UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026242 |
|---|---|
| Receipt number | 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 17:40:39 |
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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
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
t-ogawa@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028224
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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