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

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 - G-HANDSOME phase II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038140

Enrollment

Registered

2019-11-01

Start date

2021-04-10

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)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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Delayed bleeding rate in postoperative week 3-4	—

Countries

Japan

Contacts

Public ContactOsamu Goto

Nippon Medical School Gastroenterology and Hepatology

o-goto@nms.ac.jp0338222131

Outcome results

None listed

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