Endoscopic ResectionESISD vs CESDNCT07236827
A Comparison of Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventional Endoscopic Submucosal Dissection(CESD) for Granular Mixed Nodular Laterally Spreading Tumor in the Rectum (LST-G-M)
A study testing Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventional Endoscopic Submucosal Dissection(ESD) in people with Endoscopic Resection and Rectal Tumor, run by Taihe Hospital.
Trial summary
What is the study about? This study introduces and evaluates a new endoscopic technique called Endoscopic Synchronized Injection and Submucosal Dissection (ESISD). It is designed to remove large, flat precancerous growths in the rectum, known as Granular Mixed Nodular Laterally Spreading Tumors (LST-G-M). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Resection, Rectal Tumor
- What is being tested?
- Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventional Endoscopic Submucosal Dissection(ESD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Endoscopic diagnosis of a large (≥ 20 mm) granular mixed nodular laterally spreading tumor (LST-G-M) located in the rectum.
- Lesion situated 0-15 cm from the anal verge.
- Pre-procedure imaging (e.g., EUS) and endoscopic assessment suggest a very low to low risk of lymph node metastasis (i.e., lesions confined to the mucosa or with superficial submucosal invasion < 1000 μm).
- Deemed suitable for Endoscopic Submucosal Dissection (ESD) based on a comprehensive clinical evaluation by the endoscopist.
- Provision of signed and dated informed consent form.
Who cannot join
- Coagulopathy that cannot be adequately corrected, including an international normalized ratio (INR) > 1.5 or a platelet count < 50,000/μL.
- Evidence of deep submucosal invasion (≥ 1000 μm) or obvious non-lifting sign, suggesting a need for surgical intervention.
- Pregnancy or lactation.
- Inability to tolerate deep sedation or general anesthesia.
- History of colorectal surgery (except for simple appendectomy or polypectomy).
- Presence of a synchronous colorectal cancer that requires priority treatment.
- Recurrent lesions at the same site.
- Any condition that, in the investigator's opinion, could increase the patient's risk or interfere with the study assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
What is the study about? This study introduces and evaluates a new endoscopic technique called Endoscopic Synchronized Injection and Submucosal Dissection (ESISD). It is designed to remove large, flat precancerous growths in the rectum, known as Granular Mixed Nodular Laterally Spreading Tumors (LST-G-M). We compared this new technique to the standard procedure, Conventional Endoscopic Submucosal Dissection (ESD), to see if it is safer, faster, and more efficient.
Who is this for? This research is intended for patients with large, flat rectal polyps, their families seeking the latest treatment options, and healthcare providers interested in advancements in minimally invasive gastroenterology procedures.
- Conditions
- Endoscopic Resection, Rectal Tumor
- Being tested
- Endoscopic Synchronous Injection and Submucosal Dissection(ESISD), Conventional Endoscopic Submucosal Dissection(ESD)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)Procedure or surgery
Also called Conventional Endoscopic Submucosal Dissection
ESISD eliminates the need for injection needles or specialized submucosal agents by integrating injection and dissection into a single procedure. This approach reduces procedural costs, shortens the operation time, and enhances hemostasis during dissection. Additionally, it minimizes electrosurgical carbonization of the knife, preserving its cutting efficacy. The simplicity and broad applicability of ESISD can enhance traditional ESD workflows, warranting further validation across diverse patient populations.
Conventional Endoscopic Submucosal Dissection(ESD)Procedure or surgery
ESD provides a minimally invasive approach for curative treatment of benign, precancerous, and early neoplastic lesions in the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Synchronous Injection and Submucosal Dissection | Experimental | Experimental group Receives: Procedure: Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) |
| Conventional Endoscopic Submucosal Dissection | Active comparator | compare group Receives: Procedure: Conventional Endoscopic Submucosal Dissection(ESD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time
Measured: From enrollment to the end of treatment at 1 day
Hospitalization cost
Measured: From enrollment to the end of treatment at 10 days
Secondary outcomes (2)
The rate of complete resection
Measured: From enrollment to the end of treatment at 1 day
The rate curative resection
Measured: From enrollment to the end of treatment at 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taihe Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236827
- Sponsor's protocol ID
- TaiheH
- Acronym
- ESISD vs CESD
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventional Endoscopic Submucosal Dissection(CESD) for Granular Mixed Nodular Laterally Spreading Tumor in the Rectum (LST-G-M)
- ClinicalTrials.gov ID
- NCT07236827
- Acronym / sponsor ID
- ESISD vs CESD / TaiheH
- Conditions
- Endoscopic Resection, Rectal Tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taihe HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (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.
