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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Feb 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of two types of stents—external and internal—after a specific type of surgery called pancreaticoduodenectomy, which is often performed to treat pancreatic conditions. The goal is to see which type of stent is better at preventing a complication known as a pancreatic fistula, which is when the pancreas leaks digestive fluids into the abdomen. Researchers will look at both high-risk and low-risk patients to understand how these stents affect the chances of developing this complication.

To participate in the trial, patients must have undergone the pancreaticoduodenectomy surgery and have a specific risk score indicating they are at a higher risk for developing a pancreatic fistula. Eligible participants should be between 18 and 75 years old and must not have serious health issues affecting their heart, lungs, or kidneys, nor a history of certain cancers or previous major abdominal surgeries. If you join this study, you will help researchers learn more about the best ways to prevent complications after surgery, which could improve outcomes for future patients.

Gender

ALL

Eligibility 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.