Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717599
Recruitment Status : Unknown
Verified October 2012 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : October 30, 2012
Last Update Posted : October 30, 2012
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Pancreatitis is one of the major complications of ERCP. It has been shown that NSAIDs are potent inhibitors of phospholipase A2, activity which is increased in pancreatitis. The only one study with IM diclofenac showed reduction of post-ERCP pancreatitis without SOD (sphincter of Oddi dysfunction) by subgroup analysis in small study population. Therefore the investigators must need large scaled randomized control study including of SOD.

Condition or disease Intervention/treatment Phase
Post ERCP Pancreatitis Drug: Diclofenac Drug: normal saline Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : August 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Diclofenac group Drug: Diclofenac
Diclofenac 90mg, 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

Placebo Comparator: Placebo(normal saline) group Drug: normal saline
normal saline 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

Primary Outcome Measures :
  1. Incidence of post ERCP pancreatitis [ Time Frame: 24hours after the procedure(ERCP) ]
    Acute pancreatitis was defined as serum amylase at least three times the upper limit of normal range 24hours after the procedure associated with new or increased upper abdomen or epigastric pain, back pain, and epigastric tenderness and hospitalization or prolongation of existing hospitalization for at least 2 nights.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years.

Exclusion Criteria:

Patients were excluded from study participation if:

  • they had a contraindication for diclofenac,
  • including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks,
  • renal failure (Cr > 1.4),
  • those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable),
  • those who developed acute pancreatitis during the 2 weeks before ERCP,
  • those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and
  • those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717599

Contact: Moon Jae Chung, MD 82-2-2228-1981

Korea, Republic of
Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Moon Jae Chung, MD    82-2-2228-1981   
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01717599     History of Changes
Other Study ID Numbers: 4-2012-0466
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

Keywords provided by Yonsei University:
Post ERCP pancreatitis

Additional relevant MeSH terms:
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action