Back to resultsPhotodynamic Therapy for Cholangiocarcinoma
Primary Purpose
Cholangiocarcinoma Non-resectable
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hematoporphyrin
Sponsored by
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
Arm Type
Experimental
No Intervention
Arm Label
PDT with stent
ERCP stent
Arm 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.
After obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.
Outcomes
Primary Outcome Measures
Bile duct patency
Patency period of the stents after treatment
Median survival time
The time of the half of the patients survived after initial therapy
Secondary Outcome Measures
Overall survival
The time from initial therapy to death or the end of the study
Karnofsky Performance Scale
The Karnofsky Performance Scale scores range from 0 (death) to 100 (normal). The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is a normal activity with effort and some signs or symptoms of the disease. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
EORTCQLQ-C30 score used to assess the quality of life of cancer patients. EORTCQLQ-C30 score contains 30 questions, the first 28 questions include 1-4 points, the lower the score, the better; but the latter two questions include 1-7 points, the higher the score, the better. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
The change of weight in kilograms
Weight changes of the patient before and after PDT treatment, pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
Beck Anxiety Inventory
BAI is a 21-item self-reported questionnaire that measures the existence and severity of symptoms of anxiety. Each of the 21 items on the BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe", pre-operation, 1 month, 3 months, 6 months, 9 months and 12 months after the operation
Cumulative treatment costs
The overall treatment costs from initial PDT to death or the end of the study
Full Information
NCT ID
NCT04860154
First Posted
April 17, 2021
Last Updated
September 24, 2023
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
1. Study Identification
Unique Protocol Identification Number
NCT04860154
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma Non-resectable
Keywords
ERCP, PDT, Cholangiocarcinoma, Bile duct drainage, Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PDT with stent
Arm Type
Experimental
Arm 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.
Arm Title
ERCP stent
Arm Type
No Intervention
Arm Description
After obtaining bile duct biopsy, the candidates were placed with biliary plastic stents or metal stents directly.
Intervention Type
Drug
Intervention Name(s)
Hematoporphyrin
Other Intervention Name(s)
ERCP stents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bile duct patency
Description
Patency period of the stents after treatment
Time Frame
3years (every 3 months or obstruction appears)
Title
Median survival time
Description
The time of the half of the patients survived after initial therapy
Time Frame
3years (every 3 months）
Secondary Outcome Measure Information:
Title
Overall survival
Description
The time from initial therapy to death or the end of the study
Time Frame
5years (every 3 months）
Title
Karnofsky Performance Scale
Description
The Karnofsky Performance Scale scores range from 0 (death) to 100 (normal). The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is a normal activity with effort and some signs or symptoms of the disease. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
Time Frame
1year (baseline and every 3 months）
Title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30
Description
EORTCQLQ-C30 score used to assess the quality of life of cancer patients. EORTCQLQ-C30 score contains 30 questions, the first 28 questions include 1-4 points, the lower the score, the better; but the latter two questions include 1-7 points, the higher the score, the better. pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
Time Frame
1year (baseline and every 3 months）
Title
The change of weight in kilograms
Description
Weight changes of the patient before and after PDT treatment, pre-operation, 1 month, 3 months, 6 months, 9 months, and 12 months after the operation
Time Frame
1year (baseline and every 3 months）
Title
Beck Anxiety Inventory
Description
BAI is a 21-item self-reported questionnaire that measures the existence and severity of symptoms of anxiety. Each of the 21 items on the BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe", pre-operation, 1 month, 3 months, 6 months, 9 months and 12 months after the operation
Time Frame
1year (baseline and every 3 months）
Title
Cumulative treatment costs
Description
The overall treatment costs from initial PDT to death or the end of the study
Time Frame
5years (baseline and in each year）
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Li, M.D.,Ph.D.
Phone
+86 13993138612
Email
drlixun@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbo Meng, M.D.,Ph.D.
Phone
+86 13919177177
Email
mengwb@lzu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Li, M.D.,Ph.D.
Organizational Affiliation
Hepatopancreatobiliary Surgery Institute of Gansu Province
Official's Role
Study Chair
Facility Information:
Facility Name
Southwest Hospital, Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leida Zhang, M. D.
Phone
+86 13508320249
Email
zld666@aliyun.com
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Li, M.D.,Ph.D.
Phone
+8613993138612
Email
drlixun@163.com
First Name & Middle Initial & Last Name & Degree
Wenbo Meng, M.D.,Ph.D.
Phone
+8613919177177
Email
mengwb@lzu.edu.cn
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Xue, M. D.
Phone
+8613316118977
Email
drxueping@medmail.com.cn
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kailin Cai, M. D.
Phone
+86 13971086496
Email
caikailin@hust.edu.cn
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Wang, M. D.
Phone
+86 15804300199
Email
wmgdwk@163.com
Facility Name
General Hospital of Ningxia Medical University
City
Yingchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Wang, M. D.
Phone
+86 13895098592
Email
wq-6562@163.com
Facility Name
The first affiliated hospital of Xi 'an JiaoTong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Sun, M. D.
Phone
+86 13891813691
Email
sunhaoxjfy@126.com
Facility Name
Shandong Provincial Third Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Zhang, M. D.
Phone
+86 13805312159
Email
zhangkai.2159@163.com
Facility Name
Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefeng Wang, M. D.
Phone
+86 13601833209
Email
wxxfd@live.cn
Facility Name
General Hospital of Taiyuan Iron and Steel Corporation
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jijun Zhang, M. D.
Phone
+8613700500462
Email
zjj3210@hotmail.com
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingmei Shao, M. D.
Phone
+86 13579858830
Email
syingmei3000@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26070572
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.
Results Reference
background
PubMed Identifier
30637783
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.
Results Reference
background
PubMed Identifier
24836747
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.
Results Reference
background
PubMed Identifier
23964337
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.
Results Reference
background
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Photodynamic Therapy for Cholangiocarcinoma
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