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De klinische studie NCT07253350 (ROTONEC) voor Acute necrotiserende pancreatitis is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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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)

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De klinische studie NCT07253350 (ROTONEC) is een interventioneel studie bij Acute necrotiserende pancreatitis met de status nog niet rekruterend. De inclusie van 64 deelnemers start op 1 november 2025. De studie wordt geleid door Universitaire ziekenhuizen van Groot-Parijs, VS en de voltooiing is gepland op 1 november 2029. Laatste update op ClinicalTrials.gov: 28 november 2025.
Beknopte samenvatting
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.
Officiële titel

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

Aandoeningen
Acute necrotiserende pancreatitis
Andere studie-ID's
  • ROTONEC
  • APHP230816
  • ID-RCB (Overige identificatiecode) (2024-A01139-38)
NCT-ID
NCT07253350
Startdatum (Werkelijk)
2025-11
Laatste update geplaatst
2025-11-28
Verwachte einddatum
2029-11
Inschrijving (Geschat)
64
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
endoscopic necrosectomy
necrotic pancreatic collection
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Enkelblind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelEndorotor Group
DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy.
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.
Actieve comparatorConventional 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
conventionele groep
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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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)

  • 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
Assistance Publique - Hôpitaux de Paris logoUniversitaire ziekenhuizen van Groot-Parijs, VS959 actieve klinische studies om te verkennen
Centraal Contactpersoon
Contact: Frederic Prat, MD PHD, 01 40 87 56 63, [email protected]
Contact: Diane Lorenzo, MD PHD, 01 40 87 56 63, [email protected]
1 Studielocaties in 1 landen
Hospital Beaujon, APHP, Clichy, France
Frederic Prat, MD PHD, Contact, 01 40 87 56 63, [email protected]