Status:
COMPLETED
Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis
Lead Sponsor:
Erasme University Hospital
Conditions:
Post-ERCP Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT01855841
Start Date
April 1 2012
End Date
June 1 2021
Last Update
July 7 2021
Active Locations (6)
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1
CHU Brugmann
Brussels, Belgium, 1020
2
Erasme Hospital, Université Libre de Bruxelles (ULB)
Brussels, Belgium, 1070
3
Centre Hospitalier de Jolimont-Lobbes
Haine-St-Paul, Belgium, 7100
4
Hôpital Ambroise Paré
Mons, Belgium, 7000