CompletedPhase 1/2

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

Egypt46 participantsStarted 2024-03-16

Plain-language summary

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. .

Who can participate

Age range19 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age more than 18 years old.
✓. Gender: males and females.
✓. Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
✓. Blood amylase and lipase levels before ERCP are within the normal limits.

Exclusion criteria

✕. Age of less than 18 years old.
✕. Uncontrolled diabetes mellitus (DM).
✕. Severe bleeding tendency.
✕. Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min).
✕. Patients with severe heart disease.
✕. Currently pregnant or nursing.
✕. Admission due to established pancreatitis before ECRP.
✕. Unwillingness to undergo ERCP.

What they're measuring

The development of pancreatitis after the procedure according to consensus criteria

Timeframe: 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

Timeframe: Biomarkers will be measured at baseline before the ERCP procedure and twenty four (24 ) hours after the procedure

Trial details

NCT IDNCT06252441

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-14

View on ClinicalTrials.gov More Post ERCP Pancreatitis trials