Prevention of post-ERCP acute pancreatitis by heme-oxygenase activation through the administration of hemin: a prospective, randomized double blind controlled trial. - Hemin to prevent post-ERCP acute pancreatitis

Conditions: Prevention of post-ERCP acute pancreatitis.So, patient with indications of ERCP (endoscopic retrograde cholangiopanreatography) will be included. These patients suffer from bilio-pancreatic disorders.

Registration Number: EUCTR2011-000397-59-BE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 294

Inclusion Criteria

one of the following:
- clinical criteria:
1) past history of acute pancreatitis
2) past history of post-ERCP acute pancreatitis
3) normal serum bilirubin range
- technical criteria:
1) injection of the main pancreatic duct
2) biliary sphincteroplasty
3) papillotomy (precut)
4) pancreatic sphincterotomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

placement of a prophylactic pancreatic stent:
-sphincter of Oddi dysfunction
-ampullectomy
ongoing acute pancreatitis
known chronic pancreatitis (>grade 2 following cremer classification)
youger than 18 y/o
pregnancy
allergy to hemin
renal failure (creatininemia>2mg/dl)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: demonstrate a reduction in the incidence of post-ERCP acute pancreatitis;Secondary Objective: 1)modulation of the severity of post-ERCP acute pancreatitis<br>2)modulation in the length of stay in the hospital, <br>3)safety data collection, <br>4)quantification of heme oxygenase induction at 24 hours.;Primary end point(s): demonstrate a reduction in the incidence of post-ERCP acute pancreatitis.<br>definition: epigastric pain associated to an elevation of serum lipase level more than 3 times the upper limit of normal.

Secondary Outcome Measures