Gastric neoplasm
Conditions
Interventions
When assigned to the standard treatment group (group A), conventional ESD is performed.
When assigned to the study treatment group (group B), hybrid ESD is performed.
Sponsors
Graduate School of Medicine, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female aged 20 years with early gastric neoplasm who will undergo endoscopic resection as a local treatment -Eligible lesion is diagnosed as a gastric adenoma or adenocarcinoma by endoscopic biopsy within 90 days before enrollment. -Eligible lesion is endoscopically diagnosed as a mucosal lesion within 20 mm in diameter without ulceration. -Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of each eligible patient is 0, 1, or 2. -Eligible patients will be asked to listen to oral explanation and read explanatory documents providing doctors' instruction and sign consent forms. Informed consent will be obtained from each eligible patient before enrollment in the trial -Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria
Exclusion criteria: -Patients with a history of gastric surgery -Patients on dialysis -Patients requiring continuous administration of heparin during perioperative period. -Contraindication with endoscopy; ileus, gastrointestinal perforation or severe respiratory/cardiac disease. -Metal allergy -Patients who are judged inappropriate by physician participating in this trial -Patients who cannot obtain informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure time of ESD | — |
Secondary
| Measure | Time frame |
|---|---|
| Time and speed of mucosal incision Time and speed of submucosal dissection with or without snaring En bloc and complete resection Curability judged by histological assessment of resected specimen Endoscopic procedural adverse events including intraoperative perforation, delayed perforation and delayed bleeding Degree of dissected submucosal layer before snaring Volume of injective solution Number and time of hemostasis using hemostatic device during procedure Thickness of submucosal layer in resected specimen The relationship between outcomes and morphology / location / size/ ulceration / operator's experience. | — |
Countries
Japan
Contacts
Public ContactMitsuru Esaki
Graduate School of Medicine, Kyushu University Department of Medicine and Bioregulatory Science
Outcome results
None listed