New approach for managing jaundice before pancreatic cancer surgery
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice, a Multicenter, Open-label, Randomized Controlled Clinical Study
NA · Ruijin Hospital · NCT06541340
This study is testing a new way to manage jaundice in patients with pancreatic cancer before surgery to see if using a different blood test can lead to better outcomes and fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06541340 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of resectable pancreatic head cancer and severe obstructive jaundice.
Not a fit: Patients with other malignant tumors, uncontrolled medical conditions, or those who cannot tolerate surgery or biliary drainage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications for patients with pancreatic head cancer and obstructive jaundice.
How similar studies have performed: While the effectiveness of preoperative biliary drainage strategies is debated, this specific approach using serum prealbumin is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer, Obstructive Jaundice, pancreatic head cancer, obstructive Jaundice, preoperative biliary drainage, prealbumin