Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Yonsei University.
Recruitment status was Recruiting
Information provided by (Responsible Party):
First received: October 25, 2012
Last updated: October 29, 2012
Last verified: October 2012
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.
Post ERCP Pancreatitis
Drug: normal saline
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Experimental: Diclofenac group
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
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01717599
|Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
|Seoul, Korea, Republic of, 120-752 |
|Contact: Moon Jae Chung, MD 82-2-2228-1981 firstname.lastname@example.org |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2012
||October 29, 2012
||Korea: Institutional Review Board
Keywords provided by Yonsei University:
Post ERCP pancreatitis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2014
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents