Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis (ROTONEC)

This is a national single-blinded prospective multicenter randomized (1:1) controlled trial, with two parallel arms, using a PROBE methodology, including patients with complicated acute necrotizing pancreatitis who require DEN of WON collection after endoscopic drainage. We will compare 2 groups: conventional DEN and DEN with Endorotor®. The study will be offered to all consecutive patients fulfilling the eligibility criteria after endoscopic drainage for WON. Since the time between drainage and the first necrosectomy session is usually at least 48 hours a period of at least 24h will be allowed for the patient to consider options to participate or not. Information and collection of informed consent will be done by an investigating physician.

Study Overview

• Status: Recruiting
• Conditions: Acute Necrotizing Pancreatitis
• Intervention / Treatment: Device: Endorotor Group; Other: Conventional group

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frederic Prat, MD PHD; Phone Number: +33 01 40 87 56 63; Email: frederic.prat@aphp.fr
• Study Contact Backup: Name: Diane Lorenzo, MD PHD; Phone Number: +33 01 40 87 56 63; Email: diane.lorenzo@gmail.com

Study Locations

• France
  • Clichy, France
    • Recruiting
    • Hospital Beaujon, APHP
    • Contact: Frederic Prat, MD PHD; Phone Number: +33 01 40 87 56 63; Email: frederic.prat@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age≥18years
• ASA<5
• CT scan less than 7 days old
• Hospitalized for acute necrotizing pancreatitis, whatever the cause, and who have undergone drainage of pancreatic collections for the following indications according to the revised Atlanta criteria (infection, organ compression, persistent organ failure)
• Have need for at least one DEN session despite endoscopic drainage (persistence of clinical symptoms or sepsis >48h after drainage with collection still visible)

Exclusion Criteria:

• No endoscopic drainage in place for the management of WON
• Have already had a DEN session (endoscopic or else) before screening for inclusion
• Life-expectancy < 1year (advanced cancer, etc)
• Known haemostasis disorder (chronic thrombocytopenia, haemophilia, etc.)
• Pregnant or breastfeeding woman
• Subject deprived of freedom, subject under a legal protective measure
• Non-affiliation to a social security regimen or CMU
• Patient or person of confidence (if present at the time of inclusion) opposing the patient's participation in research
• Subject already involved in another interventional clinical research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endorotor Group; DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy.	Device: Endorotor Group; DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. Endorotor 3.2 is slimmer and enters WON more easily when the transgastric access is located in the upper portion of the stomach). If needed: lavage, aspiration and conventional mechanical debridement could be used in addition during an ENDOROTOR-based DEN session.
Active Comparator: Conventional group; DEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis	Other: Conventional group; DEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis.	The effectiveness of the operative approach (Endorotor 3.2/PED® or conventional technique) will be assessed by the period in days between the first DEN session and the confirmed complete necrosis resolution.	5 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of death		10 month
number of new-onset multiple organ failure		10 month
number of visceral perforation		10 month
number of arterial perforation		10 month
number of pancreatic-cutaneous fistulas		10 month
number of sepsis		10 month
number of abscess		4 month
number of Bleeding of any severity		4 month
number of Need for surgery (video-assisted retroperitoneal debridement or open surgery)		4 month
number of Need for "multigate" strategy with the installation of a percutaneous drain		4 month
time to total recovery of acute pancreatitis		16 month
Total time of all DEN sessions in minutes		4 month
Total number of DEN sessions		4 month
Number of days of antibiotic treatment		4 month
operative difficulty of DEN assessed by endoscopists	A Likert score will be used to assess the ease of use to maneuver device by endoscopist, from 0 (most difficult surgery imaginable) to 10 (easiest).	4 month
number of issues with Endorotor PED® device	Failure types and number of occurrences	4 month
Number of days of hospitalization: In intensive care unit		16 month
Number of days of hospitalization: In conventional unit		16 month
Number of days of hospitalization in rehabilitation unit		16 month
quality of life of patients during and after hospitalization	EQ-5D-5L score at the end of hospitalization and during follow-up's visits	16 month
Total hospital costs in acute care per patient Endorotor		16 month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: frederic Prat, MD PHD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: endoscopic necrosectomy; necrotic pancreatic collection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: APHP230816; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No