CompletedNot Applicable

Submucosal Pressure Ejection Endoscopic 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 submucosal pressure ejection endoscopic dissection (SPEED) 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 IDNCT07453433

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.