Colorectal tumor Colorectal tumor
Conditions
Interventions
Colorectal ESD is performed under water immersion by filling the intestinal lumen with saline irrigation. The ESD procedure consists of three steps: (1) submucosal injection, (2) circumferential incis
endoscopic submucosal dissection
Sponsors
Yoshizaki Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Lesions eligible for ESD according to the Colorectal ESD/EMR Guidelines (2nd edition), meeting any of the following criteria: i) Lesions difficult to resect en bloc by snare EMR, including: LST-NG, especially the pseudo-depressed type Lesions with a type VI pit pattern T1 (SM) slightly invasive carcinoma Large depressed-type tumors Large elevated lesions suspected of carcinoma ii) Intramucosal tumors with submucosal fibrosis iii) Sporadic localized tumors arising in the background of chronic inflammation, such as ulcerative colitis iv) Local residual early carcinoma after prior endoscopic resection (2) Patients aged 18 years or older at the time of consent acquisition. (3) Patients who have provided written informed consent for participation in this clinical study based on their own free will.
Exclusion criteria
Exclusion criteria: (1) Patients who have previously been enrolled in this clinical study for a different lesion. (2) Patients on antithrombotic therapy who cannot discontinue their medication in accordance with the Endoscopy Guidelines for Antithrombotic Agents and its 2017 Supplement. (3) Patients with severe heart failure (NYHA class III or IV). (4) Other patients deemed inappropriate for inclusion by the investigators of this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time during which 30% of the endoscopic field is occupied by bubbles per discharge during immersion procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time (Time from the start of submucosal injection to the completion of lesion resection) Immersion procedure time (Duration of the procedure performed under water immersion) Whether or not to perform En bloc resection Whether or not to perform en bloc R0 resection (Lesion resected en bloc with negative resection margins) Number of discharges (Number of times the electrosurgical device was activated) Time during which 50% of the endoscopic field is occupied by bubbles Time during which 50% of the endoscopic field is occupied by bubbles per discharge during immersion procedure Time during which 30% of the endoscopic field is occupied by bubbles Time during which bubbles are present in the endoscopic field Time during which bubbles are present in the endoscopic field per discharge during immersion procedure Intraoperative perforation Delayed perforation Postoperative bleeding Post-ESD electrocoagulation syndrome Diarrhea Electrolyte imbalance | — |
Contacts
Public ContactTetsuya Yoshizaki
Kobe University hospital
Outcome results
None listed