Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System

NCT06691919 | Withdrawn FDA Device

• 1 other identifier: 78066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Goal: The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis. Participant Population: The study will involve adult patients experiencing symptomatic WON due to acute necrotizing pancreatitis. Main Questions: The main questions it aims to answer are:

1. 1.Is "endoscopy" or direct endoscopic necrosectomy (DEN) with powered endoscopic debridement (PED) as effective as "surgery" or transgastric surgical necrosectomy (SN) in achieving clinical resolution of WON within six weeks after treatment?
2. 2.What are the rates of complications, costs, hospital length of stay, procedure time, readmission, repeat procedures and overall patient satisfaction associated with DEN with PED compared to transgastric SN?
3. 3.Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN).
4. 4.Undergo the assigned treatment procedure based on their group.
5. 5.Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction.
6. 6.Be monitored for adverse events or complications following the treatment

Conditions

Pancreatic Necrosis; Pancreatitis

Keywords

Direct Endoscopy Necrosectomy; Transgastric Surgical Necrosectomy; Powered Endoscopic Debridement; Pancreatic Necrosis; Walled of Pancreatic Necrosis; Necrotizing Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Treatment Success at 6 weeks after Debridement

  Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. AND Radiographic resolution defined as \>70% reduction in WON on CT or MR imaging.

  From initial intervention to 6 weeks

Secondary Outcomes (17)

• Overall treatment success rate at end of 6-month follow-up from date of intervention

  From initial intervention to the end of followup at 6 months

• Clinical improvement within 72 hours of debridement

  From initial intervention to 72 hours after treatment

• Clinical Failure at 6 months

  From initial intervention to the end of followup at 6 months

• 30-day mortality

  From initial intervention to followup at 30 days

• Overall total cost of care

  From initial intervention to the end of followup at 6 months

Study Arms (2)

Direct Endoscopic Necrosectomy

EXPERIMENTAL

Subjects randomized to the endoscopy arm will undergo direct endoscopic necrosectomy using the Powered Endoscopic Debridement System which has CE-Mark 613797 and FDA De Novo clearance in the United States (DEN200016).

Device: Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement

Transgastric Surgical Necrosectomy

EXPERIMENTAL

Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric surgical necrosectomy (SN). In either approach, the peritoneal cavity is entered to identify the stomach through which an anterior gastrotomy is made. The retrogastric necrosum is identified either using a finder needle or ultrasound and accessed through a posterior cystgastrostomy. Transgastric SN is then manually performed, and any cyst fluid fully evacuated. The anterior gastrotomy is then closed allowing any residual necrosis or pancreatic enzyme to efflux into the stomach and enter the upper GI tract. As with endoscopy, patients with retrogastric collections are observed for a sufficient period to ensure full maturation of the necrosum.

Procedure: Transgastric Surgical Necrosectomy

Interventions

Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement DEVICE

Patients will first undergo endoscopic ultrasound-guided cystgastrostomy using an electrocautery-enhanced lumen apposing metallic stent to gain access to the necrosum. Direct Endoscopic Necrosectomy will be performed using the EndoRotor® NecroMax 6.0 PED Catheter which has an outer diameter of 5.1 mm and is compatible with endoscopes that have a working channel of ≥6.0 mm.

Direct Endoscopic Necrosectomy

Transgastric Surgical Necrosectomy PROCEDURE

Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric SN with the aim of creating an ample size cystgastrostomy to perform a complete debridement. In either approach, the peritoneal cavity is entered to identify the stomach through which an anterior gastrotomy is made. The retrogastric necrosum is identified either using a finder needle or ultrasound and accessed through a posterior cystgastrostomy. Transgastric SN is then manually performed, and any cyst fluid fully evacuated. The anterior gastrotomy is then closed allowing any residual necrosis or pancreatic enzyme to efflux into the stomach and enter the upper GI tract. As with endoscopy, patients with retrogastric collections are observed for a sufficient period to ensure full maturation of the necrosum.

Transgastric Surgical Necrosectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or greater.
• Patients with first episode of symptomatic WON+ due to acute pancreatitis (+Persistent fatigue, malaise, abdominal pain, gastric outlet obstruction, early satiety, fever, chills, jaundice, reduced appetite, persistent nausea/vomiting, steatorrhea)
• Patients who are candidates for surgical or endoscopic necrosectomy of WON as deemed by a multidisciplinary committee of HPB surgeons and therapeutic endoscopists.
• Patients who can tolerate repeat procedures.
• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.

You may not qualify if:

• Documented untreated pseudoaneurysm within WON.
• Subject unable or unwilling to provide informed consent.
• Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using pre-procedural imaging).
• Coagulation disorders or anti-coagulant therapy which cannot be discontinued for the intervention to an absolute cardiac or vascular indication such as ACS, Stroke, Mechanical cardiovascular valves.
• Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
• Non-communicating pancreatic or extra-pancreatic fluid collections.
• Extensive abdominal surgical history due to peritoneal adhesions, prior open or recent operation during pancreatitis course, or remote gastric surgery that precludes a transgastric surgical cystgastrostomy.

