Water-injecting Endoscopic Submucosal Dissection for Early Gastric Cancer: a Retrospective Cohort Study

Tongji University

Status: Completed

Conditions: Early Gastric Cancer; Endoscopic Resection

Study type: Observational

Funder types: Other

Identifiers

NCT07244471

20250612IIT0068

Details and patient eligibility

About

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.

Enrollment: 548 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

548 participants in 2 patient groups

Water-injecting ESD

Description:

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).

Conventional ESD

Description:

A traditional ESD model. Submucosal injection is performed separately from circumferential cutting, dissection, electrocoagulation, and hemostasis. During the submucosal dissection procedures, submucosal injection is performed with the tip of the knife first, followed by the above operations, rather than simultaneously.