Pancreatic NecrosisSERPENTNCT06691919

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

A study testing Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement and Transgastric Surgical Necrosectomy in people with Pancreatic Necrosis and Pancreatitis, run by Stanford University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Necrosis, Pancreatitis
What is being tested?: Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement and Transgastric Surgical Necrosectomy
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Dec 2026to Oct 2027
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

About this study

Official title: Surgical vs Endoscopic Resection Of Walled Off Pancreatic Necrosis Using The Powered Endoscopic Debridement (PED) System - The SERPENT Trial

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:

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?
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?

Comparison Group:

Researchers will compare the outcomes of patients receiving DEN with PED to those undergoing transgastric SN to see if there are significant differences in clinical success, rates of complications, and overall healthcare costs.

Participants Will:

Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN).
Undergo the assigned treatment procedure based on their group.
Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction.
Be monitored for adverse events or complications following the treatment

Conditions: Pancreatic Necrosis, Pancreatitis
Being tested: Direct Endoscopic Necrosectomy with Powered Endoscopic Debridement, Transgastric Surgical Necrosectomy
Keywords: Direct Endoscopy Necrosectomy, Transgastric Surgical Necrosectomy, Powered Endoscopic Debridement, Pancreatic Necrosis, Walled of Pancreatic Necrosis, Necrotizing Pancreatitis
Medical subject headings: Pancreatitis, Acute Necrotizing, Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct Endoscopic Necrosectomy with Powered Endoscopic DebridementDevice
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.
Transgastric Surgical NecrosectomyProcedure or surgery
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.

Study groups in NCT06691919
Study group	Role	What they receive
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). Receives: 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. Receives: Procedure: Transgastric Surgical Necrosectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From initial intervention to 6 weeks

Secondary outcomes (17)

Overall treatment success rate at end of 6-month follow-up from date of intervention
Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions after completion of 6-month follow-up.
AND Radiographic resolution defined as >70% reduction in WON on CT or MR imaging after completion of 6-month follow-up.
Measured: From initial intervention to the end of followup at 6 months
Clinical improvement within 72 hours of debridement
Clinical improvement is defined according to the criteria used in the PANTER and TENSION trial. (8-10) "Clinical improvement" defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator's medical judgement within 72 hours of the procedure, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours of the procedure.
Deterioration of these parameters by other infectious causes (e.g.urinary tract infection) will be excluded.
Measured: From initial intervention to 72 hours after treatment
Clinical Failure at 6 months
Absence of clinical improvement or clinical deterioration
Measured: From initial intervention to the end of followup at 6 months
30-day mortality
Mortality occurring at 30 days after intervention
Measured: From initial intervention to followup at 30 days
Overall total cost of care
Cost of care per patient to achieve overall treatment success
Measured: From initial intervention to the end of followup at 6 months
Overall cost of care at 6 weeks
Cost of care per patient to achieve overall primary outcome
Measured: From initial intervention to followup at 6 weeks
Percent reduction in WON collection volume (cm3) at 6-month follow-up
Percent reduction in overall size of the WON collection volume (cm3) compared to pre-treatment CT or MR imaging.
Measured: From initial intervention to the end of followup at 6 months
Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up
Percent reduction in solid necrosis component of the WON collection volume (cm3) compared to pre-treatment MRI scan.
Measured: From initial intervention to the end of followup at 6 months
Post-procedural length of hospitalization (recovery time)
Length of hospitalization from index intervention to hospital discharge
Measured: From index intervention to hospital discharge at 6 weeks
Readmissions
Number of hospital readmissions due to disease or procedure-related symptoms or events.
Measured: From initial intervention to the end of followup at 6 months
Reintervention rates
Need for endoscopic, radiological, or surgical intervention for additional drainage or necrotic debridement after the index intervention, excluding the follow-up procedure at 4-weeks for LAMS removal
Measured: From initial intervention to the end of followup at 6 months
Requirement of percutaneous drain
Need for additional drainage with percutaneous drain
Measured: From initial intervention to the end of followup at 6 months
Total anesthesia duration
Total duration of anesthesia of primary intervention
Measured: On day of intervention (1 day)
Procedure-related adverse events
Any adverse event resulting from endoscopic intervention (yes/no)
Measured: From initial intervention to the end of followup at 6 months
Disease-related adverse events
Any adverse event resulting from necrotizing pancreatitis
Measured: From initial intervention to the end of followup at 6 months
Patient satisfaction
Patient satisfaction of primary intervention at 6 weeks post intervention graded on a visual analog scale (0-10)
Measured: From initial intervention to the end of followup at 6 months
Subject quality of life (QOL)
Quality of life survey to participants at 6 month follow up. Patients will be asked to place a mark on a horizontal 10 cm line indicating his/her QoL from very poor to very good. The wording will be: "How would you rate your overall quality of life?". Higher score indicates very good quality of life and lower score indicates poor quality of life. The instrument is valid and has been used in clinical trials.
Measured: From initial intervention to the end of followup at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2026Oct 2027

First posted18 Nov 2024
Study startDec 2026 (estimated)
Primary completionMay 2027 (estimated)
Study completionOct 2027 (estimated)

