NCT07236827Not yet recruiting
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)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Taihe Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07236827
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Dec 2025 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of deep submucosal invasion (≥ 1000 μm) or obvious non-lifting sign, suggesting a need for surgical intervention.
Other illness
- History of colorectal surgery (except for simple appendectomy or polypectomy).
- Presence of a synchronous colorectal cancer that requires priority treatment.
- Any condition that, in the investigator's opinion, could increase the patient's risk or interfere with the study assessments.
Lab values
- Coagulopathy that cannot be adequately corrected, including an international normalized ratio (INR) \> 1.5 or a platelet count \< 50,000/μL.
Other
- Pregnancy or lactation.
- Inability to tolerate deep sedation or general anesthesia.
- Recurrent lesions at the same site.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.