Photodynamic Therapy for Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Treatments: Hematoporphyrins

Criteria

Inclusion Criteria:

• ERCP cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）;

Exclusion Criteria:

• Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);

• Patients with Karnofsky Performance Scale (KPS) score≤70；

• Expected survival≤3months；

• Patients with porphyria；

• Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count(<50×10^9 / L) or using anti-coagulation drugs；

• Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage；

• Patients have intrahepatic metastasis or distant metastasis；

• Patients with no pathological diagnosis；

• known to allergic to study drug(porphyrin drugs) or other similar and related compounds；

• Other photosensitizers have been used within 4 weeks prior；

• Metal biliary stents were placed previously；

• Patients with contraindications to ERCP；

• Patients with HIV infection；

• Pregnant, parturient, or breastfeeding women；

• Patients complicated with other malignant tumors；

• Patients with severe liver function damage；

• Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT；

• Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects；

• Patients with other contraindications for photodynamic therapy.