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Clinical Trials/NCT07244471
NCT07244471CompletedNot Applicable

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

Shanghai East Hospital1 site in 1 country548 target enrollmentStarted: January 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
548
Locations
1
Primary Endpoint
Total procedure time

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

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

Outcomes

Primary Outcomes

Total procedure time

Time Frame: Immediately after surgery

Average time to complete endoscopic resection

Circumferential incision time

Time Frame: Immediately after surgery

Average time for APC labeling of the lesion margin during circumferential incision

Dissection time

Time Frame: Immediately after surgery

Average time to complete endoscopic dissection

Dissection speed

Time Frame: Immediately after surgery

Average speed of endoscopic dissection

Secondary Outcomes

  • Completeness of en bloc resection(Immediately after surgery)
  • Adverse event rate(Immediately after surgery and one month post-surgery)

Investigators

Sponsor
Shanghai East Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yingjie Ji

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

Shanghai East Hospital

Study Sites (1)

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