Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis
Condition: Post-ERCP Acute Pancreatitis.
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): ERCP; Diclofenac hydroxyethylpyrrolidine; Normal Saline
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): endoscopy, retrograde cholangio-pancreaticography.
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: diclofenac, ERCP and pancreatitis