Why it stopped: Lack of funding. No participants enrolled. Study was withdrawn

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Pancreatic NecrosisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: "Endoscopy" arm will receive direct endoscopic necrosectomy and "Surgery" arm will undergo transgastric surgical necrosectomy.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06691919
Sponsor's protocol ID: 78066
Acronym: SERPENT
Status last verified: Apr 2026
First submitted: 13 Nov 2024
Last updated: 24 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 34389094
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.
PubMed 35580661
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.
PubMed 37865281
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.
PubMed 30452918
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.
PubMed 29108721
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.
PubMed 19282306
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.
PubMed 24212912
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.
PubMed 25158913
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.
PubMed 31759037
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.
PubMed 29920619
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.
PubMed 34238810
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.
PubMed 34562471
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.
PubMed 37980922
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.
PubMed 30216220
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.
PubMed 22416101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Not yet recruitingObservational study
Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients
Sepsis, Septic Shock
RecruitingObservational study
DEciphering CIrculating SIgnatures Of Infected Pancreatic Necrosis
Acute Pancreatitis
Recruiting
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
Pancreatic Walled-off Necrosis

All Pancreatic Necrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Surgical vs Endoscopic Resection Of Walled Off Pancreatic Necrosis Using The Powered Endoscopic Debridement (PED) System - The SERPENT Trial
ClinicalTrials.gov ID: NCT06691919
Acronym / sponsor ID: SERPENT / 78066
Conditions: Pancreatic Necrosis, Pancreatitis
Keywords: Direct Endoscopy Necrosectomy, Transgastric Surgical Necrosectomy, Powered Endoscopic Debridement, Pancreatic Necrosis, Walled of Pancreatic Necrosis, Necrotizing Pancreatitis
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of funding. No participants enrolled. Study was withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Indiana University Health
Study start: Dec 2026 (estimated)
Primary completion: May 2027 (estimated)
Study completion: Oct 2027 (estimated)
First posted: 18 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Goal:

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:

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?
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?

Comparison Group:

Participants Will:

Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN).
Undergo the assigned treatment procedure based on their group.
Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction.
Be monitored for adverse events or complications following the treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: "Endoscopy" arm will receive direct endoscopic necrosectomy and "Surgery" arm will undergo transgastric surgical necrosectomy.

Arm	Type	Receives
Direct Endoscopic Necrosectomy	Experimental	Device: Direct Endoscopic Necrosectomy with Powered Endoscopic DebridementSubjects 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).
Transgastric Surgical Necrosectomy	Experimental	Procedure: Transgastric Surgical NecrosectomyPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Direct Endoscopic Necrosectomy with Powered Endoscopic DebridementPatients 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.	Device	Direct Endoscopic Necrosectomy
Transgastric Surgical NecrosectomyPatients 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.	Procedure or surgery	Transgastric Surgical Necrosectomy

Primary outcome

Treatment Success at 6 weeks after Debridement
Time frame: From initial intervention to 6 weeks
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.

17 secondary outcomes

Overall treatment success rate at end of 6-month follow-up from date of intervention
Time frame: From initial intervention to the end of followup at 6 months
Clinical improvement within 72 hours of debridement
Time frame: From initial intervention to 72 hours after treatment
Clinical Failure at 6 months
Time frame: From initial intervention to the end of followup at 6 months
30-day mortality
Time frame: From initial intervention to followup at 30 days
Overall total cost of care
Time frame: From initial intervention to the end of followup at 6 months
Overall cost of care at 6 weeks
Time frame: From initial intervention to followup at 6 weeks
Percent reduction in WON collection volume (cm3) at 6-month follow-up
Time frame: From initial intervention to the end of followup at 6 months
Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up
Time frame: From initial intervention to the end of followup at 6 months
Post-procedural length of hospitalization (recovery time)
Time frame: From index intervention to hospital discharge at 6 weeks
Readmissions
Time frame: From initial intervention to the end of followup at 6 months
Reintervention rates
Time frame: From initial intervention to the end of followup at 6 months
Requirement of percutaneous drain
Time frame: From initial intervention to the end of followup at 6 months
Total anesthesia duration
Time frame: On day of intervention (1 day)
Procedure-related adverse events
Time frame: From initial intervention to the end of followup at 6 months
Disease-related adverse events
Time frame: From initial intervention to the end of followup at 6 months
Patient satisfaction
Time frame: From initial intervention to the end of followup at 6 months
Subject quality of life (QOL)
Time frame: From initial intervention to the end of followup at 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Background: PubMed 34389094Li 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.
Background: PubMed 35580661Onnekink 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.
Background: PubMed 37865281Olsen 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.
Background: PubMed 30452918Bang 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.
Background: PubMed 29108721van 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.
Background: PubMed 19282306Seifert 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.
Background: PubMed 24212912Puli 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.
Background: PubMed 25158913Worhunsky 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.
Background: PubMed 31759037Fugazza 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.
Background: PubMed 29920619van 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.
Background: PubMed 34238810Maatman 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.
Background: PubMed 34562471Stassen 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joo Ha Hwang, MD, PhD principal investigator

Stanford University

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success at 6 weeks after Debridement (time frame: From initial intervention to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06691919, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.