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

• 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:

• the total time of the procedure,
• the number of attempts at cannulation,
• the number of pancreatic duct cannulation,
• the final diagnosis by ERCP,
• 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:

• Randomization was done by the GI nurse, concealed envelop
• Data were summarized by descriptive statistics.
• The Chi square was used to compare categorical patient data.
• The Student's t test was used to compare continuous variables.
• Two-tailed P < 0.05 was considered to indicate significance.

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