Obstructive Jaundice, Pancreatic Cancer
Conditions
Keywords
pancreatic head cancer, obstructive Jaundice, preoperative biliary drainage, prealbumin
Brief 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.
Interventions
PROCEDUREModified strategy
Modified preoperative biliary drainage strategy with prealbumin as the main indicator
PROCEDURETraditional strategy
Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital complications | During hospitalization, up tp 3 months | In-hospital complications are comprehensively evaluated by the chief surgeon, responsible doctor and their team based on clinical manifestations, laboratory tests, etc., and reviewed by the expert committee of this study. The name of the complication, time of occurrence, treatment measures and outcome are strictly recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence/metastasis | 12 months after discharge | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. |
| Mortality | 12 months after discharge | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. |
| Long-term complications | 12 months after discharge | It is mainly based on follow-up. If the follow-up was completed in our hospital, the hospital system will be directly retrieved to obtain the diagnosis information. The follow-up was conducted by interviewing the patient or his family members through telephone questionnaires or face-to-face visits to collect required information.The follow-up subjects provide medical records, etc., and record in detail the time of diagnosis of long-term complications or recurrence and metastasis, diagnostic basis, laboratory tests, treatment measures and outcomes, which must be reviewed by the expert committee of this study. |
Countries
China
Contacts
Primary ContactJun Zhang, Ph.D&M.D
Outcome results
None listed