Intramuscular Diclofenac in the Prevention of Post-ERCP Pancreatitis

NCT01717599 | Completed

• 1 other identifier: 4-2012-0466
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Post ERCP Pancreatitis

Keywords

Post ERCP pancreatitis; Diclofenac; NSAID

Outcome Measures

Primary Outcomes (1)

• Incidence of post ERCP pancreatitis

  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.

  24hours after the procedure(ERCP)

Study Arms (2)

Diclofenac group

EXPERIMENTAL

Drug: Diclofenac

Placebo(normal saline) group

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Diclofenac DRUG

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

Diclofenac group

normal saline DRUG

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

Placebo(normal saline) group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Park SW, Chung MJ, Oh TG, Park JY, Bang S, Park SW, Song SY. Intramuscular diclofenac for the prevention of post-ERCP pancreatitis: a randomized trial. Endoscopy. 2015 Jan;47(1):33-9. doi: 10.1055/s-0034-1390743. Epub 2014 Nov 19.

  PMID: 25409167 DERIVED

MeSH Terms

Interventions

Diclofenac; Saline Solution

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 30, 2012
• Study Start: August 29, 2012
• Primary Completion: August 28, 2013
• Study Completion: August 28, 2013
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

KR (1)