New approach for managing jaundice before pancreatic cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates a new strategy for preoperative biliary drainage in patients with resectable pancreatic head cancer and severe obstructive jaundice. It compares the effectiveness of using serum prealbumin as a primary evaluation index against the traditional method that relies on serum total bilirubin. Through a randomized, controlled, multicenter prospective design, the study aims to assess the impact of these drainage strategies on in-hospital complications and long-term patient outcomes. The findings are expected to guide clinical decisions regarding the timing of preoperative drainage and surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Ruijin Hospital Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jun Zhang, Ph.D&M.D
• Email: zj11477@rjh.com.cn
• Phone: +86 18917530547

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.