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

NCT ID: NCT01946984

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

Brief Summary

1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.

2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.

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. 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.

Detailed Description

• All patients signed informed consents for the procedure, and the participation in the study.
• Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
• Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
• A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
• Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:

1. the total time of the procedure,

2. the number of attempts at cannulation,

3. the number of pancreatic duct cannulation,

4. the final diagnosis by ERCP,

5. whether a sphincterotomy, a needle-knife papillotomy, or stent placement were performed.

• Serum amylase was determined 12 hours after ERCP.

• If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
• Acute pancreatitis was defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
• Statistical analysis:

1. Randomization was done by the GI nurse, concealed envelop

2. Data were summarized by descriptive statistics.

3. The Chi square was used to compare categorical patient data.

4. The Student's t test was used to compare continuous variables.

5. Two-tailed P < 0.05 was considered to indicate significance.

Conditions

Post-ERCP Acute Pancreatitis.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Diclofenac,75 mg, 3 ml,

patients were given Diclofenac IM before ERCP.

Group Type: ACTIVE_COMPARATOR

ERCP

Intervention Type: PROCEDURE

endoscopy, retrograde cholangio-pancreaticography.

Diclofenac hydroxyethylpyrrolidine

Intervention Type: DRUG

Normal Saline, 3ml, IM

patients were given normal saline 3 ml before ERCP

Group Type: PLACEBO_COMPARATOR

ERCP

Intervention Type: PROCEDURE

endoscopy, retrograde cholangio-pancreaticography.

Normal Saline

Intervention Type: DRUG

Interventions

ERCP

endoscopy, retrograde cholangio-pancreaticography.

Intervention Type: PROCEDURE

Diclofenac hydroxyethylpyrrolidine

Intervention Type: DRUG

Normal Saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 1.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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Specialized Arab Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasser Abu-Safieh

Associate Prof, MD, AGAF

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasser Abu-Safieh, MD, AGAF

Role: PRINCIPAL_INVESTIGATOR

Specialized Arab Hospital

Locations

SAH hospital

Nablus, West Bank, Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

Specialized Arab Hospital

Identifier Type: -

Identifier Source: org_study_id