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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
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
Hospital Beaujon, APHP
Clichy, France
RECRUITINGevaluate 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.
Time frame: 5 month
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
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
number of issues with Endorotor PED® device
Failure types and number of occurrences
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
EQ-5D-5L score at the end of hospitalization and during follow-up's visits
Time frame: 16 month
Total hospital costs in acute care per patient Endorotor
Time frame: 16 month
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