Colorectal neoplasms
Conditions
Interventions
In the intevention arm, the supervising physician will provide verbal instructions to ensure that the operator'
s gaze position is appropriate. During mucosal incision, the operators will be instructed to correct the viewpoint position in real time so that they can gaze exactly 5 mm from the lesion margins.
In
Sponsors
International University of Health and Welfare Ichikawa Hospital
NTT Medical Center Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for ESD practitioners (training physicians) 1. Trainee physicians performing ESD under the education of a supervising physician (CS experience of at least 500 cases, cecal insertion success rate of at least 95%, and polypectomy experience of at least 100 cases) 2. Physicians with less than 5 ESD experiences as an operator at the time of entry into the study 3. Physicians who have been fully informed of the study participation and have obtained written consent from them. Inclusion criteria for ESD patients 1. Patients aged between 20 and 90 years old. 2. Patients with performance status (ECOG) of 0 (no limitation in daily activities), 1 (able to perform light work but not physical labor), or 2 (able to walk and perform personal activities but not light work). 3. Patients has been fully informed of the study and has given written consent to participate in the study 4. Patients with colorectal lesions that are eligible for ESD and have a lesion diameter of 50 mm or less
Exclusion criteria
Exclusion criteria: Exclusion criteria for ESD patients 1. Patients with lesions located in areas where endoscopic manipulation is difficult (hepatic or splenic kyphosis, etc.) 2. Patients with lesions with large elevations and fibrosis directly under the lesion 3. Patients with lesions that straddle the mucosal folds 4. Patients with lesions on or near the scar 5. Patients with lesions that the supervising physician determines unsuitable for the practitioner to treat as an operator 6. Patients who are allergic to sedative medications 7. Patients who do not consent to participate in the study 8. Patients who are deemed unsuitable by the study registrar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of variation of distance between lesion and specimen margins | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time required for resection 2. Average resection speed 3. R0 resection rate 4. Complete en bloc resection rate 5. Complication (bleeding, perforation) rate 6. ESD completion rate 7. Change of each endpoint in 5 early and 5 late cases | — |
Countries
Japan
Contacts
Public ContactIshibashi Fumiaki
International University of Health and Welfare Ichikawa Hospital Department of Gastroenterology
Outcome results
None listed