Precise endoscopic nitroglycerin to prevent pancreatitis after ERCP
Official title: Precise Endoscopic Application of Nitroglycerin in Preventing Post-ERCP Pancreatitis: A Randomized Controlled Trial
Run by National Cheng-Kung University Hospital · NCT07083063 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Other (Non U.s.)) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07083063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.