Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG"

Completed

• Conditions: Pancreatic Diseases

• Registration Number: NCT02739074
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Endoscopic treatment of pancreatic necrosis complicated by trans digestive track (duodenal or gastric) has become a standard technique validated. The rate of high technical and clinical success (76 to 91% in 3 months) and the lower morbidity in the literature explains that validation. However this treatment is done at the cost of a higher median number of treatment sessions (4-5) explaining prolonged hospitalization, delays in rehabilitation and potentially high costs. The constant improvement of therapeutic endoscopy equipment was allowed to see the advent of metal prosthesis completely covered by a membrane allowing them endoscopic extraction with ease. It has thus been recently developed short prostheses, of large diameter (up to 15/16 mm), with broad flange (or stent "diabolo") to be considered for use in the drainage of digestive peri collections. Few studies respectively determined the effectiveness of this type of prosthesis in the drainage of peri digestive collections Under echo endoscopy and treatment of necrosis of pancreatic origin. The purpose of this work is to evaluate multicenter prospective clinical and technical efficiency of laying completely covered stent "diabolo" in echo endoscopy for the treatment of necrosis of pancreatic origin.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03-25
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Primary Completion: 2021-11-02
• Study Completion: 2021-11-02
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Presence of peri gastric or duodenal collection type WOPN to imaging according to the Atlanta criteria (Banks Gut 2013) with predominantly solid component (> 50%) for imaging, requiring necrosectomy for:

• Pain and / or,
• necrosis infection (positive necrosis culture, gas bubble presence in the collection on imaging, persistent sepsis or deterioration of the patient's condition despite optimal reanimation support without documented infection) and / or,
• High Occlusion (vomiting, food intolerance and gastric stasis at imaging)

Exclusion Criteria

• Severe coagulation disorders or hemostasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patients who complete treatment of pancreatic necrosis	3 months	Rate of patients who complete treatment of pancreatic necrosis was obtained (\> 80% and amendment of symptoms) after a single necrosectomy endoscopic session with a covered metal prosthesis.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France