UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029888 |
|---|---|
| Receipt number | R000034139 |
| Scientific Title | Clinical efficacy of intraoperative peritoneal lavage cytology in biliary tract cancer |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2020/12/09 23:11:08 |
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Basic information
Public title
Clinical efficacy of intraoperative peritoneal lavage cytology in biliary tract cancer
Acronym
Clinical efficacy of intraoperative peritoneal lavage cytology in biliary tract cancer
Scientific Title
Clinical efficacy of intraoperative peritoneal lavage cytology in biliary tract cancer
Scientific Title:Acronym
Clinical efficacy of intraoperative peritoneal lavage cytology in biliary tract cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this retrospective multiinstitutional study is to evaluate the clinical efficacy of intraoperative peritoneal lavage cytology (CY) in biliary tract cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Recurrence free survival
Recurrence site
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
All patients diagnosed with biliary tract cancer based on diagnostic imagings or pathological diagnosis are included in this study.
Key exclusion criteria
Patients with other cancers and deceased patients within perioperative period are excluded.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsukuma |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
smatsu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
Kansai Hepatobiliary Oncology Group (KHBO)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute review board, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
Tel
0836222428
clin_res@yamaguchi-u.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
| 2017 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
http://ds26.cc.yamaguchi-u.ac.jp/~crc-di/clin_res/homepage/doc/public_format/H29-094.pdf
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/cnr2.1323
Number of participants that the trial has enrolled
169
Results
Of 169 patients who underwent curative resection, 164 were cytology-negative,
and five were cytology-positive. The incidence of peritoneal metastatic recurrence
was also higher, and overall survival tended to be worse in the cytology-positive
group. In contrast, recurrence-free survival was similar between the cytology-negative
and cytology-positive groups.
Results date posted
| 2020 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 06 | Day |
Baseline Characteristics
Clinicopathological data of patients with BTCs who underwent treatment from January 2013 to January 2016 were collected from 11 institutions in Japan.
Participant flow
One-hundred and sixty nine patients were enrolled in this study.
Adverse events
none
Outcome measures
The difference between patients who underwent curative resection with and without cytology positive in the cumulative incidence of peritoneal metastatic recurrence, recurrence free survival and overall survival. The association between cytology positive and macroscopic peritoneal metastasis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
To analyze and compare overall survival, recurrence free survival and recurrece site in patients with positive/negative CY.
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034139
