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A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.

A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia. - A randomized controlled trial comparing traction ESD with the S-O clip versus conventional ESD for gastric epithelial neoplasia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025125
Enrollment
90
Registered
2016-12-30
Start date
2016-12-30
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 cancer/gastric adenoma

Interventions

A: traction ESD with the S-O clip group B: Conventional ESD group

Sponsors

Sendai Kousei Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenoma or cancer, which is within the absolute or expanded indication of ESD according to Japanese gastric cancer treatment guideline 2014. 2) No gastrectomy and no reconstructive surgery of gastric tube for esophageal cancer. 3) Aged 20 years old or more. 4) ECOG performance status of 0, 1 or 2. 5) Predicted line of mucosal incision is not on the EG junction. 6) Predicted line of mucosal incision is not on the pylorus. 7) Follow up for 60 days after ESD. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who are disqualified for this study by physicians 2) Patients with the possibility of the pregnancy or the pregnancy 3) Patients who are lactating

Design outcomes

Primary

MeasureTime frame
ESD procedure time

Secondary

MeasureTime frame
Adverse events(delayed bleeding/perforation), ESD procedure time according to the location of the lesion, the proficiency of the operator (trainee or expert)and the presence of ulcer findings; en bloc resection rate; complete en bloc resection rate; amount of submucosal injection

Countries

Japan

Contacts

Public ContactRintaro Hashimoto

Sendai Kousei Hospital Department of Gastroenterology

rhashimoto@sendai-kousei-hospital.jp022-222-6181

Outcome results

None listed

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