UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029566 |
|---|---|
| Receipt number | R000033782 |
| Scientific Title | Randomized phase II study of thoracic duct resection versus preservation in radical esophagectomy for cStageI thoracic esophageal cancer |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2025/04/22 09:09:00 |
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Basic information
Public title
Randomized phase II study of thoracic duct resection versus preservation in radical esophagectomy for cStageI thoracic esophageal cancer
Acronym
thoracic duct resection versus preservation in radical esophagectomy
Scientific Title
Randomized phase II study of thoracic duct resection versus preservation in radical esophagectomy for cStageI thoracic esophageal cancer
Scientific Title:Acronym
thoracic duct resection versus preservation in radical esophagectomy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the usefulness of thoracic duct preservation compared with thoracic duct resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total volume of drain for 3 days after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
thoracic duct preservation/
Interventions/Control_2
thoracic duct resection
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
cStageI esophageal cancer
Key exclusion criteria
liver fibrosis, liver cirrhosis, liver damage Child-Pugh B and C
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Department of Gastroenterological Surgery
Graduate School of Medicine
Osaka University
Division name
Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
5650871
Address
2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Tanaka |
Organization
Department of Gastroenterological Surgery Graduate School of Medicine Osaka University
Division name
Department of Gastroenterological Surgery Graduate School of Medicine
Zip code
5650871
Address
2-2 Yamadaoka, E2, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
ktanaka@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
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
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6210-8270
handai-nintei@hp-crc.med.osaka-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 | 10 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033782
