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Topical Nitroglycerin for Preventing Post-ERCP Pancreatitis
NCT07083063Phase 4
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- National Cheng Kung University Hospital
- Modality
- Small Molecules
- Drugs
- nitroglycerin
- Conditions
- post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP)
01
Overview
Phase 4, randomised trial of nitroglycerin in post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) (2 arms), sponsored by National Cheng Kung University Hospital. Primary endpoint: Occurrence of Post-ERCP pancreatitis at 7 days. Started Sep 2025; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Intervention Group
Topical delivery of diluted 1mg nitroglycerin in normal saline (1mg/10cc) to the major papilla during ERCP, alongside standard care.
Standard Group
Topical delivery of 10cc normal saline to the major papilla during ERCP, alongside standard care.
03
Who it enrols
Adult patients with choledocholithiasis undergoing ERCP and sphincterotomy for common bile duct stone extraction, excluding those with pancreatic cancer, shock status, allergy to NTG, angle-closure glaucoma, severe anemia, or on PDE 5 inhibitors.
04
Endpoints
Primary
Occurrence of Post-ERCP pancreatitis
Secondary
Occurrence of moderate or severe Post-ERCP pancreatitis
Occurrence of post-ERCP bleeding
Occurrence of shock status
Length of hospitalization
Level of pancreatic serology
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