UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044013 |
|---|---|
| Receipt number | R000050234 |
| Scientific Title | Efficacy of the automatic circular stapler during esophago-gastric anastomosis for minimally invasive esophagectomy |
| Date of disclosure of the study information | 2021/04/30 |
| Last modified on | 2021/04/22 16:12:09 |
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Basic information
Public title
Efficacy of the automatic circular stapler during esophago-gastric anastomosis for minimally invasive esophagectomy
Acronym
Comparison of the circular stapler
Scientific Title
Efficacy of the automatic circular stapler during esophago-gastric anastomosis for minimally invasive esophagectomy
Scientific Title:Acronym
Comparison of the circular stapler
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Compare the Incidence of complications between Proximate ILS and Echelon circular powered stapler during esophago-gastric anastomosis for esophageal cancer with prospective randomized study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of the stenosis, Rate of Dilation
Key secondary outcomes
The ratio of the anastomotic leakage
Difficulty of swallowing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Echelon circular powered stapler
Interventions/Control_2
Proximate ILS
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
1) Over 20 years old
2) The patients that are scheduled minimally invasive esophagectomy and circular stapler when we performed anastomosis.
3) The patients who treating in Gastroenterological and General Surgery or esophageal surgery in Showa University Hospital.
Key exclusion criteria
1) The patients with small physique
2) Heavy obesity patients
3) The patient after Radiation Therapy
4) The patient that is expected high position anastomosis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Otsuka |
Organization
Showa University, School of Medicine
Division name
Division of Gastroenterological and General Surgery, Department of Surgery
Zip code
158-0082
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8541
kojiotsuka@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Motegi |
Organization
Showa University, School of Medicine
Division name
Division of Gastroenterological and General Surgery, Department of Surgery
Zip code
158-0082
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8541
Homepage URL
ken.motegi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterological and General Surgery, Department of Surgery, School of Medicine, Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2021 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | 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=R000050234
