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

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasme University Hospital

Criteria

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)