A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified strategy, Traditional strategy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Obstructive Jaundice. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study
Overview
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.
Interventions
- Procedure Modified strategy
Modified preoperative biliary drainage strategy with prealbumin as the main indicator - Procedure Traditional strategy
Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator
Primary outcome measures
- In-hospital complications [Time frame: During hospitalization, up tp 3 months]
Secondary outcome measures (3)
- Recurrence/metastasis [Time frame: 12 months after discharge]
- Mortality [Time frame: 12 months after discharge]
- Long-term complications [Time frame: 12 months after discharge]
Eligibility criteria
Inclusion criteria
- 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
- Preoperative imaging stage is resectable
- Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
- Age >18 and ≤75 years old
- ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
- Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation
Exclusion criteria
- Combined with other malignant tumors
- Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
- Pregnant and lactating women
- Patients who cannot tolerate preoperative biliary drainage or radical surgery
- Other situations that are not suitable for inclusion in clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT06541340 · PROB