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

Post-ERCP Acute Pancreatitis. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946984
• Other study ID #: Specialized Arab Hospital
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2013
• Last updated: September 19, 2013
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Specialized Arab Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis.

Intervention

Procedure:
• ERCP
endoscopy, retrograde cholangio-pancreaticography.

Drug:
• Diclofenac hydroxyethylpyrrolidine

• Normal Saline

Locations

Country	Name	City	State
Palestinian Territories, Occupie	SAH hospital	Nablus	West Bank

Sponsors (1)

Lead Sponsor	Collaborator
Specialized Arab Hospital

Country where clinical trial is conducted

Palestinian Territories, Occupie, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of pancreatitis,	Patients with epigastric pain, back pain, and epigastric tenderness,; 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	Yes