NIPH Clinical Trials Search

Study on the effectiveness of Endoscopic Submucosal Dissection (ESD) using a 3D endoscopy system

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Esophageal tumor, Gastric tumor, Colorectal tumor
Date of first enrollment	2026/06/20
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Endoscopic submucosal dissection (ESD) using a 3D endoscopy system

Outcome(s)

Primary Outcome

Procedure completion rate: The rate of completing ESD using only the 3D endoscopy system from local injection to lesion resection (Assessed during the procedure)

Secondary Outcome

Resection time: Time from the start of local injection to the end of lesion resection (Assessed during the procedure) Dissection speed: Resected specimen diameter divided by resection time (Assessed during the procedure) Endoscopic en bloc resection rate (Assessed during the procedure) Pathological en bloc resection rate (Assessed at the time of pathological evaluation) Intraoperative perforation rate: Confirmed by free gas on X-ray/CT or endoscopically during the procedure (Assessed during the procedure) Postoperative complications: Incidence of bleeding, delayed perforation, etc. (Assessed from immediately after ESD up to 14 days postoperatively) Operator feedback for evaluating fatigue and other factors using Visual Analogue Scale (VAS) (Assessed immediately after the procedure)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria	Patients who meet all of the following inclusion criteria and do not meet any of the exclusion criteria are eligible for enrollment: 1. Patients with lesions suspected to be superficial esophageal cancer, early gastric cancer, early colorectal cancer, esophageal dysplasia, gastric adenoma, or colorectal adenoma based on endoscopic diagnosis. 2. Aged 20 years or older at the time of registration. 3. ECOG Performance Status (PS) of 0 or 1. 4. Lesion size of 50 mm or less. 5. The most recent blood test within 30 days prior to registration meets all of the following conditions (no blood transfusions within 14 days prior to the blood test used for registration): - Hemoglobin >= 9 g/dL - Platelet count >= 100,000/mm3 - AST, ALT <= 100 - Serum creatinine <= 2.0 mg/dL 6. Capable of being followed up for 14 days after treatment. 7. Written informed consent has been obtained for participation in the trial.
Exclude criteria	1. History of endoscopic treatment for upper or lower gastrointestinal tract lesions within 28 days prior to registration. 2. Scheduled for endoscopic treatment for the upper or lower gastrointestinal tract within 14 days after treatment. 3. Planned to treat multiple lesions simultaneously. 4. Background of active inflammatory bowel disease (ulcerative colitis, Crohn's disease). 5. History of radiation therapy in the planned ESD area. 6. Women who are potentially pregnant, currently pregnant, or breastfeeding. 7. Patients with psychiatric symptoms who are unable to sufficiently understand this study. 8. History of myocardial infarction or unstable angina within the past 3 months. 9. Patients with blood coagulation disorders (regardless of antithrombotic drug use). 10. Patients with active bacterial or fungal infections (having a fever of 38.5 degrees C or higher and complicated by bacterial infection confirmed by imaging or bacteriological examination). 11. Patients with respiratory diseases requiring continuous oxygen administration. 12. Patients with poorly controlled hypertension. 13. Other cases where the attending physician judges participation in this study to be inappropriate.