Study of endoscopic resection of endoscopic submucosal tumors

JRCT ID: jRCT1030230058

Registered date:29/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Submucosal Tumor
• Date of first enrollment: 29/04/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Under general anesthesia and with a surgeon on call, the lesion is resected by endoscopic full thickness resection (EFTR).

Outcome(s)

• Primary Outcome: Adverse event rate

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yano Tomonori