Photodynamic Therapy for Cholangiocarcinoma
Cholangiocarcinoma Non-resectable
About this trial
This is an interventional treatment trial for Cholangiocarcinoma Non-resectable focused on measuring ERCP, PDT, Cholangiocarcinoma, Bile duct drainage, Stent
Eligibility 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.
Sites / Locations
- Southwest Hospital, Army Medical UniversityRecruiting
- The First Hospital of Lanzhou UniversityRecruiting
- The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- The First Hospital of Jilin University
- General Hospital of Ningxia Medical UniversityRecruiting
- The first affiliated hospital of Xi 'an JiaoTong university
- Shandong Provincial Third HospitalRecruiting
- Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
- General Hospital of Taiyuan Iron and Steel CorporationRecruiting
- The First Affiliated Hospital of Xinjiang Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
PDT with stent
ERCP stent
Before photodynamic therapy, candidate patients undergoing biliary biopsy and biliary duct drainage. If pathology shows a bile duct malignancy, PDT therapy will carry out until total bilirubin drops below 100 μmol/L.Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or metal stent will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.
After obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.