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

NCT01855841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-07-07

No results posted yet for this study

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.

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Hemin

A single perfusion of 4mg/kg hemin diluted in 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein

DRUG

placebo

A single perfusion of 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Arnaud Lemmers, MD,PhD · Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium

  • Jacques Devière, MD, PhD · Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2021-06-01
Completion
2021-06-30

Countries

  • Belgium
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855841 on ClinicalTrials.gov