Clinical trial NCT01855841: Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-ERCP Acute Pancreatitis
Keywords: ERCP
virgin papilla
risk of post-ERCP acute pancreatitis
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Incidence of post-ERCP acute pancreatitis
timeFrame: at day 1 post-ERCP
Secondary outcomes:
measure: severity of post-ERCP acute pancreatitis
timeFrame: during the hospital stay (up to 2 months)
measure: length of stay
timeFrame: during the hospitalization (up to 2 months)
measure: safety of hemin administration
timeFrame: within 7 days
Other outcomes:
measure: number of patients with post-ERCP acute pancreatitis and adverse event at interim analysis
timeFrame: after 100 patients
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Erasme Hospital, Université Libre de Bruxelles (ULB)
city: Haine-St-Paul
country: Belgium
facility: Centre Hospitalier de Jolimont-Lobbes
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Montigny Le tilleul
country: Belgium
facility: ISPPC CHU Vésale
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Erasme Hospital, Université libre de Bruxelles (ULB), Brussels, Belgium
name: Arnaud Lemmers, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Blegium
name: Jacques Devière, MD, PhD
role: STUDY_CHAIR
References: