Tokyo, March 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060952) titled 'Radiographic Evaluation as a Proxy for Endoscopic Assessment of Post-ESD Clip Closure after Gastric ESD: Prospective Observational Study' on March 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Omori Red Cross Hospital
Condition:
Condition - Early gastric cancer and gastric adenoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To validate the reliability of radiographic assessment of closure maintenance after clip closure following gastric ESD, the number of clips will be confirmed on both follow-up radiographic examination and endoscopic evaluation, and the findings will be compared.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Abdominal X-ray examination
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients with lesions suspected to be early gastric cancer or gastric adenoma based on endoscopic diagnosis.
2. Lesions in which the post-resection mucosal defect does not extend to the esophagus or the duodenum.
3. Lesions measuring less than 50 mm in diameter.
Key exclusion criteria - 1. A history of endoscopic treatment for upper gastrointestinal lesions within 28 days prior to enrollment.
2. Planned concomitant endoscopic treatment for esophageal or duodenal lesions.
3. Women who are pregnant, may be pregnant, or are breastfeeding.
4. Patients with psychiatric disorders that preclude adequate understanding of the study.
5. Patients with a history of gastric surgical resection.
6. Patients who have undergone gastric tube reconstruction.
7. Patients deemed unsuitable for participation in this study by the attending physician or the investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 01 Month 29 Day
Date of IRB - 2026 Year 02 Month 20 Day
Anticipated trial start date - 2026 Year 03 Month 16 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069550
Disclaimer: Curated by HT Syndication.