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) (ESISD vs CESD)
November 14, 2025 updated by: Taihe Hospital
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuanjun Gao
- Phone Number: 8801755
- Email: liuxb1818@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Endoscopic Synchronous Injection and Submucosal Dissection
Experimental group
|
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.
Other Names:
|
|
Active Comparator: Conventional Endoscopic Submucosal Dissection
compare group
|
ESD provides a minimally invasive approach for curative treatment of benign, precancerous, and early neoplastic lesions in the gastrointestinal tract
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
procedure time
Time Frame: From enrollment to the end of treatment at 1 day
|
From enrollment to the end of treatment at 1 day
|
|
Hospitalization cost
Time Frame: From enrollment to the end of treatment at 10 days
|
From enrollment to the end of treatment at 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The rate of complete resection
Time Frame: From enrollment to the end of treatment at 1 day
|
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
|
From enrollment to the end of treatment at 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 14, 2025
First Submitted That Met QC Criteria
November 14, 2025
First Posted (Actual)
November 19, 2025
Study Record Updates
Last Update Posted (Actual)
November 19, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TaiheH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.