DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 pancreatitis

length 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017