Acute Necrotizing PancreatitisROTONECNCT07253350
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
A study testing Endorotor Group and Conventional group in people with Acute Necrotizing Pancreatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Necrotizing Pancreatitis
- What is being tested?
- Endorotor Group and Conventional group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2026to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Beaujon, APHP
Clichy
Frederic Prat, MD PHD, 01 40 87 56 63 ext. +33, frederic.prat@aphp.fr
About this study
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.
- Conditions
- Acute Necrotizing Pancreatitis
- Being tested
- Endorotor Group, Conventional group
- Keywords
- endoscopic necrosectomy, necrotic pancreatic collection
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorotor GroupDevice
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.
Conventional groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Endorotor Group | Experimental | DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. Receives: Device: Endorotor Group |
| Conventional group | Active comparator | 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 Receives: Other: Conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 month
Secondary outcomes (21)
number of death
Measured: 10 month
number of new-onset multiple organ failure
Measured: 10 month
number of visceral perforation
Measured: 10 month
number of arterial perforation
Measured: 10 month
number of pancreatic-cutaneous fistulas
Measured: 10 month
number of sepsis
Measured: 10 month
number of abscess
Measured: 4 month
number of Bleeding of any severity
Measured: 4 month
number of Need for surgery (video-assisted retroperitoneal debridement or open surgery)
Measured: 4 month
number of Need for "multigate" strategy with the installation of a percutaneous drain
Measured: 4 month
time to total recovery of acute pancreatitis
Measured: 16 month
Total time of all DEN sessions in minutes
Measured: 4 month
Total number of DEN sessions
Measured: 4 month
Number of days of antibiotic treatment
Measured: 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).
Measured: 4 month
number of issues with Endorotor PED® device
Failure types and number of occurrences
Measured: 4 month
Number of days of hospitalization: In intensive care unit
Measured: 16 month
Number of days of hospitalization: In conventional unit
Measured: 16 month
Number of days of hospitalization in rehabilitation unit
Measured: 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
Measured: 16 month
Total hospital costs in acute care per patient Endorotor
Measured: 16 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Jan 2026
- Primary completionMar 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- frederic Prat, MD PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253350
- Sponsor's protocol ID
- APHP230816
- Other IDs
- ID-RCB
- Acronym
- ROTONEC
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07253350
- Acronym / sponsor ID
- ROTONEC / APHP230816
- Conditions
- Acute Necrotizing Pancreatitis
- Keywords
- endoscopic necrosectomy, necrotic pancreatic collection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 28 Nov 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endorotor Group | Experimental | Device: Endorotor GroupDEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. |
| Conventional group | Active comparator | Other: Conventional groupDEN 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Endorotor GroupDEN 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. | Device | Endorotor Group |
| Conventional groupDEN 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 |
Primary outcome
evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis.
Time frame: 5 month
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.
21 secondary outcomes
number of death
Time frame: 10 month
number of new-onset multiple organ failure
Time frame: 10 month
number of visceral perforation
Time frame: 10 month
number of arterial perforation
Time frame: 10 month
number of pancreatic-cutaneous fistulas
Time frame: 10 month
number of sepsis
Time frame: 10 month
number of abscess
Time frame: 4 month
number of Bleeding of any severity
Time frame: 4 month
number of Need for surgery (video-assisted retroperitoneal debridement or open surgery)
Time frame: 4 month
number of Need for "multigate" strategy with the installation of a percutaneous drain
Time frame: 4 month
time to total recovery of acute pancreatitis
Time frame: 16 month
Total time of all DEN sessions in minutes
Time frame: 4 month
Total number of DEN sessions
Time frame: 4 month
Number of days of antibiotic treatment
Time frame: 4 month
operative difficulty of DEN assessed by endoscopists
Time frame: 4 month
number of issues with Endorotor PED® device
Time frame: 4 month
Number of days of hospitalization: In intensive care unit
Time frame: 16 month
Number of days of hospitalization: In conventional unit
Time frame: 16 month
Number of days of hospitalization in rehabilitation unit
Time frame: 16 month
quality of life of patients during and after hospitalization
Time frame: 16 month
Total hospital costs in acute care per patient Endorotor
Time frame: 16 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
frederic Prat, MD PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endorotor Group and Conventional group in people with Acute Necrotizing Pancreatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederic Prat, MD PHD (01 40 87 56 63 ext. +33, frederic.prat@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis. (time frame: 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.