A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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

300 Participants
are divided into 2 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