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

NCT06252441 | Completed Phase 1

• 1 other identifier: Post ERCP Pancreatitis
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Post ERCP Pancreatitis

Outcome Measures

Primary Outcomes (2)

• The development of pancreatitis after the procedure according to consensus criteria

  Briefly in this criteria PEP will be diagnosed if the patient met two of the three following criteria after ERCP: A- New onset or increased abdominal pain consistent with acute pancreatitis B- Pancreatic enzyme elevation to at least three times the upper limit of normal at twenty four (24) hours after the procedure C- Necessity for new or continued hospitalization for at least two nights

  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

  These markers measure the degree of systemic inflammation as predictors of the development of PEP.

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

Study Arms (2)

Rectal Diclofenac

ACTIVE COMPARATOR

This Group will include 23 patients who will receive 100 mg rectal diclofenac before ERCP.

Drug: Rectal Diclofenac

Oral N-acetyl cysteine

ACTIVE COMPARATOR

This Group will include 23 patients who will receive 1200 mg N-acetyl cysteine in 150 cc water orally before ERCP.

Drug: Oral N-acetyl cysteine

Interventions

Rectal Diclofenac DRUG

100 mg Rectal Diclofenac Before ERCP

Rectal Diclofenac

Oral N-acetyl cysteine DRUG

1200 mg N-acetyl cysteine in 150 cc water orally before ERCP.

Oral N-acetyl cysteine

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previously documented allergy to NAC or diclofenac or any other NSAIDs.
• History of NSAIDs intake one week before the procedure.
• Recent Active bleeding, ulcer, or asthma.
• Patients with rectal disease (hemorrhoids, fissures, abscesses, and incontinence).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Obstructive Jaundice Clinic in the National Liver Institute, Menoufia University , Shebin Elkoom

Menofia, Egypt

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant , Faculty of Pharmacy, Menoufia University

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: March 16, 2024
• Primary Completion: May 14, 2025
• Study Completion: June 25, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)