Status:

RECRUITING

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

Lead Sponsor:

Ruijin Hospital

Conditions:

Pancreatic Cancer

Obstructive Jaundice

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief 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 s...

Eligibility Criteria

Inclusion

  • 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
  • Preoperative imaging stage is resectable
  • Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
  • Age \>18 and ≤75 years old
  • ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
  • Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation

Exclusion

  • Combined with other malignant tumors
  • Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
  • Pregnant and lactating women
  • Patients who cannot tolerate preoperative biliary drainage or radical surgery
  • Other situations that are not suitable for inclusion in clinical trials

Key Trial Info

Start Date :

August 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

360 Patients enrolled

Trial Details

Trial ID

NCT06541340

Start Date

August 1 2024

End Date

December 31 2026

Last Update

August 7 2024

Active Locations (1)

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1

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200025