Zenker's diverticulum peroral endoscopic myotomy (zPOEM) is a minimally invasive treatment strategy for Zenker's diverticulum, with excellent results for management of small-to-moderate Zenker's diverticulum. We evaluated its use in the management of large Zenker's diverticulum. METHODS: This was a retrospective multicenter cohort study across 11 international centers including adult patients with large Zenker's diverticulum ≥ 40 mm treated by zPOEM between March 2017 and March 2022. The primary outcome was clinical success (dysphagia score ≤ 1 without need for further intervention). Secondary outcomes included technical success (complete myotomy as intended), adverse events (AEs), and rate of recurrence. RESULTS: 83 patients (male 62.7 %, mean age 72.6 [SD 11.5] years) underwent zPOEM for treatment of large Zenker's diverticulum (median size 50 mm, interquartile range [IQR] 41-55 mm, range 40-80 mm). The zPOEM procedure was technically successful in 82 patients (98.8 %), with a mean procedure time of 48.7 (SD 23.2) minutes. Clinical success was achieved in 71 patients (85.5 %). Median (IQR) symptom scores improved significantly from baseline for dysphagia (2 2 3 vs. 0 [0-2]; P < 0.001), regurgitation (3 2 3 4 vs. 0 [0-0]; P < 0.001), and respiratory symptoms (2 [0-3] vs. 0 [0-0]; P < 0.001). Among patients achieving clinical success, only one recurrence (1.4 %) was recorded during a median follow-up of 12.2 months (IQR 3-28). Post-procedure AEs, all mild to moderate, occurred in four patients (4.8 %). CONCLUSION: This study demonstrated safe and effective use of zPOEM in the management of large Zenker's diverticulum.

Through-the-scope suture closure of nonampullary duodenal endoscopic mucosal resection defects: a retrospective multicenter cohort study.

BACKGROUND: Delayed bleeding is among the most common adverse events associated with endoscopic mucosal resection (EMR) of nonampullary duodenal polyps. We evaluated the rate of delayed bleeding and complete defect closure using a novel through-the-scope (TTS) suturing system for the closure of duodenal EMR defects. METHODS: We reviewed the electronic medical records of patients who underwent EMR for nonampullary duodenal polyps of ≥ 10 mm and prophylactic defect closure with TTS suturing between March 2021 and May 2022 at centers in the USA. We evaluated the rates of delayed bleeding and complete defect closure. RESULTS: 36 nonconsecutive patients (61 % women; mean [SD] age, 65 [12] years) underwent EMR of ≥ 10-mm duodenal polyps followed by attempted defect closure with TTS suturing. The mean (SD) lesion size was 29 (19) mm, defect size was 37 (25) mm; eight polyps (22 %) involved > 50 % of the lumen circumference. Complete closure was achieved in all cases (78 % with TTS suturing alone), using a median of one TTS suturing kit. There were no cases of delayed bleeding and no adverse events attributed to application of the TTS suturing device. CONCLUSION: Prophylactic closure of nonampullary duodenal EMR defects using TTS suturing resulted in a high rate of complete closure and no delayed bleeding events.

A novel through-the-scope helix tack-and-suture device for mucosal defect closure following colorectal endoscopic submucosal dissection: a multicenter study.

BACKGROUND: Complete closure of large mucosal defects following colorectal endoscopic submucosal dissection (ESD) with through-the-scope (TTS) clips is oftentimes not possible. We aimed to report our early experience of using a novel TTS suturing system for the closure of large mucosal defects after colorectal ESD. METHODS: We performed a retrospective multicenter cohort study of consecutive patients who underwent attempted prophylactic defect closure using the TTS suturing system after colorectal ESD. The primary outcome was technical success in achieving complete defect closure, defined as a < 5 mm residual mucosal defect in the closure line using TTS suturing, with or without adjuvant TTS clips. RESULTS: 82 patients with a median defect size of 30 (interquartile range 25-40) mm were included. Technical success was achieved in 92.7 % (n = 76): TTS suturing only in 44 patients (53.7 %) and a combination of TTS suturing to approximate the widest segment followed by complete closure with TTS clips in 32 (39.0 %). Incomplete/partial closure, failure of appropriate TTS suture deployment, and the need for over-the-scope salvage closure methods were observed in 7.3 % (n = 6). One intraprocedural bleed, one delayed bleed, and three intraprocedural perforations were observed. There were no adverse events related to placement of the TTS suture. CONCLUSION: The TTS suture system is an effective and safe tool for the closure of large mucosal defects after colorectal ESD and is an alternative when complete closure with TTS clips alone is not possible.

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.

Rectal INdomethacin, oral TacROlimus, or their combination for the prevention of post-ERCP pancreatitis (INTRO Trial): Protocol for a randomized, controlled, double-blinded trial.

