UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Title of the study (Brief title)	Efficacy and safety of the endoscopic radiofrequency ablation for unresectable cholangiocarcinoma: the pilot study
Region	Japan

Condition
Condition	cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of endoscopic RFA using Habib on unresectable cholangiocarcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	technical success
Key secondary outcomes	survival time time to RBO complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	unresectable cholangiocarcinoma written written informed consent
Key exclusion criteria	immpossible to endoscopic approach bad general condition pregnant
Target sample size	10

Research contact person
Name of lead principal investigator	Takahisa Ogawa
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL	022-252-1111
Email	t-ogawa@openhp.or.jp

Public contact
Name of contact person	Takahisa Ogawa
Organization	Sendai City Medical Center
Division name	Department of Gastroenterology
Address	5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL	022-252-1111
Homepage URL
Email	t-ogawa@openhp.or.jp

Sponsor
Institute	Sendai City Medical Center
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	仙台市医療センター仙台オープン病院

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 21 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2018 Year 09 Month 21 Day
Date of closure to data entry	2018 Year 09 Month 21 Day
Date trial data considered complete	2018 Year 09 Month 21 Day
Date analysis concluded	2018 Year 09 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 28 Day
Last modified on	2018 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040330