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

NCT02739074 | Completed

• 1 other identifier: 15-PP-01
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Diseases

Outcome Measures

Primary Outcomes (1)

• Rate of patients who complete treatment of pancreatic necrosis

  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.

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Recruitment is in hospital, all patients being hospitalized in case of complicated pancreatic necrosis requiring treatment. The treatment will be done like habitually by using a Diabolo prothesis. Investigators physicians will all doctors gastro enterology experts in interventional endoscopy supports daily basis patients with acute pancreatitis. Further investigation centers are tertiary referral centers authorized to support acute complicated pancreatitis.

You may qualify if:

• 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)

You may not qualify if:

• Severe coagulation disorders or hemostasis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Geoffroy VANBIERVLIET, Dr

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 14, 2016
• Study Start: March 25, 2016
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: March 28, 2023

Record last verified: 2016-03

Locations

FR (1)