Actively Recruiting
Led by Shanghai Zhongshan Hospital · Updated on 2025-01-22
322
Participants Needed
1
Research Sites
35 weeks
Total Duration
S
Shanghai Zhongshan Hospital
Lead Sponsor
H
Huadong Hospital
Collaborating Sponsor
Researchers are studying the effects of external drainage of the main pancreatic duct and common bile duct on postoperative complications, especially pancreatic fistula, following pancreaticoduodenectomy (PD). PD is a common surgery for tumors in the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. Although mortality rates have decreased in experienced centers, complications like pancreatic fistula, delayed gastric emptying, and biliary leakage remain frequent and serious concerns. This trial aims to clarify whether external drainage reduces these complications compared to internal drainage, especially in patients at intermediate or high risk of pancreatic fistula. The study compares two surgical methods after PD: external drainage using patented silicone tubes with one-way valves for both the pancreatic and biliary ducts, and internal drainage involving sutured anastomoses with stents in the pancreatic duct and bile duct. Each method involves detailed surgical techniques to connect the pancreatic and bile ducts to the jejunum. Participants will be randomly assigned to one of these two groups to assess differences in postoperative outcomes. Participants will be followed for 90 days after surgery to monitor the occurrence of clinically relevant pancreatic fistula and other complications such as bleeding, infection, and delayed gastric emptying. Researchers will also track hospital stay length, treatment costs, reoperation and readmission rates, and long-term survival up to five years. Assessments include clinical evaluations and complication grading to understand the safety and impact of each drainage approach.
CONDITIONS
Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay averaging 2 weeks
Participants undergo pancreaticoduodenectomy surgery with either external or internal drainage of the main pancreatic and biliary ducts as part of the procedure.
Approximately 1 surgical procedure and hospital care period
Duration - Up to 90 days after surgery
Participants are monitored for surgical complications, including pancreatic fistula and other post-operative outcomes, up to 90 days after surgery.
Follow-up visits during the 90 days post-surgery as scheduled
Duration - Up to 60 months after surgery
Participants with malignant tumors are followed up for overall survival and disease-free survival for up to 60 months after surgery.
Periodic long-term follow-up visits up to 5 years
Total: 1 location
1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Wen-Quan Wang, Yao-Lin Xu, Lin-Hui Tang...
https://pubmed.ncbi.nlm.nih.gov/41189489