Photodynamic Therapy for Cholangiocarcinoma

NCT ID: NCT04860154

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-17
• Study Completion Date: 2024-11-19

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 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.

Conditions

Cholangiocarcinoma Non-resectable

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PDT with 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.

Group Type: EXPERIMENTAL

Hematoporphyrin

Intervention Type: DRUG

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 bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

ERCP stent

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hematoporphyrin

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 bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.

Intervention Type: DRUG

Other Intervention Names

ERCP stents

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xun Li

Director，M.D., Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xun Li, M.D.,Ph.D.

Role: STUDY_CHAIR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

Southwest Hospital, Army Medical University

Chongqing, Chongqing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Hospital of Jilin University

Changchun, Jilin, China

General Hospital of Ningxia Medical University

Yingchuan, Ningxia, China

The first affiliated hospital of Xi 'an JiaoTong university

Xi'an, Shaanxi, China

Shandong Provincial Third Hospital

Jinan, Shandong, China

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

General Hospital of Taiyuan Iron and Steel Corporation

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Countries

China

References

Lu Y, Liu L, Wu JC, Bie LK, Gong B. Efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma: A meta-analysis. Clin Res Hepatol Gastroenterol. 2015 Dec;39(6):718-24. doi: 10.1016/j.clinre.2014.10.015. Epub 2015 Jun 10.

Reference Type: BACKGROUND

PMID: 26070572 (View on PubMed)

Gonzalez-Carmona MA, Bolch M, Jansen C, Vogt A, Sampels M, Mohr RU, van Beekum K, Mahn R, Praktiknjo M, Nattermann J, Trebicka J, Branchi V, Matthaei H, Manekeller S, Kalff JC, Strassburg CP, Weismuller TJ. Combined photodynamic therapy with systemic chemotherapy for unresectable cholangiocarcinoma. Aliment Pharmacol Ther. 2019 Feb;49(4):437-447. doi: 10.1111/apt.15050. Epub 2019 Jan 13.

Reference Type: BACKGROUND

PMID: 30637783 (View on PubMed)

Strand DS, Cosgrove ND, Patrie JT, Cox DG, Bauer TW, Adams RB, Mann JA, Sauer BG, Shami VM, Wang AY. ERCP-directed radiofrequency ablation and photodynamic therapy are associated with comparable survival in the treatment of unresectable cholangiocarcinoma. Gastrointest Endosc. 2014 Nov;80(5):794-804. doi: 10.1016/j.gie.2014.02.1030. Epub 2014 May 15.

Reference Type: BACKGROUND

PMID: 24836747 (View on PubMed)

Talreja JP, Degaetani M, Ellen K, Schmitt T, Gaidhane M, Kahaleh M. Photodynamic therapy in unresectable cholangiocarcinoma: not for the uncommitted. Clin Endosc. 2013 Jul;46(4):390-4. doi: 10.5946/ce.2013.46.4.390. Epub 2013 Jul 31.

Reference Type: BACKGROUND

PMID: 23964337 (View on PubMed)

Other Identifiers

Photodynamic therapy

Identifier Type: -

Identifier Source: org_study_id