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

NCT ID: NCT07244471

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 548 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Endoscopic Resection; Early Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Water-injecting ESD

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).

No interventions assigned to this group

Conventional ESD

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yingjie Ji

Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

20250612IIT0068

Identifier Type: -

Identifier Source: org_study_id