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Post ERCP Pancreatitis | Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

Post ERCP Pancreatitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post ERCP Pancreatitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DiclofenacDiclofenac 90mg, 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Diclofenac group

Placebo(normal saline) group

Study Status

Unknown status

Start Date: August 2012

Completed Date: October 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Incidence of post ERCP pancreatitis

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Yonsei University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01717599

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