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Clinical Trials/EUCTR2011-000397-59-BE
EUCTR2011-000397-59-BE
Active, not recruiting
Not Applicable

Prevention of post-ERCP acute pancreatitis by heme-oxygenase activation through the administration of hemin: a prospective, randomized double blind controlled trial. - Hemin to prevent post-ERCP acute pancreatitis

Not provided0 sites294 target enrollmentFebruary 23, 2011
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ConditionsPrevention of post-ERCP acute pancreatitis.So, patient with indications of ERCP (endoscopic retrograde cholangiopanreatography) will be included. These patients suffer from bilio-pancreatic disorders.
DrugsNormosang (hemin)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
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.
Sponsor
Not provided
Enrollment
294
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 23, 2011
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility 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

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
  • •allergy to hemin
  • •renal failure (creatininemia\>2mg/dl)

Outcomes

Primary Outcomes

Not specified

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