Comparing oral N-acetyl cysteine and rectal diclofenac for preventing pancreatitis after ERCP

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

This study tests whether taking oral N-acetyl cysteine or using rectal diclofenac can help prevent pancreatitis in adults having an ERCP procedure.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: Tanta University (Academic / other)
• Locations: 1 site (Menofia)
• Trial ID: NCT06252441 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of two interventions, oral N-acetyl cysteine (NAC) and rectal diclofenac, in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, a common complication following the procedure. Participants will be adults over 18 years old who are scheduled for ERCP due to suspected pancreato-biliary disorders and have normal pancreatic enzyme levels prior to the procedure. The study will assess the incidence of pancreatitis based on established diagnostic criteria and the severity of any complications that arise. By comparing these two treatment approaches, the study seeks to identify a more effective preventive strategy for this serious condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with indications for ERCP and normal pancreatic enzyme levels.

Not a fit: Patients with uncontrolled diabetes, severe heart disease, or those who have had prior biliary or pancreatic interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method for preventing pancreatitis after ERCP, potentially reducing patient morbidity and healthcare costs.

How similar studies have performed: While there have been studies on preventing post-ERCP pancreatitis, the specific comparison of oral NAC and rectal diclofenac is a novel approach.

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).

Where this trial is running

Menofia

• Obstructive Jaundice Clinic in the National Liver Institute, Menoufia University , Shebin Elkoom — Menofia, Egypt (Recruiting)

Study contacts

• Study coordinator: Mariam Tabana

Conditions Post ERCP Pancreatitis