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

NCT ID: NCT01855841

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2021-06-30

Brief 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.

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.

Conditions

Post-ERCP Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Hemin

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

Group Type: ACTIVE_COMPARATOR

Hemin

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Haemin; Normosang; saline

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lemmers Arnaud

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnaud Lemmers, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium

Jacques Devière, MD, PhD

Role: STUDY_CHAIR

Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium

Locations

CHU Brugmann

Brussels, , Belgium

Erasme Hospital, Université Libre de Bruxelles (ULB)

Brussels, , Belgium

Centre Hospitalier de Jolimont-Lobbes

Haine-St-Paul, , Belgium

Hôpital Ambroise Paré

Mons, , Belgium

ISPPC CHU Vésale

Montigny-le-Tilleul, , Belgium

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Belgium; Taiwan

References

Yared RA, Chen CC, Vandorpe A, Arvanitakis M, Delhaye M, Viesca MFY, Huberty V, Blero D, Toussaint E, Hittelet A, Verset D, Margos W, Le Moine O, Njimi H, Liao WC, Deviere J, Lemmers A. Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial. Pancreatology. 2024 May;24(3):363-369. doi: 10.1016/j.pan.2024.02.009. Epub 2024 Feb 15.

Reference Type: DERIVED

PMID: 38431445 (View on PubMed)

Other Identifiers

Hemin_AP

Identifier Type: -

Identifier Source: org_study_id