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NCT Number: NCT01855841

Hemin to Prevent Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) Acute Pancreatitis

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.

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Key information

Conditions

Post-ERCP Acute Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Brugmann, Brussels, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hemin

Drug

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

Other names: Haemin, Normosang

Placebo

Drug

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

Other names: saline

Primary outcomes

  1. Incidence of post-ERCP acute pancreatitis

    Time frame: 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 outcomes

  1. severity of post-ERCP acute pancreatitis

    Time frame: 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?)

  2. length of stay

    Time frame: 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)

  3. safety of hemin administration

    Time frame: 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 outcomes

  1. number of patients with post-ERCP acute pancreatitis and adverse event at interim analysis

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Prevention of Post-ERCP Acute Pancreatitis by Heme-oxygenase Activation Through the Administration of Hemin : a Prospective, Randomized Double Blind Controlled Trial

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
May 17, 2013
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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