UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019585
Receipt number R000022640
Scientific Title Endoscopic evaluation for the postoperative condtion after esophagectomy and reconstruction
Date of disclosure of the study information 2015/10/31
Last modified on 2018/02/25 11:32:14

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Basic information

Public title

Endoscopic evaluation for the postoperative condtion after esophagectomy and reconstruction

Acronym

Endoscopic evaluation after esophagectomy

Scientific Title

Endoscopic evaluation for the postoperative condtion after esophagectomy and reconstruction

Scientific Title:Acronym

Endoscopic evaluation after esophagectomy

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastrointestinal surgery Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The safe and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse effects of endoscopic examination for 1 months after intervention
The success rate of endoscopic examination for 1 months after intervention

Key secondary outcomes

The potential efficacy of endoscopic examination


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Postoperative endoscopic examination (1-29POD)
Intraoperative examination of blood flow

Interventions/Control_2


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 patients of esophagectomy

Key exclusion criteria

Poor general condition.
Allergic constitution.
Pregnancy
Enrolling other intensive clinical researches
before 4 months
Exclusion by research representative

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eguchi Susumu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Surgery

Zip code


Address

Sakamoto 1-7-1, Nagasaki city

TEL

+81958197316

Email

sueguchi@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Kobayashi

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Surgery

Zip code


Address

Sakamoto 1-7-1, Nagasaki city

TEL

+81958197316

Homepage URL


Email

shinichirokobayashi@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Graduate School of Biomedical Sciences
Grant-in-Aid for Scientific Research from JSPS

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

長崎大学病院(長崎県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 31 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

Completed

Date of protocol fixation

2015 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2016 Year 12 Month 30 Day

Date of closure to data entry

2016 Year 12 Month 30 Day

Date trial data considered complete

2016 Year 12 Month 30 Day

Date analysis concluded

2018 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 31 Day

Last modified on

2018 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022640


Research Plan
Registered date File name
2016/10/17 EK計画書-1_rin1_(2).doc

Research case data specifications
Registered date File name

Research case data
Registered date File name