Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis
Information source: Erasme University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-ERCP Acute Pancreatitis
Intervention: Hemin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Erasme University Hospital Official(s) and/or principal investigator(s): Arnaud Lemmers, MD,PhD, Principal Investigator, Affiliation: Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium Jacques Devière, MD, PhD, Study Chair, Affiliation: Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium
Overall contact: Arnaud Lemmers, MD, PhD, Phone: +3225556559, Email: arnaud.lemmers@erasme.ulb.ac.be
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.
Clinical Details
Official title: Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Incidence of post-ERCP acute pancreatitis
Secondary outcome: severity of post-ERCP acute pancreatitislength of stay safety of hemin administration
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Arnaud Lemmers, MD, PhD, Phone: +3225556559, Email: arnaud.lemmers@erasme.ulb.ac.be
CHU Brugmann, Brussels 1020, Belgium; Recruiting emmanuel Toussaint, MD, Phone: 3224772111, Email: Emmanuel.TOUSSAINT@chu-brugmann.be Emmanuel Toussaint, MD, Principal Investigator
Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels 1070, Belgium; Recruiting Arnaud Lemmers, MD, PhD, Phone: +3225556559, Email: arnaud.lemmers@erasme.ulb.ac.be Mohammed Amrani, Phone: +3225558382, Email: mohammed.amrani@erasme.ulb.ac.be Arnaud Lemmers, MD, PhD, Principal Investigator Olivier Le Moine, MD, PhD, Sub-Investigator Jacques Devière, MD, PhD, Sub-Investigator Myriam Delhaye, MD, PhD, Sub-Investigator Marianna Arvanitakis, MD, PhD, Sub-Investigator
Centre Hospitalier de Jolimont-Lobbes, Haine-St-Paul 7100, Belgium; Recruiting Didier Verset, MD, Phone: +32 478 421 493, Email: didier.verset@skynet.be Didier Verset, MD, Principal Investigator
Hôpital Ambroise Paré, Mons 7000, Belgium; Recruiting Axel Hittelet, MD, Phone: 065.39.37.48, Email: axel.hittelet@hap.be Axel Hittelet, MD, Principal Investigator
ISPPC CHU Vésale, Montigny Le tilleul 6110, Belgium; Recruiting Daniel Blero, MD, PhD, Phone: +3271922268, Email: daniel.blero@chu-charleroi.be Daniel Blero, MD, PhD, Principal Investigator
Policlinico Gemelli Universita Cattolica, Rome 00168, Italy; Not yet recruiting Guido Costamagna, MD, Phone: 06.35511515, Email: gcostamagna@rm.unicatt.it Guido Costamagna, MD, Principal Investigator Andrea Tringali, MD, Sub-Investigator
Additional Information
Starting date: April 2012
Last updated: February 27, 2015
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