Sponsors & Collaborators

• Stanford University: lead
• Indiana University Health: collaborator

Related Publications (20)

• Li AY, Bergquist JR, Visser BC. Necrosectomy in the Management of Necrotizing Pancreatitis. Adv Surg. 2021 Sep;55:231-250. doi: 10.1016/j.yasu.2021.05.016. No abstract available.

  PMID: 34389094 BACKGROUND

• Onnekink AM, Boxhoorn L, Timmerhuis HC, Bac ST, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SAW, Bruno MJ, van Brunschot S, Cappendijk VC, Consten ECJ, Dejong CH, Dijkgraaf MGW, van Eijck CHJ, Erkelens WG, van Goor H, van Grinsven J, Haveman JW, van Hooft JE, Jansen JM, van Lienden KP, Meijssen MAC, Nieuwenhuijs VB, Poley JW, Quispel R, de Ridder RJ, Romkens TEH, van Santvoort HC, Scheepers JJ, Schwartz MP, Seerden T, Spanier MBW, Straathof JWA, Timmer R, Venneman NG, Verdonk RC, Vleggaar FP, van Wanrooij RL, Witteman BJM, Fockens P, Voermans RP; Dutch Pancreatitis Study Group. Endoscopic Versus Surgical Step-Up Approach for Infected Necrotizing Pancreatitis (ExTENSION): Long-term Follow-up of a Randomized Trial. Gastroenterology. 2022 Sep;163(3):712-722.e14. doi: 10.1053/j.gastro.2022.05.015. Epub 2022 May 14.

  PMID: 35580661 BACKGROUND

• Olsen GA, Schmidt PN, Novovic S, Hansen EF, Karstensen JG. Novel powered 5.0-mm endoscopic debridement catheter for endoscopic transmural necrosectomy of pancreatic walled-off necrosis: a case series of consecutive patients from a tertiary referral center (with video). Gastrointest Endosc. 2024 Feb;99(2):267-270. doi: 10.1016/j.gie.2023.10.044. Epub 2023 Oct 20.

  PMID: 37865281 BACKGROUND

• Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031. Epub 2018 Nov 16.

  PMID: 30452918 BACKGROUND

• van Brunschot S, van Grinsven J, van Santvoort HC, Bakker OJ, Besselink MG, Boermeester MA, Bollen TL, Bosscha K, Bouwense SA, Bruno MJ, Cappendijk VC, Consten EC, Dejong CH, van Eijck CH, Erkelens WG, van Goor H, van Grevenstein WMU, Haveman JW, Hofker SH, Jansen JM, Lameris JS, van Lienden KP, Meijssen MA, Mulder CJ, Nieuwenhuijs VB, Poley JW, Quispel R, de Ridder RJ, Romkens TE, Scheepers JJ, Schepers NJ, Schwartz MP, Seerden T, Spanier BWM, Straathof JWA, Strijker M, Timmer R, Venneman NG, Vleggaar FP, Voermans RP, Witteman BJ, Gooszen HG, Dijkgraaf MG, Fockens P; Dutch Pancreatitis Study Group. Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial. Lancet. 2018 Jan 6;391(10115):51-58. doi: 10.1016/S0140-6736(17)32404-2. Epub 2017 Nov 3.

  PMID: 29108721 BACKGROUND

• Seifert H, Biermer M, Schmitt W, Jurgensen C, Will U, Gerlach R, Kreitmair C, Meining A, Wehrmann T, Rosch T. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut. 2009 Sep;58(9):1260-6. doi: 10.1136/gut.2008.163733. Epub 2009 Mar 11.

  PMID: 19282306 BACKGROUND

• Puli SR, Graumlich JF, Pamulaparthy SR, Kalva N. Endoscopic transmural necrosectomy for walled-off pancreatic necrosis: a systematic review and meta-analysis. Can J Gastroenterol Hepatol. 2014 Jan;28(1):50-3. doi: 10.1155/2014/539783. Epub 2013 Nov 8.

  PMID: 24212912 BACKGROUND

• Worhunsky DJ, Qadan M, Dua MM, Park WG, Poultsides GA, Norton JA, Visser BC. Laparoscopic transgastric necrosectomy for the management of pancreatic necrosis. J Am Coll Surg. 2014 Oct;219(4):735-43. doi: 10.1016/j.jamcollsurg.2014.04.012. Epub 2014 May 29.

