A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice
NCT Number: NCT06541340
Acronym: PROB
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer|Obstructive Jaundice
Interventions: PROCEDURE: Modified strategy|PROCEDURE: Traditional strategy
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-12-31
Locations: Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 200025, China

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.

Primary Outcome Measures: In-hospital complications, 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., During hospitalization, up tp 3 months
Secondary Outcome Measures: Recurrence/metastasis, 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., 12 months after discharge|Mortality, 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., 12 months after discharge|Long-term complications, 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., 12 months after discharge