Actively Recruiting
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-02-13
300
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
N
Ningbo No. 1 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pancreatic cancer is a serious and often deadly disease, with pancreaticoduodenectomy being the standard treatment for tumors in the pancreatic head and nearby areas. However, this surgery carries a high risk of complications, especially postoperative pancreatic fistula, which can affect 25% to 50% of patients. Researchers are studying whether using external versus internal pancreatic duct stents can lower the risk of these complications, focusing on patients with different levels of risk as determined by the Updated Alternative Fistula Risk Score (ua-FRS). The study compares two types of pancreatic duct stents during pancreaticoduodenectomy: an external stent, which exits through the abdominal wall, and an internal stent, a silicone catheter placed inside the pancreatic duct and jejunum. All surgeries are performed by the same specialized team using laparoscopic or open approaches, with reconstruction using the child's technique. Patients are assigned randomly to receive either the external or internal stent to evaluate the effect on postoperative outcomes. Participants will be monitored for at least one month after surgery to track the occurrence of clinically relevant postoperative pancreatic fistula (CR-POPF) and other complications. Assessments include clinical evaluations and follow-up to measure the primary outcome of CR-POPF incidence. The study aims to clarify the safety and effectiveness of external stents in both high-risk and low-risk patients undergoing pancreaticoduodenectomy, with all procedures and outcomes carefully recorded by the research team.
CONDITIONS
Brief Title
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis performed
- No combined organic diseases in the heart, lungs, or kidneys
- No history of chemotherapy, radiotherapy, upper abdominal surgery, or other tumors
- A pancreatic fistula risk score (ua-FRS) higher than 5%
You will not qualify if you...
- Previous history of other tumors or upper abdominal surgery
- Multiple lesions and distant metastasis
- Organic diseases of important organs such as heart, lung, and kidney that prevent surgery
- Age less than 18 years or greater than 75 years
- Use of other methods to prevent pancreatic fistula, such as fibrin glue sealing, that may affect study accuracy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay of variable length after surgery
Participants undergo pancreaticoduodenectomy with either an external or internal pancreatic duct stent placed during surgery to help prevent postoperative pancreatic fistula. Immediate post-operative care is provided after the procedure.
1 surgical procedure with in-hospital care
Duration - Up to 1 month after surgery
Participants are monitored for clinically relevant postoperative pancreatic fistula and other complications following surgery.
Approximately 1 to 2 follow-up visits within 1 month
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
Actively Recruiting
Research Team
S
Sheng Yan, Doctor
G
Guogang Li, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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