UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012915
Receipt number R000015098
Scientific Title Assessment of resected specimen size after endoscopic submucosal dissection (ESD) among endoscopists when putting it on specimen board
Date of disclosure of the study information 2014/01/21
Last modified on 2015/04/20 19:35:12

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Basic information

Public title

Assessment of resected specimen size after endoscopic submucosal dissection (ESD) among endoscopists when putting it on specimen board

Acronym

Measurement error of tumor size among endoscopists

Scientific Title

Assessment of resected specimen size after endoscopic submucosal dissection (ESD) among endoscopists when putting it on specimen board

Scientific Title:Acronym

Measurement error of tumor size among endoscopists

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to confirm that the resected tumor specimen is putted the specimen board correctly and no measurement error among endosocpists.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The differences of maximum resected tumor size and its vertical tumor size among three endoscopists.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

5 endoscopists among 7 endoscopists except for 2 endoscopists who performed ESD were randomized and selected 3 endoscopists using sealed envelope method. Endoscopist1 put the resected specimen one by one, and measured maximum tumor size and maximum vertical size of the specimen. After putting it out from the specimen board, next endoscopist do the same procedures and recorded the sizes.

Interventions/Control_2

Endoscopist2 put the resected specimen one by one, and measured maximum tumor size and maximum vertical size of the specimen. After putting it out from the specimen board, next endoscopist do the same procedures and recorded the sizes.

Interventions/Control_3

Endoscopist3 put the resected specimen one by one, and measured maximum tumor size and maximum vertical size of the specimen.Endoscopist 3give pathologists this specimen 3 and are true size of resected specimen.

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who were diagnosed with eraly gastric cancer as expanding criteria of ESD definited by Japanese Gastric Cancer Association(JGCA).

Key exclusion criteria

Patients who were diagnosed with eraly gastric cancer of exclusion criteria of ESD definited by Japanese Gastric Cancer Association(JGCA).

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirohito Mori

Organization

Ehime Rousai Hospital

Division name

Department of Gastroenterological Surgery

Zip code


Address

13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan

TEL

0897-33-6191

Email

hiro4884@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Yamashita

Organization

Ehime Rousai Hospital

Division name

Medical Affairs Division

Zip code


Address

13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan

TEL

0897-33-6191

Homepage URL


Email

ijikachou@ehimerosai.jp


Sponsor or person

Institute

Department of Gastroenterological Surgery, Ehime Rosai Hospital, 13-27, Minamikomatsubara, Niihama, Ehime 792-8550, Japan

Institute

Department

Personal name



Funding Source

Organization

kagawa University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 21 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

2014 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 21 Day

Last modified on

2015 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name