Colorectal tumor
Conditions
Interventions
Conventional ESD group
Band-assisted ESD group
Sponsors
St. Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Early colorectal cancer, size: > 20mm and <= 30mm, depth of cancer invasion: M or SM1. 2)Adequate organ functions defined as; Hemoglobin of 8.0 g/dl or more Platelet count 100,000 or more 3)Aged 20 years old or more 4)PS(ECOG), 0 or 1. 5)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with lesions in the Rb. 2)Patients with multiple lesions to be treated. 3)Patients with a bleeding tendency. 4)Patients deviating from the "Gastrointestinal endoscopy practice guidelines for antithrombotic drug recipients (including supplements)" and patients who cannot comply. 5)During dialysis. 6)Inflammatory bowel disease or familial adenomatous polyposis. 7)Lesion on the endoscopic resection scar (EMR or ESD) 8)Past history of colectomy or radiotherapy. 9)Patient considered unsuitable for a clinical trial as determined by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of submucosal resection during colorectal ESD | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time of colorectal ESD, Adverse event during ESD, Adverse event after ESD, Colorectal ESD procedure time and adverse events for each operator, Procedure time according to macroscopic type, Pathological assessment (size, adenoma or cancer, depth of cancer, en bloc resection rate, complete en bloc resection rate) Time required to attach band | — |
Countries
Japan
Contacts
Public ContactYasumasa Matsuo
St. Marianna University School of Medicine Toyoko Hospital Gastroenterology and Hepatology
Outcome results
None listed