NCT06541340

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

A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Obstructive Jaundice

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-07
• Last updated: 2024-08-07

Locations

1 site across 1 country: China