UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033988
Receipt number R000038756
Scientific Title A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection
Date of disclosure of the study information 2018/09/10
Last modified on 2019/06/28 19:48:00

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Basic information

Public title

A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection

Acronym

G-HANDSOME phase I study

Scientific Title

A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection

Scientific Title:Acronym

G-HANDSOME phase I study

Region

Japan


Condition

Condition

early gastric cancers

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility and shortening potential of hospitalization in endoscopic hand suturing for a mucosal defect after gastric endoscopic submucosal dissection

Basic objectives2

Others

Basic objectives -Others

feasibility

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

suture-maintenance rate on the postoperative day 3

Key secondary outcomes

completeness of suturing, postoperative bleeding rate, postoperative minor bleeding rate, adverse events (excluding postoperative bleeding), suturing duration, postoperative bleeding rate with/without anti-thrombotic agents


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

endoscopic hand suturing

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) clinically-diagnosed early gastric cancer/gastric adenoma, 3 cm or less
2) cases which are planned to remove by ESD
3) 20 years-old or more
4) performance status 0-1 according to the ECOG criteria
5) informed consent obtained

Key exclusion criteria

1) bleeding tendency
2) liver cirrhosis (Child-Pugh score: B-C)
3) chronic kidney disease on hemodialysis
4) history of endoscopic treatment 1 month prior to the current study
5) cases in which doctors in charge regarded as unsuitable to inclusion for the current study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Goto

Organization

Nippon Medical School Hospital

Division name

Gastroenterology and Hepatology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan

TEL

03-3822-2131

Email

o-goto@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Goto

Organization

Nippon Medical School Hospital

Division name

Gastroenterology and Hepatology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan

TEL

03-3822-2131

Homepage URL


Email

o-goto@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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 09 Month 10 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

2018 Year 08 Month 10 Day

Date of IRB

2018 Year 08 Month 10 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2019 Year 06 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 01 Day

Last modified on

2019 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name