Early Gastric Cancer, Endoscopic Resection
Conditions
Keywords
Endoscopic resection, Early gastric cancer
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.
Interventions
None listed
Sponsors
Shanghai East Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years; 2. histologically proven early gastric adenocarcinoma; 3. meeting the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2021 ; 4. Eastern Cooperative Oncology Group performance status ≤ 2; 5. adequate hematological function (hemoglobin ≥ 9 g/dL, platelets ≥ 50 000/mm3，international normalized ratio\<1.5); 6. 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
1. pregnancy or breastfeeding; 2. difficulty obtaining consent due to psychiatric disorder; 3. multiple lesions; 4. history of gastrectomy or gastrointestinal reconstruction surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | Immediately after surgery | Average time to complete endoscopic resection |
| Circumferential incision time | Immediately after surgery | Average time for APC labeling of the lesion margin during circumferential incision |
| Dissection time | Immediately after surgery | Average time to complete endoscopic dissection |
| Dissection speed | Immediately after surgery | Average speed of endoscopic dissection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of en bloc resection | Immediately after surgery | Number of patients with complete lesion resection / Total number of subjects |
| Adverse event rate | Immediately after surgery and one month post-surgery | The proportion of adverse events occurring in subjects following surgery (though not necessarily causally related to treatment), encompassing perforation complications, myomere injuries, intraoperative blood loss, thermocoagulation forceps replacements, delayed bleeding, and delayed perforation. |
Countries
China
Outcome results
None listed