Status:
COMPLETED
Photodynamic Therapy for Cholangiocarcinoma
Lead Sponsor:
Hepatopancreatobiliary Surgery Institute of Gansu Province
Conditions:
Cholangiocarcinoma Non-resectable
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.
Detailed Description
Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04860154
Start Date
April 17 2021
End Date
November 19 2024
Last Update
November 20 2024
Active Locations (11)
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1
Southwest Hospital, Army Medical University
Chongqing, Chongqing Municipality, China, 400038
2
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
3
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022