RecruitingNot ApplicableNCT06541340

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


Sponsor

Ruijin Hospital

Enrollment

360 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different approaches to draining bile (called biliary drainage) before surgery in people with pancreatic head cancer that is blocking the bile duct and causing severe jaundice (yellowing of the skin and eyes). The goal is to find the best method to safely lower bilirubin levels before the major surgery (Whipple procedure) takes place. **You may be eligible if...** - You have pancreatic head cancer (confirmed by pathology or multidisciplinary clinical diagnosis) causing severe obstructive jaundice - Your tumor appears resectable (removable by surgery) on imaging - Your bilirubin level is 250 µmol/L or higher and you have not had prior biliary drainage - You are 18–75 years old and reasonably functional (ECOG ≤ 2) **You may NOT be eligible if...** - You have another active cancer - Your cancer is not resectable - You have already had biliary drainage - Your organ function does not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06541340


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