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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02739074

Acronym

DIABOLOPIG

Enrollment

Registered

2016-04-14

Start date

2016-03-25

Completion date

2021-11-02

Last updated

2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results