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

NCT07244471 | Completed DMC

• 1 other identifier: 20250612IIT0068
• Study Type: observational
• Target: 548
• Locations: 1 country
• Sites: 1

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

Keywords

Endoscopic resection; Early gastric cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Completeness of en bloc resection

  Immediately after surgery

• Adverse event rate

  Immediately after surgery and one month post-surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• pregnancy or breastfeeding;
• difficulty obtaining consent due to psychiatric disorder;
• multiple lesions;
• history of gastrectomy or gastrointestinal reconstruction surgery.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, Shanghai East Hospital, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)