About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- External pancreatic duct stent
- Internal pancreatic duct stent
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Ningbo No. 1 Hospital
Collaborator
Huizhou Municipal Central Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Third Affiliated Hospital of Wenzhou Medical University
Collaborator
Linping First People's Hospital
Collaborator