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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 2

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: placebo; Drug: Hemin

Study type: Interventional

Funder types: Other

Identifiers

NCT01855841

Hemin_AP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups, including a placebo group

Hemin

Active Comparator group

Description:

A peripheral perfusion of 4mg/kg of hemin (Normosang) diluted in 100mL NaCL (sodium chloride) 0.9% will be administered in 30-60minutes as soon as possible after the end of the ERCP, followed by 100mL of NacL 0.9% to flush the vein

Treatment:

Drug: Hemin

Placebo

Placebo Comparator group

Description:

The same amount of NaCl 0.9% (100 ML followed by a flushing perfusion of 100mL) will be perfused to the patient as soon as possible after the end of the ERCP

Treatment:

Drug: placebo