Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

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

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment440 (estimated)
SponsorNational Cheng-Kung University Hospital
Academic / other
Locations1 site (Tainan, Other (Non U.s.))
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedJuly 31, 2027
Study endsJuly 31, 2027
Registry record updatedDecember 8, 2025
Trial IDNCT07083063 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.