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Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

This study is currently recruiting participants.
Verified October 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01717599
First received: October 25, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Post ERCP Pancreatitis
 Drug: Diclofenac
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of post ERCP pancreatitis [ Time Frame: 24hours after the procedure(ERCP) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 380
Study Start Date: August 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717599

Contacts
Contact: Moon Jae Chung, MD 82-2-2228-1981 mjchung@yuhs.ac

Locations
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     mjchung@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01717599     History of Changes
Other Study ID Numbers: 4-2012-0466
Study First Received: October 25, 2012
Last Updated: October 29, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Post ERCP pancreatitis
Diclofenac
NSAID

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

ClinicalTrials.gov processed this record on June 17, 2013