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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033988

Enrollment

Registered

2018-09-10

Start date

2018-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early gastric cancers

Interventions

endoscopic hand suturing

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
suture-maintenance rate on the postoperative day 3	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactOsamu Goto

Nippon Medical School Hospital Gastroenterology and Hepatology

o-goto@nms.ac.jp03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026