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

Launched by RUIJIN HOSPITAL · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to managing severe jaundice caused by pancreatic head cancer before surgery. Jaundice is a condition where the skin and eyes turn yellow due to a buildup of a substance called bilirubin, often caused by a blockage in the bile duct from the tumor. The study aims to compare two strategies for draining bile: one that uses a specific blood test (serum prealbumin) to guide treatment and another that relies on a different test (serum total bilirubin). Researchers want to see which method leads to fewer complications during and after hospital stays, as well as better long-term health outcomes for patients who are eligible for surgery to remove the cancer.

To participate in this trial, individuals need to be between 18 and 75 years old and diagnosed with resectable pancreatic head cancer, which means it can be surgically removed. They should also have significant jaundice and not have received any previous bile drainage treatment. Participants will receive standard care, including a procedure to drain bile before surgery, and will help advance medical knowledge about the best ways to manage their condition. If you or someone you know is facing this situation, consider discussing participation in this trial with a healthcare provider for more information.

Gender

ALL

Eligibility 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