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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044013
Receipt No. 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

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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
Email 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
Email ken.motegi@med.showa-u.ac.jp

Sponsor
Institute Showa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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