CompletedNot Applicable

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

China548 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Total procedure time

Timeframe: Immediately after surgery

Circumferential incision time

Timeframe: Immediately after surgery

Dissection time

Timeframe: Immediately after surgery

Dissection speed

Timeframe: Immediately after surgery

Trial details

NCT IDNCT07244471

SponsorShanghai East Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Endoscopic Resection trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.