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

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ClinicalTrials.gov Identifier: NCT02739074
Recruitment Status : Unknown
Verified March 2016 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Pancreatic Diseases

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of patients who complete treatment of pancreatic necrosis [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739074


Contacts
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Contact: Geoffroy VANBIERVLIET, Dr vanbiervliet.g@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, France, 06000
Contact: Geoffroy VANBIERVLIET, Dr       vanbiervliet.g@chu-nice.fr   
Principal Investigator: Geoffroy VANBIERVLIET, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Study Director: Geoffroy VANBIERVLIET, Dr Centre Hospitalier Universitaire de Nice

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02739074    
Other Study ID Numbers: 15-PP-01
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Pancreatic Diseases
Digestive System Diseases