  PMID: 25158913 BACKGROUND

• Fugazza A, Sethi A, Trindade AJ, Troncone E, Devlin J, Khashab MA, Vleggaar FP, Bogte A, Tarantino I, Deprez PH, Fabbri C, Aparicio JR, Fockens P, Voermans RP, Uwe W, Vanbiervliet G, Charachon A, Packey CD, Benias PC, El-Sherif Y, Paiji C, Ligresti D, Binda C, Martinez B, Correale L, Adler DG, Repici A, Anderloni A. International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage. Gastrointest Endosc. 2020 Mar;91(3):574-583. doi: 10.1016/j.gie.2019.11.021. Epub 2019 Nov 20.

  PMID: 31759037 BACKGROUND

• van der Wiel SE, Poley JW, Grubben MJAL, Bruno MJ, Koch AD. The EndoRotor, a novel tool for the endoscopic management of pancreatic necrosis. Endoscopy. 2018 Sep;50(9):E240-E241. doi: 10.1055/a-0628-6136. Epub 2018 Jun 19. No abstract available.

  PMID: 29920619 BACKGROUND

• Maatman TK, McGuire SP, Flick KF, Madison MK, Al-Haddad MA, Bick BL, Ceppa EP, DeWitt JM, Easler JJ, Fogel EL, Gromski MA, House MG, Lehman GA, Nakeeb A, Schmidt CM, Sherman S, Watkins JL, Zyromski NJ. Outcomes in Endoscopic and Operative Transgastric Pancreatic Debridement. Ann Surg. 2021 Sep 1;274(3):516-523. doi: 10.1097/SLA.0000000000004997.

  PMID: 34238810 BACKGROUND

• Stassen PMC, de Jonge PJF, Bruno MJ, Koch AD, Trindade AJ, Benias PC, Sejpal DV, Siddiqui UD, Chapman CG, Villa E, Tharian B, Inamdar S, Hwang JH, Barakat MT, Andalib I, Gaidhane M, Sarkar A, Shahid H, Tyberg A, Binmoeller K, Watson RR, Nett A, Schlag C, Abdelhafez M, Friedrich-Rust M, Schlachterman A, Chiang AL, Loren D, Kowalski T, Kahaleh M. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc. 2022 Mar;95(3):471-479. doi: 10.1016/j.gie.2021.09.025. Epub 2021 Sep 22.

  PMID: 34562471 BACKGROUND

• Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X. Epub 2023 Nov 18.

  PMID: 37980922 BACKGROUND

• Driedger M, Zyromski NJ, Visser BC, Jester A, Sutherland FR, Nakeeb A, Dixon E, Dua MM, House MG, Worhunsky DJ, Munene G, Ball CG. Surgical Transgastric Necrosectomy for Necrotizing Pancreatitis: A Single-stage Procedure for Walled-off Pancreatic Necrosis. Ann Surg. 2020 Jan;271(1):163-168. doi: 10.1097/SLA.0000000000003048.

  PMID: 30216220 BACKGROUND

• Bakker OJ, van Santvoort HC, van Brunschot S, Geskus RB, Besselink MG, Bollen TL, van Eijck CH, Fockens P, Hazebroek EJ, Nijmeijer RM, Poley JW, van Ramshorst B, Vleggaar FP, Boermeester MA, Gooszen HG, Weusten BL, Timmer R; Dutch Pancreatitis Study Group. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA. 2012 Mar 14;307(10):1053-61. doi: 10.1001/jama.2012.276.

  PMID: 22416101 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

  PMID: 23896955 BACKGROUND

• Arvanitakis M, Dumonceau JM, Albert J, Badaoui A, Bali MA, Barthet M, Besselink M, Deviere J, Oliveira Ferreira A, Gyokeres T, Hritz I, Hucl T, Milashka M, Papanikolaou IS, Poley JW, Seewald S, Vanbiervliet G, van Lienden K, van Santvoort H, Voermans R, Delhaye M, van Hooft J. Endoscopic management of acute necrotizing pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) evidence-based multidisciplinary guidelines. Endoscopy. 2018 May;50(5):524-546. doi: 10.1055/a-0588-5365. Epub 2018 Apr 9.

  PMID: 29631305 BACKGROUND

• Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.

  PMID: 26327134 BACKGROUND

• Trikudanathan G, Wolbrink DRJ, van Santvoort HC, Mallery S, Freeman M, Besselink MG. Current Concepts in Severe Acute and Necrotizing Pancreatitis: An Evidence-Based Approach. Gastroenterology. 2019 May;156(7):1994-2007.e3. doi: 10.1053/j.gastro.2019.01.269. Epub 2019 Feb 15.

  PMID: 30776347 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Joo Ha Hwang, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Biostatistician will be blinded to the study groups while performing final study analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: "Endoscopy" arm will receive direct endoscopic necrosectomy and "Surgery" arm will undergo transgastric surgical necrosectomy.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share