ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be effective in multiple bilio-pancreatic indications. However, one of the feared complication of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient groups have been demonstrated to present a higher risk linked to individual factors or to the procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the incidence of this complication but each has his own inconvenient. Recently, the activation of heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be effective in prevention and treatment of acute pancreatitis mice models. This protective effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated by hemin. The investigators thus propose to conduct a prospective randomized double blind controlled trial to demonstrate a protective effect of hemin administration against post-ERCP acute pancreatitis in high risk patients.

Brief Title

Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis

Official Title

Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial

Brief Summary

ERCP (endoscopic retrograde cholangiopancreatography) has been largely demonstrated to be <br /> effective in multiple bilio-pancreatic indications. However, one of the feared complication <br /> of this technique is acute pancreatitis, which happens in 5 to 25% of cases. Some patient <br /> groups have been demonstrated to present a higher risk linked to individual factors or to the <br /> procedure. Some interventions (endoscopic or pharmacologic) have been evaluated to reduce the <br /> incidence of this complication but each has his own inconvenient. Recently, the activation of <br /> heme oxygenase (HO) by intraperitoneal administration of hemin has been demonstrated to be <br /> effective in prevention and treatment of acute pancreatitis mice models. This protective <br /> effect has been associated to intrapancreatic HO-1 positive macrophage recruitment activated <br /> by hemin. The investigators thus propose to conduct a prospective randomized double blind <br /> controlled trial to demonstrate a protective effect of hemin administration against post-ERCP <br /> acute pancreatitis in high risk patients.

Detailed Description

Patients for who a pancreatic stent placement is indicated will be excluded from the study.

The aims of this study are: 1) to study in a pathophysiologic point of view the activation of
HO-1 by hemin in human and its protective effect in post-ERCP acute pancreatitis incidence.
2) to use the human situation of post-ERCP acute pancreatitis as early pancreatitis model to
study the administration of hemin as treatment of acute pancreatitis in general.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Inclusion Criteria: one or more factors of >10% post-ERCP acute pancreatitis risk:

  -  former episode of acute pancreatitis

  -  former episode of post-ERCP acute pancreatitis

  -  normal bilirubin level

  -  main pancreatic duct injection

  -  endoscopic biliary sphincteroplasty (balloon dilation of biliary sphincter)

  -  precut papillotomy

  -  pancreatic sphincterotomy

Exclusion Criteria:

  -  patient for whom a pancreatic stent is inserted (Sphincter of Oddi dysfunction,
     ampullectomy)

  -  ongoing acute pancreatitis

  -  chronic pancreatitis (Cremer classification >=2)

  -  age < 18 y/o

  -  pregnancy

  -  hemin allergy

  -  severe renal failure (MDRD<30ml/min/1.73m2)