Comparing external and internal pancreatic duct stents after surgery for pancreatic cancer
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
This study is testing whether using external or internal stents after pancreatic cancer surgery can help prevent complications like pancreatic fistulas in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05725590 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of external versus internal pancreatic duct stents in preventing postoperative pancreatic fistulas in patients who have undergone pancreaticoduodenectomy. It aims to clarify the controversial benefits of these stents by using the Updated Alternative Fistula Risk Score to assess both high-risk and low-risk patients. The study will involve multiple centers and will focus on the incidence of clinically relevant postoperative complications following the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone pancreatoduodenectomy with a pancreaticojejunal anastomosis and have a risk score for pancreatic fistula greater than 5%.
Not a fit: Patients with significant comorbidities, previous abdominal surgeries, or those under 18 or over 75 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing pancreaticoduodenectomy.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of external pancreatic duct stents, indicating that while some suggest benefits, the evidence remains inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed;
* The patient has no combined organic diseases in the heart, lungs, or kidneys;
* No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study.
Exclusion Criteria:
* Previous history of other tumors or upper abdominal surgery; ② Multiple lesions and distant metastasis;
* Patients with organic diseases of important organs such as the heart, lung, and kidney, who cannot tolerate surgery, or patients who are more than 75 years old or less than 18 years old; ④ Other measures were performed to prevent pancreatic fistula, such as fibrin glue sealing, which may affect the accuracy of this study.
Where this trial is running
Hangzhou
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, China (Recruiting)
Study contacts
- Principal investigator: Yuancong Jiang, Doctor — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: Sheng Yan, Doctor
- Email: shengyan@zju.edu.cn
- Phone: 13957161680
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.