UMIN-CTR Clinical Trial

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
Institute	Nippon Medical School
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038756