Water-injecting Endoscopic Submucosal Dissection for Early Gastric Cancer: a Retrospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 548
- Locations
- 1
- Primary Endpoint
- Total procedure time
Study Overview
Brief Summary
Endoscopic submucosal dissection (ESD) is a technically difficult and time-consuming procedure. Several water-jet knives have been developed to address this issue. The aim of this study was to develop a new ESD method using continuous low-pressure water injection at 1-2 atmosphere with a tip-injected electric knife while dissection simultaneous cutting, dissection, electrocoagulation, and hemostasis, which was so called as water-injecting ESD (W-ESD) to treat early gastric cancer and compare the efficacy and safety with conventional methods.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18 years;
- •histologically proven early gastric adenocarcinoma;
- •meeting the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2021 ;
- •Eastern Cooperative Oncology Group performance status ≤ 2;
- •adequate hematological function (hemoglobin ≥ 9 g/dL, platelets ≥ 50 000/mm3，international normalized ratio<1.5);
- •sufficient renal function (serum creatinine ≤ 2.0 mg/dL); and (7) adequate hepatic function (serum aspartate aminotransferase ≤ 100 IU/L, serum alanine aminotransferase ≤ 100 IU/L).
Exclusion Criteria
- •pregnancy or breastfeeding;
- •difficulty obtaining consent due to psychiatric disorder;
- •multiple lesions;
- •history of gastrectomy or gastrointestinal reconstruction surgery.
Outcomes
Primary Outcomes
Total procedure time
Time Frame: Immediately after surgery
Average time to complete endoscopic resection
Circumferential incision time
Time Frame: Immediately after surgery
Average time for APC labeling of the lesion margin during circumferential incision
Dissection time
Time Frame: Immediately after surgery
Average time to complete endoscopic dissection
Dissection speed
Time Frame: Immediately after surgery
Average speed of endoscopic dissection
Secondary Outcomes
- Completeness of en bloc resection(Immediately after surgery)
- Adverse event rate(Immediately after surgery and one month post-surgery)
Investigators
Yingjie Ji
Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital
Shanghai East Hospital