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

Stassen, Pauline M.; Jonge, P.J.F. de; Bruno, Marco J.; Koch, Arjun D.; Trindade, Arvind J.; Benias, Petros C.; Sejpal, Divyesh V.; Siddiqui, Uzma D.; Chapman, Christopher G.; Villa, Edward; Tharian, Benjamin; Inamdar, Sumant; Hwang, Joo Ha; Barakat, Monique T.; Andalib, Iman; Gaidhane, Monica; Sarkar, Avik; Shahid, Haroon; Tyberg, Amy; Binmoeller, Kenneth F.; Watson, Rabindra R.; Nett, Andrew; Schlag, Christoph; Abdelhafez, Mohamed; Friedrich‐Rust, Mireen; Schlachterman, Alexander; Chiang, Austin L.; Loren, David E.; Kowalski, Thomas E.; Kahaleh, Michel

doi:10.1016/j.gie.2021.09.025

Cited by 27 publications

(26 citation statements)

References 16 publications

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“…In addition, snares often cut through the soft necrotic tissue rather than capturing it. Therefore, other systems for necrosectomy have been tested recently, such as the EndoRotor TM (Interscope Inc., Northbridge, Massachusetts, United States), a technically complex device originally developed for polypectomy and available only in a few centers[ 6 , 13 , 14 ].…”

Section: Discussionmentioning

confidence: 99%

“…In the case of endoscopic pancreatic necrosectomy, some new tools for endoscopic ultrasound (EUS) guided access to the necrotic cavity have been developed, such as lumen apposing metal stents (LAMS)[ 5 ]. Dedicated instruments for necrosectomy are scarce, although a new motorized device (EndoRotor TM ) has been tested for this indication, providing encouraging data[ 6 ]. Therefore, in addition to suction and irrigation, various snares, baskets, or forceps are usually used to remove the tough and sticky necrotic tissue from the retroperitoneal cavity.…”

Section: Introductionmentioning

confidence: 99%

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Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience

Brand¹,

Bachmann²,

Schlag³

et al. 2022

WJGS

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BACKGROUND Endoscopic treatment of pancreatic necrosis can be challenging and time-consuming because sticky necrotic debris is sometimes difficult to remove. The over-the-scope-grasper, a new tool that has recently become available for this purpose, might also be useful for other indications. However, clinical data on the efficacy and safety of this new device are lacking. AIM To evaluate the technical success and safety of the device in a multicenter setting. METHODS The over-the-scope-grasper was used in nine selected endoscopic centers between November 2020 and October 2021 for appropriate indications. Overall, 56 procedures were included in the study. We retrospectively evaluated procedural parameters of all endoscopic interventions using a predefined questionnaire, with special respect to technical success, indications, duration of intervention, type of sedation, and complications. In the case of pancreatic necrosectomy, the access route, stent type, number of necrosis pieces removed, and clinical handling were also recorded. RESULTS A total of 56 procedures were performed, with an overall technical success rate of 98%. Most of the procedures were endoscopic pancreatic necrosectomies (33 transgastric, 4 transduodenal). In 70% of the procedures, access to the necrotic cavity was established with a lumen apposing metal stent. The technical success of pancreatic necrosectomy was 97%, with a mean of 8 pieces (range, 2-25 pieces) of necrosis removed in a mean procedure time of 59 min (range, 15-120 min). In addition, the device has been used to remove blood clots ( n = 6), to clear insufficiency cavities before endoluminal vacuum therapy ( n = 5), and to remove foreign bodies from the upper gastrointestinal tract ( n = 8). In these cases, the technical success rate was 100%. No moderate or severe/fatal complications were reported in any of the 56 procedures. CONCLUSION These first multicenter data demonstrate that the over-the-scope-grasper is a promising device for endoscopic pancreatic necrosectomy, which is also appropriate for removing foreign bodies and blood clots, or cleaning insufficiency cavities prior to endoluminal vacuum therapy.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience

