A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice (PROB)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Obstructive Jaundice; Pancreatic Cancer

Treatments: Procedure: Traditional strategy; Procedure: Modified strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06541340

PROB

Details and patient eligibility

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Traditional strategy

Active Comparator group

Description:

Traditional preoperative biliary drainage strategy with total bilirubin as the main indicator

Treatment:

Procedure: Traditional strategy

Modified strategy

Experimental group

Description:

Modified preoperative biliary drainage strategy with prealbumin as the main indicator

Treatment:

Procedure: Modified strategy