Photodynamic Therapy for Cholangiocarcinoma

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status: Completed

Conditions: Cholangiocarcinoma Non-resectable

Treatments: Drug: Hematoporphyrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04860154

Photodynamic therapy

Details and patient eligibility

About

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

Full 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 in the early stage. After late diagnosis, the effective treatment is surgical resection and & or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention.

This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

PDT with stent

Experimental group

Description:

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.

Treatment:

Drug: Hematoporphyrin

ERCP stent

No Intervention group

Description:

After obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.