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

NCT01855841 | Completed Phase 2

• 1 other identifier: Hemin_AP
• Study Type: interventional
• Target: 284
• Locations: 2 countries
• Sites: 6

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.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

ERCP; virgin papilla; risk of post-ERCP acute pancreatitis

Outcome Measures

Primary Outcomes (1)

• Incidence of post-ERCP acute pancreatitis

  Post-ERCP acute pancreatitis is defined by an abdominal pain compatible with pancreatitis and the elevation of seric lipases more than 3 times the upper limit of normal on days 1 post-ERCP.

  at day 1 post-ERCP

Secondary Outcomes (3)

• severity of post-ERCP acute pancreatitis

  during the hospital stay (up to 2 months)

• length of stay

  during the hospitalization (up to 2 months)

• safety of hemin administration

  within 7 days

Other Outcomes (1)

• number of patients with post-ERCP acute pancreatitis and adverse event at interim analysis

  after 100 patients

Study Arms (2)

Hemin

ACTIVE COMPARATOR

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

Drug: Hemin

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Hemin 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

Also known as: Haemin, Normosang

Hemin

placebo 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

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (6)

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme Hospital, Université Libre de Bruxelles (ULB)

Brussels, 1070, Belgium

Location

Centre Hospitalier de Jolimont-Lobbes

Haine-St-Paul, 7100, Belgium

Location

Hôpital Ambroise Paré

Mons, 7000, Belgium

Location

ISPPC CHU Vésale

Montigny-le-Tilleul, 6110, Belgium

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38431445 DERIVED

MeSH Terms

Interventions

Hemin; Heme; heme arginate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Metalloporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Arnaud Lemmers, MD,PhD

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

  PRINCIPAL INVESTIGATOR

• Jacques Devière, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 17, 2013
• Study Start: April 1, 2012
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

BE (5); TW (1)