Actively Recruiting
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
Led by Ruijin Hospital · Updated on 2024-08-07
360
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.
CONDITIONS
Official Title
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological or clinical diagnosis of pancreatic head cancer with obstructive jaundice
- Planned for radical pancreaticoduodenectomy surgery
- Preoperative imaging shows resectable stage
- Baseline serum total bilirubin ≥ 250 µmol/L with no prior biliary drainage
- Age between 18 and 75 years
- ECOG physical score of 2 or less
- Signed informed consent and planned preoperative endoscopic biliary drainage and surgery timing evaluation
You will not qualify if you...
- Presence of other malignant tumors
- Uncontrolled medical diseases or organ dysfunction preventing surgery
- Pregnant or breastfeeding women
- Unable to tolerate preoperative biliary drainage or surgery
- Any other condition deemed unsuitable for clinical trial participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jun Zhang, Ph.D&M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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