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Clinical trial

Comparative Clinical Study to Evaluate the Possible Efficacy and Safety of Oral N-Acetyl Cysteine Versus Rectal Diclofenac in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis

ID
Name
Post ERCP Pancreatitis
Description
The aim of the current study is to compare the efficacy and safety of oral NAC and rectal diclofenac in preventing Post Endoscopic retrograde cholangiopancreatography Pancreatitis. .
Trial arms
Trial start
2024-02-01
Estimated PCD
2025-04-01
Trial end
2025-05-01
Status
Recruiting
Phase
Early phase I
Treatment
Rectal Diclofenac
100 mg Rectal Diclofenac Before ERCP
Arms:
Rectal Diclofenac
Oral N-acetyl cysteine
1200 mg N-acetyl cysteine in 150 cc water orally before ERCP.
Arms:
Oral N-acetyl cysteine
Size
46
Primary endpoint
The development of pancreatitis after the procedure according to consensus criteria
Before performing ERCP, baseline serum amylase and lipase levels will be measured in all patients. After twenty four ( 24) hours post ERCP procedure, patients' serum amylase and lipase levels will be measured.
The change in the serum levels of Tumor necrosis factor alpha (TNF-α) and Interleukin-10 (IL-10 )before and after ERCP procedure
Biomarkers will be measured at baseline before the ERCP procedure and twenty four (24 ) hours after the procedure
Eligibility criteria
Inclusion Criteria: 1. Age more than 18 years old. 2. Gender: males and females. 3. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders. 4. Blood amylase and lipase levels before ERCP are within the normal limits. Exclusion Criteria: 1. Age of less than 18 years old. 2. Uncontrolled diabetes mellitus (DM). 3. Severe bleeding tendency. 4. Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min). 5. Patients with severe heart disease. 6. Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct. 7. Currently pregnant or nursing. 8. Admission due to established pancreatitis before ECRP. 9. Unwillingness to undergo ERCP. 10. Previously documented allergy to NAC or diclofenac or any other NSAIDs. 11. History of NSAIDs intake one week before the procedure. 12. Recent Active bleeding, ulcer, or asthma. 13. Patients with rectal disease (hemorrhoids, fissures, abscesses, and incontinence).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}
Updated at
2024-02-09

1 organization

2 products

1 indication

Organization
Tanta University
Product
Rectal Diclofenac
Indication
Post-ERCP Pancreatitis
Product
N-acetyl cysteine