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

Intramuscular 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.

Study Overview

• Status: Completed
• Conditions: Post-ERCP Acute Pancreatitis.
• Intervention / Treatment: Drug: Normal Saline; Procedure: ERCP; Drug: Diclofenac hydroxyethylpyrrolidine

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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 1

Contacts and Locations

Study Locations

• Palestinian Territories, Occupied
  • West Bank
    • Nablus, West Bank, Palestinian Territories, Occupied, 970
      • SAH hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diclofenac,75 mg, 3 ml,; patients were given Diclofenac IM before ERCP.	Procedure: ERCP; endoscopy, retrograde cholangio-pancreaticography.; Drug: Diclofenac hydroxyethylpyrrolidine
Placebo Comparator: Normal Saline, 3ml, IM; patients were given normal saline 3 ml before ERCP	Drug: Normal Saline; Procedure: ERCP; endoscopy, retrograde cholangio-pancreaticography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Specialized Arab Hospital
• Investigators: Principal Investigator: Yasser Abu-Safieh, MD, AGAF, Specialized Arab Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: diclofenac, ERCP and pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Diclofenac hydroxyethylpyrrolidine
• Other Study ID Numbers: Specialized Arab Hospital