UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041530 |
|---|---|
| Receipt number | R000047248 |
| Scientific Title | Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study |
| Date of disclosure of the study information | 2020/08/25 |
| Last modified on | 2026/02/27 10:40:57 |
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Basic information
Public title
Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study
Acronym
Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study
Scientific Title
Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility study
Scientific Title:Acronym
Optimal number of strokes for cholangioscopy-guided mapping biopsy using SpyBite Max for preoperative evaluation of lateral spread of extrahepatic cholangiocarcinoma: a prospective feasibility 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 evaluate the outcomes of cholangioscopy-guided mapping biopsy using SpyBite Max prospectively and to reveal the optimal number of strokes from the same site.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of site-based successful biopsy
Key secondary outcomes
Success rate of approaching the target sites
The rate of specimen-based successful biopsy
Diagnostic accuracy of lateral spread based on the cholangioscopic finding and cholangioscopy-guided mapping biopsy
Adverse events
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
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Cholangioscopy-guided mapping biopsy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suspected extrahepatic cholangiocarcinoma based on the findings from MDCT.
Being resectable from MDCT findings.
Written informed consent about participating in the study.
Key exclusion criteria
Impossible transpapillary approach using a duodenoscope.
Poor general condition (the Eastern Cooperative Oncology Group performance status 3 or 4).
Definite inoperable factors, such as distal metastases and peritoneal dissemination detected.
Refusal of surgical treatment.
Pregnancy.
Target sample size
20
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
81-22-252-1111
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, Japan
TEL
81-22-252-1111
Homepage URL
t-ogawa@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center,
Department of Gastroenterology
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
IRB of Sendai City Medical Center
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Japan
Tel
81-22-252-1111
scmc@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40771700/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40771700/
Number of participants that the trial has enrolled
21
Results
The cholangioscope could be advanced to all 80 target sites. The overall adequate specimen rate was 67% (142/212). The overall rate of site-based successful biopsies was 83% (66/80). The cumulative success rate of obtaining appropriate materials did not significantly improve by increasing the number of biopsy strokes from 1 (81%) to 4 (86%).
Results date posted
| 2026 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 06 | Day |
Baseline Characteristics
Patients who met the following inclusion criteria and did not
meet any exclusion criteria were consecutively enrolled in this
study. Inclusion criteria included: (1) suspected extrahepatic
cholangiocarcinoma based on multidetector-row
computed tomography
(MDCT), magnetic resonance imaging (MRI), or
endoscopic ultrasonography (EUS) findings, (2) resectability
as determined by MDCT findings, and (3) provision of written
informed consent for study participation. The exclusion criteria
included: (1) inability to perform a transpapillary approach
with a duodenoscope, (2) poor general condition (the Eastern
Cooperative Oncology Group performance status 3 or 4) [13],
(3) definite inoperable factors, such as distal metastases and detected
peritoneal dissemination, (4) refusal of surgery, (5) bleeding
tendency, and (6) pregnancy. The patients who underwent
biliary drainage before mapping biopsy were not excluded from
this study.
Participant flow
Suspected extrahepatic cholangiocarcinoma (n = 35)
Excluded (n = 14)
Definite inoperable lesion (n = 5)
Poor general condition (n = 6)
Refusal of surgical treatment (n = 3)
Enrollment (n = 21)
Cholangioscopy-guided mapping biopsy
Analysis
Adverse events
none
Outcome measures
Primary Outcome: The primary outcome was the rate of site-based successful biopsies.
A site-based successful biopsy was defined as obtaining epithelium-containing material from all specimens collected at the same site, sufficient for diagnosing benignity or malignancy.
A site-based biopsy was considered unsuccessful if the cholangioscope could not reach the target site or if no specimens were obtained from the target site within 5 min.
The cumulative success rates of obtaining at least one sample of appropriate material on each number of strokes from the major target site were evaluated.
+1
Secondary Outcomes: Secondary outcomes included the success rates of reaching the target sites and the rates of obtaining adequate specimens.
An adequate specimen was defined as the epithelium-containing material that was sufficient for diagnosing benignity or malignancy.
The site-based successful biopsies and the rates of obtaining adequate specimens were compared between patients who had undergone biliary drainage before CMB and those who had not.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047248
