UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047127 |
|---|---|
| Receipt number | R000053759 |
| Scientific Title | Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/10 10:02:10 |
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Basic information
Public title
Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.
Acronym
Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.
Scientific Title
Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.
Scientific Title:Acronym
Phase II study to evaluate the safety and efficacy of endoscopic radiofrequency ablation of the bile duct using the Habib Endo HPB catheter in patients with unresectable cholangiocarcinoma after biliary stent placement.
Region
| Japan |
Condition
Condition
Cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
An exploratory study of the safety and efficacy of endoscopic radiofrequency ablation of the bile ducts in patients with unresectable cholangiocarcinoma after biliary stent placement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All adverse events within 28 days after ERCP, including endoscopic RFA procedures
Key secondary outcomes
RFA procedure success rate, stent patency after RFA, and overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Perform one endoscopic radiofrequency ablation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged 20 years or older at enrollment
(2) Patients diagnosed with cholangiocarcinoma
(3) Patients requiring biliary drainage by ERCP and a plastic stent inserted at the first ERCP
(4) Patients with obstructive jaundice with a serum total bilirubin (T-Bil) of 3 or higher before first ERCP
(5) Clinical stage III or IV and not indicated for radical surgical treatment.
(6) Performance status 0-2
(7) Any gender (8) On gemcitabine-based chemotherapy
Key exclusion criteria
(1) Patients in poor general condition who cannot undergo endoscopy
(2) Patients taking more than 2 antiplatelet/anticoagulant drugs
(3) Patients with a pacemaker implanted
(4) Patients with a fever of 37.5 or higher and suspected cholangitis
(5) Other patients deemed unsuitable for the procedure by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Hasegawa |
Organization
Yokohama City University Hospital
Division name
Division of Endoscopy
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2800
t166064d@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Hasegawa |
Organization
Yokohama City University Hospital
Division name
Division of Endoscopy
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2800
Homepage URL
t166064d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional ethics committee of Yokohama city university hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
Tel
045-787-2800
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053759
