Clinical trial NCT02739074: Effectiveness of Metal Protheses Covered in "Diabolo" in Treatment of Necrosis of Origin Pancreatic: Trial "DIABOLOPIG"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of patients who complete treatment of pancreatic necrosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Geoffroy VANBIERVLIET, Dr
role: STUDY_DIRECTOR
References: