Hospital Beaujon, APHP
Clichy, France
Location status: Recruiting
NCT Number: NCT07253350
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Clichy, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
Time frame: 10 month
Time frame: 10 month
Time frame: 10 month
Time frame: 10 month
Time frame: 10 month
Time frame: 10 month
Time frame: 4 month
Time frame: 4 month
Time frame: 4 month
Time frame: 4 month
Time frame: 16 month
Time frame: 4 month
Time frame: 4 month
Time frame: 4 month
Time frame: 4 month
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).
Time frame: 4 month
Failure types and number of occurrences
Time frame: 16 month
Time frame: 16 month
Time frame: 16 month
Time frame: 16 month
EQ-5D-5L score at the end of hospitalization and during follow-up's visits
Time frame: 16 month
Contact information is provided by the study sponsor or research team.
Diane Lorenzo, MD PHD
CONTACT
01 40 87 56 63 ext. +33
Frederic Prat, MD PHD
CONTACT
01 40 87 56 63 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ROTONEC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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