What is the study about? This study introduces and evaluates a new endoscopic technique called Endoscopic Synchronized Injection and Submucosal Dissection (ESISD). It is designed to remove large, flat precancerous growths in the rectum, known as Granular Mixed Nodular Laterally Spreading Tumors (LST-G-M). We compared this new technique to the standard procedure, Conventional Endoscopic Submucosal Dissection (ESD), to see if it is safer, faster, and more efficient.
Who is this for? This research is intended for patients with large, flat rectal polyps, their families seeking the latest treatment options, and healthcare providers interested in advancements in minimally invasive gastroenterology procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Synchronous Injection and Submucosal Dissection | Experimental | Procedure: Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)Experimental group |
| Conventional Endoscopic Submucosal Dissection | Active comparator | Procedure: Conventional Endoscopic Submucosal Dissection(ESD)compare group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Endoscopic diagnosis of a large (≥ 20 mm) granular mixed nodular laterally spreading tumor (LST-G-M) located in the rectum.
- Lesion situated 0-15 cm from the anal verge.
- Pre-procedure imaging (e.g., EUS) and endoscopic assessment suggest a very low to low risk of lymph node metastasis (i.e., lesions confined to the mucosa or with superficial submucosal invasion < 1000 μm).
- Deemed suitable for Endoscopic Submucosal Dissection (ESD) based on a comprehensive clinical evaluation by the endoscopist.
Key exclusion criteria (8 listed)
- Coagulopathy that cannot be adequately corrected, including an international normalized ratio (INR) > 1.5 or a platelet count < 50,000/μL.
- Evidence of deep submucosal invasion (≥ 1000 μm) or obvious non-lifting sign, suggesting a need for surgical intervention.
- Pregnancy or lactation.
- Inability to tolerate deep sedation or general anesthesia.
- History of colorectal surgery (except for simple appendectomy or polypectomy).
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 |
|---|---|---|
| Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)Also: Conventional Endoscopic Submucosal DissectionESISD eliminates the need for injection needles or specialized submucosal agents by integrating injection and dissection into a single procedure. This approach reduces procedural costs, shortens the operation time, and enhances hemostasis during dissection. Additionally, it minimizes electrosurgical carbonization of the knife, preserving its cutting efficacy. The simplicity and broad applicability of ESISD can enhance traditional ESD workflows, warranting further validation across diverse patient populations. | Procedure or surgery | Endoscopic Synchronous Injection and Submucosal Dissection |
| Conventional Endoscopic Submucosal Dissection(ESD)ESD provides a minimally invasive approach for curative treatment of benign, precancerous, and early neoplastic lesions in the gastrointestinal tract | Procedure or surgery | Conventional Endoscopic Submucosal Dissection |
Primary outcome
procedure time
Time frame: From enrollment to the end of treatment at 1 day
Hospitalization cost
Time frame: From enrollment to the end of treatment at 10 days
2 secondary outcomes
The rate of complete resection
Time frame: From enrollment to the end of treatment at 1 day
The rate curative resection
Time frame: From enrollment to the end of treatment at 10 days
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventional Endoscopic Submucosal Dissection(ESD) in people with Endoscopic Resection and Rectal Tumor, run by Taihe Hospital.
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 8 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: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yuanjun Gao (8801755, liuxb1818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure time (time frame: From enrollment to the end of treatment at 1 day). The study lists 2 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 19 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.