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

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 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

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

Value
https://center6.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