UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038140
Receipt number R000043472
Scientific Title A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents
Date of disclosure of the study information 2019/11/01
Last modified on 2024/03/04 22:07:06

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Basic information

Public title

A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents

Acronym

Multi-centered Phase II trial on endoscopic hand suturing after gastric ESD in patients with antithrombotic agents

Scientific Title

A multi-centered phase II study of efficacy in endoscopic HAND Suturing (EHS) Of Mucosal defects after Gastric Endoscopic submucosal dissection in patients with anti-thrombotic agents

Scientific Title:Acronym

G-HANDSOME phase II study

Region

Japan


Condition

Condition

Early gastric cancers

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of endoscopic hand suturing after gastric endoscopic submucosal dissection in patients with antithrombotic agents

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Delayed bleeding rate in postoperative week 3-4

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1)A single early gastric cancer, 3cm or less
2)A candidate for ESD
3)Patients taking Antithrombotic agents continuously
4)Patients with the higher risk of thrombotic events compared to the risk of postoperative bleeding
5)20 years old or more
6)PS 0-1
7)Informed consent obtained

Key exclusion criteria

1)Lesions in remnant stomach after surgery
2)Patients with bleeding tendency
3)Liver cirrhosis (Child-Pugh B-C)
4)Chronic kidney disease on hemodialysis
5)Past history of endoscopic treatment within 1 month
6)Inappropriate cases for the recruitment suggested by doctors in charge

Target sample size

48


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Goto

Organization

Nippon Medical School Hospital

Division name

Gastroenterology and Hepatology

Zip code

113-8603

Address

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

TEL

0338222131

Email

o-goto@nms.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Goto

Organization

Nippon Medical School

Division name

Gastroenterology and Hepatology

Zip code

113-8603

Address

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

TEL

0338222131

Homepage URL


Email

o-goto@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nippon Medical School Hospital Center for Clinical Research

Address

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

Tel

0338222131

Email

inq-ccr@nms.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



Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 01 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

49

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

2019 Year 09 Month 27 Day

Date of IRB

2021 Year 04 Month 05 Day

Anticipated trial start date

2021 Year 04 Month 10 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 10 Month 02 Day


Other

Other related information



Management information

Registered date

2019 Year 09 Month 27 Day

Last modified on

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043472


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name