Early Gastric CancerNCT06748352
Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer
A study testing FASTER-assisted ESD and Conventional ESD in people with Early Gastric Cancer and Endoscopic Submucosal Dissection, run by Shandong University at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Gastric Cancer, Endoscopic Submucosal Dissection, Robot Surgery
- What is being tested?
- FASTER-assisted ESD and Conventional ESD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80.
- Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.
Who cannot join
- Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
- Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
- Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
- Patients have lesions with local recurrence after endoscopic resection.
- Patients unable to obtain informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiuli Zuo Professor, MD, PhD, +86 18560080066, zuoxiuli@sdu.edu.cn
About this study
Official title: Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:
Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.
Read more
Participants will:
Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.
Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
- Being tested
- FASTER-assisted ESD, Conventional ESD
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTER-assisted ESDProcedure or surgery
The patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system.
Conventional ESDProcedure or surgery
The patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern.
| Study group | Role | What they receive |
|---|---|---|
| FASTER-assisted ESD group | Experimental | Patients in this group undergo ESD with the assistance of the FASTER system. Receives: Procedure: FASTER-assisted ESD |
| Conventional ESD group | Active comparator | Patients in this group undergo ESD following the clinically established pattern. Receives: Procedure: Conventional ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of muscular injuries
Muscular injury is described as visible damage to the muscularis propria.
Measured: Within 24 hours after the procedure.
Secondary outcomes (11)
the incidence of muscular injury
Muscular injury is described as visible damage to the muscularis propria.
Measured: Within 24 hours after the procedure.
the frequency of intraoperative hemorrhage
Measured: Within 24 hours after the procedure.
the proportion of intraoperative hemorrhage ≥ grade 2
Intraoperative hemorrhage is divided into four grades: Grade 0 means no significant bleeding is observed during the procedure. Grade 1 means minimal bleeding, which could stop spontaneously or be easily controlled by cauterization with a dual knife. Grade 2 refers to minor hemorrhage that requires multiple cauterizations with a dual knife or hemostatic forceps. Grade 3 indicates massive hemorrhage that requires multiple cauterizations with hemostatic forceps.
Measured: Within 24 hours after the procedure.
hemostasis time
Hemostasis time referred to the time from the detection of submucosal bleeding until hemostasis was completed.
Measured: Within 24 hours after the procedure.
the frequency of supplemental injections
Supplemental injection refers to injections performed after the beginning of the dissection.
Measured: Within 24 hours after the procedure.
the supplemental injections time
The time of supplementary injection is from the insertion of the injection needle into the submucosal layer until the injection is completed and the needle is withdrawn.
Measured: Within 24 hours after the procedure.
procedure time
Procedure time is the time from the beginning of injection to the completion of dissection.
Measured: Within 24 hours after the procedure.
dissection time
Dissection time is the time from the beginning of dissection to the completion of dissection.
Measured: Within 24 hours after the procedure.
direct-vision dissection rate
Direct-vision dissection time is the time that the endoscopist can directly observe the tip of the dual knife and the submucosal layer at the same time. By dividing the direct-vision dissection time by the total dissection duration, the direct-vision dissection rate is calculated.
Measured: Within 24 hours after the procedure.
en bloc resection rate
En bloc dissection refers to the complete removal of the entire lesion in a single piece.
Measured: Within 24 hours after the procedure.
R0 resection rate
R0 resection is defined as en bloc resection with negative vertical and horizontal margins.
Measured: Within 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748352
- Sponsor's protocol ID
- SDU-QILU-G015
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06748352
- Acronym / sponsor ID
- SDU-QILU-G015
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:
Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.
Participants will:
Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.
Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FASTER-assisted ESD group | Experimental | Procedure: FASTER-assisted ESDPatients in this group undergo ESD with the assistance of the FASTER system. |
| Conventional ESD group | Active comparator | Procedure: Conventional ESDPatients in this group undergo ESD following the clinically established pattern. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-80.
- Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.
Key exclusion criteria (5 listed)
- Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
- Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
- Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
- Patients have lesions with local recurrence after endoscopic resection.
- Patients unable to obtain informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTER-assisted ESDThe patients who are randomly assigned to the FASTER-assisted ESD group will undergo the ESD procedure with the assistance of the FASTER system. | Procedure or surgery | FASTER-assisted ESD group |
| Conventional ESDThe patients who are randomly assigned to the conventional ESD group will undergo the ESD following the clinically established pattern. | Procedure or surgery | Conventional ESD group |
Primary outcome
the number of muscular injuries
Time frame: Within 24 hours after the procedure.
Muscular injury is described as visible damage to the muscularis propria.
11 secondary outcomes
the incidence of muscular injury
Time frame: Within 24 hours after the procedure.
the frequency of intraoperative hemorrhage
Time frame: Within 24 hours after the procedure.
the proportion of intraoperative hemorrhage ≥ grade 2
Time frame: Within 24 hours after the procedure.
hemostasis time
Time frame: Within 24 hours after the procedure.
the frequency of supplemental injections
Time frame: Within 24 hours after the procedure.
the supplemental injections time
Time frame: Within 24 hours after the procedure.
procedure time
Time frame: Within 24 hours after the procedure.
dissection time
Time frame: Within 24 hours after the procedure.
direct-vision dissection rate
Time frame: Within 24 hours after the procedure.
en bloc resection rate
Time frame: Within 24 hours after the procedure.
R0 resection rate
Time frame: Within 24 hours after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FASTER-assisted ESD and Conventional ESD in people with Early Gastric Cancer and Endoscopic Submucosal Dissection, run by Shandong University 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo Professor, MD, PhD (86+18560080066, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of muscular injuries (time frame: Within 24 hours after the procedure.). 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 27 Dec 2024.