A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Recruiting now · Not applicable
Conditions studied: Pancreatic Fistula
In brief
The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.
Key facts
- Study ID
- NCT05725590
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 300
- Starts
- 2023-02-02
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2023-02-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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