Prevention of post-ERCP acute pancreatitis. So, patient with indications of ERCP (endoscopic retrograde cholangiopanreatography) will be included. These patients suffer from bilio-pancreatic disorders.
Conditions
Interventions
Trade Name: Normosang (hemin)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: none
CAS Number: 16009135
Current Sponsor code: none
Other descriptive name: HEMIN
Concentration unit: mg/
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: one of the following: - clinical criteria: 1) past history of acute pancreatitis 2) past history of post-ERCP acute pancreatitis 3) normal serum bilirubin range - technical criteria: 1) injection of the main pancreatic duct 2) biliary sphincteroplasty 3) papillotomy (precut) 4) pancreatic sphincterotomy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: placement of a prophylactic pancreatic stent: -sphincter of Oddi dysfunction -ampullectomy ongoing acute pancreatitis known chronic pancreatitis (>grade 2 following cremer classification) youger than 18 y/o pregnancy allergy to hemin renal failure (creatininemia>2mg/dl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: demonstrate a reduction in the incidence of post-ERCP acute pancreatitis;Secondary Objective: 1)modulation of the severity of post-ERCP acute pancreatitis 2)modulation in the length of stay in the hospital, 3)safety data collection, 4)quantification of heme oxygenase induction at 24 hours.;Primary end point(s): demonstrate a reduction in the incidence of post-ERCP acute pancreatitis. definition: epigastric pain associated to an elevation of serum lipase level more than 3 times the upper limit of normal. | — |
Countries
Belgium
Outcome results
None listed