Clinical trial NCT04860154: Photodynamic Therapy for Cholangiocarcinoma
Official title: Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma：a Prospective Non-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma Non-resectable
Keywords: ERCP
PDT
Cholangiocarcinoma
Bile duct drainage
Stent
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Bile duct patency
timeFrame: 3years (every 3 months or obstruction appears)
measure: Median survival time
timeFrame: 3years (every 3 months）
Secondary outcomes:
measure: Overall survival
timeFrame: 5years (every 3 months）
measure: Karnofsky Performance Scale
timeFrame: 1year (baseline and every 3 months）
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
timeFrame: 1year (baseline and every 3 months）
measure: The change of weight in kilograms
timeFrame: 1year (baseline and every 3 months）
measure: Beck Anxiety Inventory
timeFrame: 1year (baseline and every 3 months）
measure: Cumulative treatment costs
timeFrame: 5years (baseline and in each year）
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital, Army Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yingchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The first affiliated hospital of Xi 'an JiaoTong university
state: Shaanxi
city: Jinan
country: China
facility: Shandong Provincial Third Hospital
state: Shandong
city: Shanghai
country: China
facility: Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: General Hospital of Taiyuan Iron and Steel Corporation
state: Shanxi
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D.,Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.