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Completed

NCT Number: NCT07453433

Submucosal Pressure Ejection Endoscopic 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 submucosal pressure ejection endoscopic dissection (SPEED) to treat early gastric cancer and compare the efficacy and safety with conventional methods.

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Key information

Conditions

Endoscopic Resection Digestive System Diseases Digestive System Neoplasms Early Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai East Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Total procedure time

    Time frame: Immediately after surgery

    Average time to complete endoscopic resection

  2. Circumferential incision time

    Time frame: Immediately after surgery

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

  3. Dissection time

    Time frame: Immediately after surgery

    Average time to complete endoscopic dissection

  4. Dissection speed

    Time frame: Immediately after surgery

    Average speed of endoscopic dissection

Secondary outcomes

  1. Completeness of en bloc resection

    Time frame: Immediately after surgery

    Number of patients with complete lesion resection / Total number of subjects

  2. Adverse event rate

    Time frame: Immediately after surgery and one month post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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