UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031244 |
|---|---|
| Receipt number | R000035672 |
| Scientific Title | A randomized trial estimating the efficiency of drainage around the cervical anastomosis in esophagectomy for esophageal cancer (Transitioned to jRCT) |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2023/02/15 10:46:53 |
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Basic information
Public title
A randomized trial estimating the efficiency of drainage around the cervical anastomosis in esophagectomy for esophageal cancer (Transitioned to jRCT)
Acronym
A randomized trial estimating the efficiency of drainage around the cervical anastomosis in esophagectomy for esophageal cancer
Scientific Title
A randomized trial estimating the efficiency of drainage around the cervical anastomosis in esophagectomy for esophageal cancer (Transitioned to jRCT)
Scientific Title:Acronym
A randomized trial estimating the efficiency of drainage around the cervical anastomosis in esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to improve the noninferiority of drainage tube detention to non-detention in anastomotic leakage rate for clinical stage I/II/III esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anastomotic leakage rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Detention of the silicon drain around the cervical anastomosis
Interventions/Control_2
Intervention period is less than 14days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The diagnosis of esophageal cancer(squamous cell carcinoma, adenosquamous cell carcinoma, basaloid carcinoma) was based on the seventh edition of the Union for International Cancer Control (UICC) tumor node metastasis (TNM) cancer staging system. In this study, inclusion criteria included thoracic esophageal cancer, multiple esophageal cancer, age 18-75 years; cStage I-III disease (without T4); and Informed consent was obtained from all individual participants included in the study.
Key exclusion criteria
Patients who don't satisfied above criteria should be excluded.
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Oshikiri |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastrointestinal Surgery, Department of Surgery,
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017
TEL
078-382-5925
urotarikishio@gmail.com
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Oshikiri |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastrointestinal Surgery, Department of Surgery,
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017
TEL
078-382-5925
Homepage URL
urotarikishio@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Kobe University
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
Kobe University Clinical Research Review Committee
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017
Tel
078-382-6669
cerb@med.kobe-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
| 2018 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transitioned to jRCT, jRCTs1052180016
Management information
Registered date
| 2018 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