BACKGROUND: Acute pancreatitis remains the most common and morbid complication of endoscopic retrograde cholangiopancreatography (ERCP). The use of rectal indomethacin and pancreatic duct stenting has been shown to reduce the incidence and severity of post-ERCP pancreatitis (PEP), but these interventions have limitations. Recent clinical and translational evidence suggests a role for calcineurin inhibitors in the prevention of pancreatitis, with multiple retrospective case series showing a reduction in PEP rates in tacrolimus users. METHODS: The INTRO trial is a multicenter, international, randomized, double-blinded, controlled trial. A total of 4,874 patients undergoing ERCP will be randomized to receive either oral tacrolimus (5 mg) or oral placebo 1-2 h before ERCP, and followed for 30 days post-procedure. Blood and pancreatic aspirate samples will also be collected in a subset of patients to quantify tacrolimus levels. The primary outcome of the study is the incidence of PEP. Secondary endpoints include the severity of PEP, ERCP-related complications, adverse drug events, length of hospital stay, cost-effectiveness, and the pharmacokinetics, pharmacodynamics, and pharmacogenomics of tacrolimus immune modulation in the pancreas. CONCLUSIONS: The INTRO trial will assess the role of calcineurin inhibitors in PEP prophylaxis and develop a foundation for the clinical optimization of this therapeutic strategy from a pharmacologic and economic standpoint. With this clinical trial, we hope to demonstrate a novel approach to PEP prophylaxis using a widely available and well-characterized class of drugs. TRIAL REGISTRATION: NCT05252754, registered on February 14, 2022.

Early infection is an independent risk factor for increased mortality in patients with culture-confirmed infected pancreatic necrosis.

BACKGROUND: Mortality in infected pancreatic necrosis (IPN) is dynamic over the course of the disease, with type and timing of interventions as well as persistent organ failure being key determinants. The timing of infection onset and how it pertains to mortality is not well defined. OBJECTIVES: To determine the association between mortality and the development of early IPN. METHODS: International multicenter retrospective cohort study of patients with IPN, confirmed by a positive microbial culture from (peri) pancreatic collections. The association between timing of infection onset, timing of interventions and mortality were assessed using Cox regression analyses. RESULTS: A total of 743 patients from 19 centers across 3 continents with culture-confirmed IPN from 2000 to 2016 were evaluated, mortality rate was 20.9% (155/734). Early infection was associated with a higher mortality, when early infection occurred within the first 4 weeks from presentation with acute pancreatitis. After adjusting for comorbidity, advanced age, organ failure, enteral nutrition and parenteral nutrition, early infection (≤4 weeks) and early open surgery (≤4 weeks) were associated with increased mortality [HR: 2.45 (95% CI: 1.63-3.67), p < 0.001 and HR: 4.88 (95% CI: 1.70-13.98), p = 0.003, respectively]. There was no association between late open surgery, early or late minimally invasive surgery, early or late percutaneous drainage with mortality (p > 0.05). CONCLUSION: Early infection was associated with increased mortality, independent of interventions. Early surgery remains a strong predictor of excess mortality.

EUS-directed transgastric interventions in Roux-en-Y gastric bypass anatomy: a multicenter experience.

BACKGROUND AND AIMS: Placement of a lumen-apposing metal stent (LAMS) between the gastric pouch and the excluded stomach allows for EUS-guided transgastric interventions (EDGIs) in patients with Roux-en-Y gastric bypass (RYGB). Although EUS-guided transgastric ERCP (EDGE) outcomes have been reported, data are scant on other endoscopic interventions. We aimed to evaluate the outcomes and safety of EDGIs. METHODS: This retrospective study involved 9 centers (United States, 8; Europe, 1) and included patients with RYGB who underwent EDGIs between June 2015 and September 2021. The primary outcome was the technical success of EDGIs. Secondary outcomes were adverse events (AEs), length of hospital stay, and fistula follow-up and management. RESULTS: Fifty-four EDGI procedures were performed in 47 patients (mean age, 61 years; 72% women), most commonly for the evaluation of a pancreatic mass (n = 16) and management of pancreatic fluid collections (n = 10). A 20-mm LAMS was used in 26 patients and a 15-mm LAMS in 21, creating a gastrogastrostomy in 37 patients and jejunogastrostomy in 10. Most patients (n = 30, 64%) underwent a dual-session EDGI, with a median interval of 17 days between the 2 procedures. Single-session EDGI was performed in 17 patients, of whom 10 (59%) had anchoring of the LAMS. The most common interventions were diagnostic EUS (with or without FNA or fine-needle biopsy sampling; n = 28) and EUS-guided cystgastrostomy (n = 8). The mean procedural time was 97.6 ± 78.9 minutes. Technical success was achieved in 52 patients (96%). AEs occurred in 5 patients (10.6%), of which only 1 AE (2.1%) was graded as severe. Intraprocedural LAMS migration was the most common AE, occurring in 3 patients (6.4%), whereas delayed spontaneous LAMS migration occurred in 2 (4.3%). Four of the 5 LAMS migration events were managed endoscopically, and 1 required surgical repair. LAMS anchoring was found to be protective against LAMS migration (P = .001). The median duration of hospital stay was 2.1 ± 3.7 days. Of the 17 patients who underwent objective fistula assessment endoscopically or radiologically after LAMS removal, 2 (11.7%) were found to have persistent fistulas. In 1 case the fistula was intentionally left open to assist with weight gain. The other fistula was successfully closed endoscopically. CONCLUSIONS: EDGI is effective and safe for the diagnosis and management of pancreaticobiliary and foregut disorders in RYGB patients. It is associated with high rates of technical success and low rates of severe AEs. LAMS migration is the most common AE with evidence that anchoring can be protective against its occurrence. Persistent fistulas may occur, but endoscopic closure seems to be effective.