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

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 Overview

• Status: Completed
• Conditions: Early Gastric Cancer; Endoscopic Resection

• Study Type: Observational
• Enrollment (Actual): 548

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, Shanghai East Hospital
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent ESD for EGC were enrolled at Shanghai East Hospital between January 2019 and December 2024.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time	Average time to complete endoscopic resection	Immediately after surgery
Circumferential incision time	Average time for APC labeling of the lesion margin during circumferential incision	Immediately after surgery
Dissection time	Average time to complete endoscopic dissection	Immediately after surgery
Dissection speed	Average speed of endoscopic dissection	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completeness of en bloc resection	Number of patients with complete lesion resection / Total number of subjects	Immediately after surgery
Adverse event rate	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.	Immediately after surgery and one month post-surgery

Collaborators and Investigators

• Sponsor: Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Early gastric cancer; Endoscopic resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 20250612IIT0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No