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Study of endoscopic resection of endoscopic submucosal tumors

Feasibility study of Endoscopic Full-thickness resection (EFTR) for gastric submucosal tumor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030230058
Enrollment
5
Registered
2023-04-29
Start date
2023-04-29
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

Gastric Submucosal Tumor Gastric Submucosal Tumor

Interventions

Under general anesthesia and with a surgeon on call, the lesion is resected by endoscopic full thickness resection (EFTR).

Sponsors

Yano Tomonori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Gastric submucosal tumor diagnosed on imaging 2.Age 18 years or older, but less than 85 years old 3.ASA II or less 4.Less than 3 cm in size 5.Contiguous to the muscularis mucosae on imaging and growing predominantly into the lumen 6.Histological diagnosis is not required, but the lesion meets one of the following criteria

Exclusion criteria

Exclusion criteria: 1. Lesions with ulceration 2. Patients who cannot give consent based on their own judgment 3. Patients in which lymph node metastasis is suspected in the preoperative examination 4. No active overlapping cancer (synchronous overlapping cancer and iatrogenic overlapping cancer with a disease-free period of 5 years or less). 5.Infectious disease requiring systemic treatment. GIST histologically diagnosed. SMT without histological diagnosis that is larger than 2 cm in size or has malignant findings on imaging.

Design outcomes

Primary

MeasureTime frame
Adverse event rate

Secondary

MeasureTime frame
1. Endoscopic en bloc resection rate: Percentage of all registered cases that were endoscopically en bloc resected. 2. Complete histological resection rate: Percentage of patients who were able to undergo complete histological resection among all enrolled patients. 3. Percentage of patients with histological capsular damage: Percentage of patients with capsular damage among all registered cases. 4. Percentage of cases in which the procedure was completed by endoscopy alone out of all registered cases. 5. Treatment time 6. Duration of hospitalization

Contacts

Public ContactHironori Sunakawa

National Cancer Center Hospital East

hsunakaw@east.ncc.go.jp+81-4-7133-1111

Outcome results

None listed

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