Post-ERCP Acute Pancreatitis
Conditions
Keywords
ERCP, virgin papilla, risk of post-ERCP acute pancreatitis
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.
Interventions
DRUGHemin
A single perfusion of 4mg/kg hemin diluted in 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
DRUGplacebo
A single perfusion of 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-ERCP acute pancreatitis | at day 1 post-ERCP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| severity of post-ERCP acute pancreatitis | during the hospital stay (up to 2 months) | 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?) |
| length of stay | during the hospitalization (up to 2 months) | the length of stay in the hospital will be recorded. if a complication occurs (post-ERCP acute pancreatitis or other, it will be recorded) |
| safety of hemin administration | within 7 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of patients with post-ERCP acute pancreatitis and adverse event at interim analysis | after 100 patients | 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) |
Countries
Belgium, Taiwan
Outcome results
None listed