Brand¹,

Bachmann²,

Schlag³

et al. 2022

WJGS

Self Cite

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“…Endorotor is an automated device for endoscopic necrosectomy which is recently authorized for marketing by FDA 33 34 . Further controlled studies should be conducted to assess the effect of such dedicated devices on reducing the number of procedures or duration of hospital stay.…”

Section: Discussionmentioning

confidence: 99%

Endoscopic or surgical treatment for necrotizing pancreatitis: Comprehensive systematic review and meta-analysis

et al. 2022

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Background and study aims Treatment of necrotizing pancreatitis is changed over the past two decades with the availability of endoscopic, and minimally invasive surgical approaches. The aim of this systematic review was to assess outcomes of endoscopic drainage, and different types of surgical drainage approaches in necrotizing pancreatitis. Methods Medline, Embase, Scopus, and Web of Science were searched from 1998 to 2020 to assess outcomes in endoscopic drainage and various surgical drainage procedures. The assessed variables consisted of mortality, development of pancreatic or enteric fistula, new onset diabetes mellitus, and exocrine pancreatic insufficiency. Results One hundred seventy studies comprising 11,807 patients were included in the final analysis. The pooled mortality rate was 22 % (95 % confidence interval [CI]: 19%–26 %) in the open surgery (OS), 8 % (95 %CI:5 %–11 %) in minimally invasive surgery (MIS), 13 % (95 %CI: 9 %–18 %) in step-up approach, and 3 % (95 %CI:2 %–4 %) in the endoscopic drainage (ED). The pooled rate of fistula formation was 35 % (95 %CI:28 %–41 %) in the OS, 17 % (95 %CI: 12%–23 %) in MIS, 17 % (95 %CI: 9 %–27 %) in step-up approach, and 2 % (95 %CI: 0 %–4 %) in ED. There were 17 comparative studies comparing various surgical drainage methods with ED. The mortality rate was significantly lower in ED compared to OS (risk ratio [RR]: 30; 95 %CI: 0.20–0.45), and compared to MIS (RR: 0.40; 95 %CI: 0.26–0.6). Also, the rate of fistula formation was lower in ED compared to all other surgical drainage approaches. Conclusions This systematic review demonstrated lower rate of fistula formation with ED compared to various surgical drainage methods. A lower rate of mortality with ED was also observed in observational studies. PROSPERO Identifier: CRD42020139354

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“…After two small series by Van Der Wiel et al [67] and Larghi et al [68], reporting a successful use of the EndoRotor ® to perform DEN, Stassen et al conducted the first multicenter prospective trial involving 30 patients with symptomatic WOPN requiring DEN, whose results were recently published on the Gastrointestinal Endoscopy Journal [69]. They reported a median number of 1.5 EndoRotor ® -assisted DENs required to achieve an average reduction of 85% in collection volume and 91% of necrotic debris.…”

Section: Devicesmentioning

confidence: 99%

Direct Endoscopic Necrosectomy: Timing and Technique

Pinto

Bellizzi²,

Badas

et al. 2021

Medicina

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Walled-off pancreatic necrosis (WOPN) is one of the local complications of acute pancreatitis (AP). Several interventional techniques have been developed over the last few years. The purpose of this narrative review is to explore such methodologies, with specific focus on endoscopic drainage and direct endoscopic necrosectomy (DEN), through evaluation of their indications and timing for intervention. Findings indicated how, after the introduction of lumen-apposing metal stents (LAMS), DEN is becoming the favorite technique to treat WOPN, especially when large solid debris or infection are present. Additionally, DEN is associated with a lower adverse events rate and hospital stay, and with improved clinical outcome.

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

Cited by 27 publications

References 16 publications

Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience

Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience

Endoscopic or surgical treatment for necrotizing pancreatitis: Comprehensive systematic review and meta-analysis

Direct Endoscopic Necrosectomy: Timing and Technique

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