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

What this Trial Is About

Researchers are evaluating new strategies for preoperative biliary drainage in patients with resectable pancreatic head cancer who have severe obstructive jaundice. This trial compares a modified drainage approach using serum prealbumin levels as the main evaluation marker against the traditional approach relying on serum total bilirubin levels. The study aims to determine the impact of these strategies on in-hospital complications and long-term outcomes, providing evidence to guide clinical decisions on drainage timing and surgery scheduling. Participants will be randomly assigned to one of two groups: one receiving the traditional preoperative biliary drainage strategy based on total bilirubin, and the other receiving the modified strategy based on prealbumin levels. Both groups will undergo endoscopic biliary drainage (ERCP) prior to radical pancreaticoduodenectomy surgery. The study is multicenter, open-label, and controlled, with treatment and evaluation occurring before surgery. During the study, patients will be monitored for complications during hospitalization up to three months after treatment. Researchers will also track recurrence or metastasis, mortality, and long-term complications up to 12 months after discharge. Assessments include clinical evaluations and laboratory measurements to monitor drainage effectiveness and patient safety. The total duration of participation includes preoperative evaluation, treatment, and follow-up over one year to assess outcomes comprehensively.

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