UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032713
Receipt number R000037303
Scientific Title Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection
Date of disclosure of the study information 2018/06/07
Last modified on 2018/06/07 23:08:41

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Basic information

Public title

Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection

Acronym

Strategy of ESD for gastric cancer at great curvature

Scientific Title

Endoscopic submucosal dissection for neoplasia of the greater curvature of the upper and middle stomach: J-shaped superficial cutting and splashed dissection

Scientific Title:Acronym

Strategy of ESD for gastric cancer at great curvature

Region

Japan


Condition

Condition

Early Gastric cancer,adenoma

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of the J-shaped superficial cutting and splashed submucosal dissection (JSCS) technique for neoplasia of the greater curvature by comparing ESD using JSCS with conventional ESD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary outcome was the en bloc resection rate.

Key secondary outcomes

Secondary outcomes included complete resection (R0) rate, procedure time, perforation rate, total bleeding time, and the total number massive bleeding events and number of times hemostatic forceps were used during ESD.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Gastric neoplasia included early gastric cancer and adenoma that could not be preoperatively distinguished from early gastric cancer. ESD was indicated for early gastric cancer in which the invasion depth was expected to be less than slightly submucosal and there was no possible lymph node metastasis, based on Japanese ESD criteria. The inclusion criterion was a lesion affecting the greater curvature of the upper and middle body of the stomach.

Key exclusion criteria

The patient who does not agree with this study.And the cancer suitable for surgery rather than ESD by following EGD,and UL positive.

Target sample size

54


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriko Nishiyama

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Gastroenterology

Zip code


Address

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan

TEL

087-891-2156

Email

n-nori@med.kagawa-ua.c.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriko Nishiyama

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Gastroenterology

Zip code


Address

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan

TEL

087-891-2156

Homepage URL


Email

n-nori@med.kagawa-ua.c.jp


Sponsor or person

Institute

Faculty of Medicine, Kagawa University

Institute

Department

Personal name



Funding Source

Organization

Faculty of Medicine, 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

2018 Year 06 Month 07 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

2008 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 05 Month 24 Day

Last modified on

2018 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037303


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name