Post-ERCP Acute Pancreatitis Clinical Trial
Official title:
Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial
NCT number | NCT01855841 |
Other study ID # | Hemin_AP |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | June 2021 |
Verified date | July 2021 |
Source | Erasme University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 284 |
Est. completion date | June 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Brugmann | Brussels | |
Belgium | Erasme Hospital, Université Libre de Bruxelles (ULB) | Brussels | |
Belgium | Centre Hospitalier de Jolimont-Lobbes | Haine-St-Paul | |
Belgium | Hôpital Ambroise Paré | Mons | |
Belgium | ISPPC CHU Vésale | Montigny Le tilleul | |
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital |
Belgium, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | number of patients with post-ERCP acute pancreatitis and adverse event at interim analysis | After having randomized 50 patients by arm, an interim analysis will be conducted to evaluate the safety (superficial venous thrombophlebitis, headache, unexpected adverse events)and need to complete the study (depending on the results on post-ERCP acute pancreatitis incidence) | after 100 patients | |
Primary | 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 | severity of post-ERCP acute pancreatitis | If post-ERCP acute pancreatitis happens, all parameters of severity will be recorded (clinical, biological, intra-abdominal collections seen on abdominal scanner/magnetic resonance, organ failure, need for ICU hospitalization, need for further treatment: surgery/endoscopy/radiological drainage?) | during the hospital stay (up to 2 months) | |
Secondary | length of stay | the length of stay in the hospital will be recorded. if a complication occurs (post-ERCP acute pancreatitis or other, it will be recorded) | during the hospitalization (up to 2 months) | |
Secondary | safety of hemin administration | Few side effects of hemin are known (headache, superficial thrombophlebitis in the perfused vein); they will be recorded as well as other unexplained clinico-biological events | within 7 days |
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