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