Precise endoscopic nitroglycerin to prevent pancreatitis after ERCP
Precise Endoscopic Application of Nitroglycerin in Preventing Post-ERCP Pancreatitis: A Randomized Controlled Trial
This trial will try applying a small amount of nitroglycerin during ERCP to see if it lowers the chance of post-ERCP pancreatitis in adults having ERCP with sphincterotomy for bile duct stones.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Other (Non U.s.)) |
| Trial ID | NCT07083063 on ClinicalTrials.gov |
What this trial studies
Adults undergoing ERCP with sphincterotomy for common bile duct stone removal will receive a targeted endoscopic application of nitroglycerin or a normal saline control during the procedure, and outcomes will track rates of post-ERCP pancreatitis and related complications. The protocol is interventional (Phase 4) and enrolls patients aged 18 and older who consent to ERCP and sphincterotomy, excluding those with pancreatic cancer, shock, nitroglycerin allergy, angle-closure glaucoma, severe anemia, or current PDE5 inhibitor use. Procedural exposure is brief and delivered at the time of ERCP, with follow-up to capture clinical pancreatitis, severity, and any adverse events. The trial is conducted at National Cheng Kung University Hospital in Tainan, Taiwan.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) scheduled for ERCP with sphincterotomy to remove common bile duct stones who do not have the listed exclusion conditions.
Not a fit: Patients with contraindications to nitroglycerin (for example on PDE5 inhibitors, with severe anemia, angle-closure glaucoma, or hemodynamic shock) would not be expected to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of post-ERCP pancreatitis and its associated hospitalization and complications.
How similar studies have performed: Previous trials of nitrates for PEP prevention have shown mixed results, with some studies and meta-analyses suggesting a modest benefit while others found no clear effect.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible participants include patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction. Exclusion Criteria: * patients with pancreatic cancer * shock status (systolic blood pressure \< 90 mmHg or using inotropic agents) * allergy to NTG * angle-closure glaucoma * severe anemia * patients on PDE 5 inhibitors
Where this trial is running
Tainan, Other (Non U.s.)
- National Cheng Kung University Hospital — Tainan, Other (Non U.s.), Taiwan (Recruiting)
Study contacts
- Study coordinator: Hsueh-Chien Chiang, MD
- Email: scion456scion@gmail.com
- Phone: +88662353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.