NCT07083063 Precise Endoscopic Application of Nitroglycerin in Preventing Post-ERCP Pancreatitis
| NCT ID | NCT07083063 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 440 participants in total. It began in 2025-09-15 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically demanding procedure combining endoscopy and fluoroscopy to diagnose and treat pancreaticobiliary disorders such as bile duct stones, strictures, and cholangitis. Despite its therapeutic value, ERCP carries a relatively high complication risk of about 10%, with severe complications occurring in roughly 24% of those affected and mortality rates between 0.2% and 0.7%. The most common and significant complication is post-ERCP pancreatitis (PEP), occurring in 2% to 10% of average patients and up to 40% or higher in high-risk groups. PEP ranges from mild, self-limiting inflammation to severe, life-threatening conditions including pancreatic necrosis and multi-organ failure. PEP arises from mechanical trauma, hydrostatic injury, chemical irritation, or infection during ERCP that activates inflammatory pathways within the pancreas. Key patient-related risk factors include young age, female sex, prior pancreatitis, and sphincter of Oddi dysfunction; procedural factors include difficult biliary cannulation, pancreatic duct manipulation, and precut sphincterotomy. Preventive strategies focus on minimizing mechanical injury and pharmacologic prophylaxis. Rectal NSAIDs (indomethacin, diclofenac) administered immediately before ERCP are well-supported for reducing PEP risk. Periprocedural aggressive intravenous hydration and prophylactic pancreatic duct stenting in high-risk cases also lower PEP incidence. Nitroglycerin, a smooth muscle relaxant acting via nitric oxide-mediated sphincter relaxation, has shown promise in PEP prevention, especially in patients contraindicated for NSAIDs. Clinical trials indicate that transdermal or sublingual nitroglycerin reduces PEP rates, and combined use with NSAIDs may enhance protection. However, current guidelines do not routinely recommend nitroglycerin due to limited consensus on its efficacy. Topical nitroglycerin, known to relax smooth muscles locally and used in anorectal conditions, might reduce sphincter of Oddi pressure without systemic side effects. This suggests potential benefit in lowering PEP incidence or severity when applied topically during ERCP, pending further investigation. This study aimed to investigate whether topical delivery of nitroglycerin can reduce the incidence rate of PEP or the severity of pancreatitis.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07083063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07083063 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07083063 currently recruiting?
Yes, NCT07083063 is actively recruiting participants. Contact the research team at scion456scion@gmail.com for enrollment information.
Where is the NCT07083063 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT07083063 clinical trial?
NCT07083063 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 440 participants.