UMIN-CTR Clinical Trial

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