UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026242
Receipt No. R000028224
Scientific Title Cholangioscopy- versus fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a prospective crossover study
Date of disclosure of the study information 2017/02/21
Last modified on 2019/03/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Cholangioscopy- versus fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a prospective crossover study
Acronym Cholangioscopy- versus fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a a prospective crossover study
Scientific Title Cholangioscopy- versus fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a prospective crossover study
Scientific Title:Acronym Cholangioscopy- versus fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma: a a prospective crossover study
Region
Japan

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

Objectives
Narrative objectives1 to compare cholangiosopy-guided technique with fluoroscopy-guided technique of transpapillary mapping biopsy for preoperative evaluation of extrahepatic cholangiocarcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the success rate of mapping biopsy
Key secondary outcomes the rate of specimens insufficient for histological examination

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Transpapillary mapping biopsy under fluoroscopic guidance.
Interventions/Control_2 Transpapillary mapping biopsy under cholangioscopic guidance.
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 suspected extrahepatic cholangiocarcinoma based on the finding of multi-detector row computed tomography; possibly resectable lesion; obtaining written informed consent about participating study
Key exclusion criteria impossible transpapirally approach;poor general condition (performance status 3 or 4); definite inoperable factors such as distal metastases and peritoneal dissemination detected by MDCT; refusal of surgical treatment; age under 18 years old; pregnancy
Target sample size 28

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

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Ogawa
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code 983-0824
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)

IRB Contact (For public release)
Organization the institutional review board of Sendai City Medical Center
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
Tel 022-252-1111
Email k.tochikubo@openhp.or.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 仙台市医療センター仙台オープン病院(宮城県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 21 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 Completed
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
2016 Year 08 Month 26 Day
Anticipated trial start date
2016 Year 08 Month 26 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 03 Month 05 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.