Endoscopic ResectionNCT07453433
Submucosal Pressure Ejection Endoscopic Dissection for Early Gastric Cancer: a Retrospective Cohort Study
An observational study of Endoscopic Resection and Early Gastric Cancer, run by Shanghai East Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Resection, Early Gastric Cancer
- Type of treatment
- Injection or infusion
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who underwent ESD for EGC were enrolled at Shanghai East Hospital between January 2019 and December 2024.
Who may be able to join
- 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).
Who cannot join
- pregnancy or breastfeeding;
- difficulty obtaining consent due to psychiatric disorder;
- multiple lesions;
- history of gastrectomy or gastrointestinal reconstruction surgery.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Endoscopic Resection, Early Gastric Cancer
- Keywords
- Endoscopic Resection, Early gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Submucosal pressure ejection endoscopic dissection (SPEED) | 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). | |
| Conventional ESD (C-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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedure time
Average time to complete endoscopic resection
Measured: Immediately after surgery
Circumferential incision time
Average time for APC labeling of the lesion margin during circumferential incision
Measured: Immediately after surgery
Dissection time
Average time to complete endoscopic dissection
Measured: Immediately after surgery
Dissection speed
Average speed of endoscopic dissection
Measured: Immediately after surgery
Secondary outcomes (2)
Completeness of en bloc resection
Number of patients with complete lesion resection / Total number of subjects
Measured: Immediately after surgery
Adverse event rate
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.
Measured: Immediately after surgery and one month post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jan 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingjie Ji, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453433
- Sponsor's protocol ID
- 2025YS-205
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submucosal Pressure Ejection Endoscopic Dissection for Early Gastric Cancer: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07453433
- Acronym / sponsor ID
- 2025YS-205
- Conditions
- Endoscopic Resection, Early Gastric Cancer
- Keywords
- Endoscopic Resection, Early gastric cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Submucosal pressure ejection endoscopic dissection (SPEED) | – | –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). |
| Conventional ESD (C-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who underwent ESD for EGC were enrolled at Shanghai East Hospital between January 2019 and December 2024.
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (4 listed)
- pregnancy or breastfeeding;
- difficulty obtaining consent due to psychiatric disorder;
- multiple lesions;
- history of gastrectomy or gastrointestinal reconstruction surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Completeness of en bloc resection
Time frame: Immediately after surgery
Adverse event rate
Time frame: Immediately after surgery and one month post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Resection and Early Gastric Cancer, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedure time (time frame: Immediately after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.