Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis

NCT01946984 | Completed Phase 1 DMC

• 1 other identifier: Specialized Arab Hospital
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
2. 2.Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
3. 3.The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
4. 4.The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.

Conditions

Post-ERCP Acute Pancreatitis.

Keywords

diclofenac, ERCP and pancreatitis

Outcome Measures

Primary Outcomes (1)

• prevention of pancreatitis,

  1. Patients with epigastric pain, back pain, and epigastric tenderness, 2. And all had serum amylase measured after the procedure, if elevated more than 3 folds of normal, the patient was diagnosed to have post ERCP pancreatitis,

  within a week after procedure

Study Arms (2)

Diclofenac,75 mg, 3 ml,

ACTIVE COMPARATOR

patients were given Diclofenac IM before ERCP.

Procedure: ERCP; Drug: Diclofenac hydroxyethylpyrrolidine

Normal Saline, 3ml, IM

PLACEBO COMPARATOR

patients were given normal saline 3 ml before ERCP

Procedure: ERCP; Drug: Normal Saline

Interventions

ERCP PROCEDURE

endoscopy, retrograde cholangio-pancreaticography.

Diclofenac,75 mg, 3 ml,; Normal Saline, 3ml, IM

Diclofenac hydroxyethylpyrrolidine DRUG

Diclofenac,75 mg, 3 ml,

Normal Saline DRUG

Normal Saline, 3ml, IM

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• any patient above the age of 16, referred for ERCP

You may not qualify if:

• could not reach the ampulla due to: A. Pyloric stenosis B. Ampullary tumor C. Diverticula 2. ERCP done recently 3. Stent replacement 4. Congestive Heart Failure(CHF) 5. Asthma

Sponsors & Collaborators

• Specialized Arab Hospital: lead

Study Sites (1)

SAH hospital

Nablus, West Bank, 970, Palestinian Territories

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde; diclofenac hydroxyethylpyrrolidine; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yasser Abu-Safieh, MD, AGAF

  Specialized Arab Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof, MD, AGAF

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 20, 2013
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

PA (1)