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Trial Title:
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
NCT ID:
NCT06541340
Condition:
Pancreatic Cancer
Obstructive Jaundice
Conditions: Official terms:
Head and Neck Neoplasms
Jaundice
Jaundice, Obstructive
Conditions: Keywords:
pancreatic head cancer
obstructive Jaundice
preoperative biliary drainage
prealbumin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Modified strategy
Description:
Modified preoperative biliary drainage strategy with prealbumin as the main indicator
Arm group label:
Modified strategy
Intervention type:
Procedure
Intervention name:
Traditional strategy
Description:
Traditional preoperative biliary drainage strategy with total bilirubin as the main
indicator
Arm group label:
Traditional strategy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of
pancreatic head cancer after multidisciplinary discussion, clear presence of
obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical
pancreaticoduodenectomy
2. Preoperative imaging stage is resectable
3. Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary
drainage
4. Age >18 and ≤75 years old
5. ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
6. Signed informed consent, received preoperative endoscopic biliary drainage (ERCP)
and radical surgery timing evaluation
Exclusion Criteria:
1. Combined with other malignant tumors
2. Combined with uncontrolled medical diseases or organ dysfunction and other absolute
counterindications for surgery
3. Pregnant and lactating women
4. Patients who cannot tolerate preoperative biliary drainage or radical surgery
5. Other situations that are not suitable for inclusion in clinical trials
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Baiyong Shen, Ph.D&M.D
Phone:
0086-021-64370045
Investigator:
Last name:
Baiyong Shen, Ph.D&M.D
Email:
Principal Investigator
Start date:
August 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541340
