A Comparison of Endoscopic Synchronous Injection and Submucosal Dissection(ESISD) and Conventiona… (NCT07236827) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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)
60 participantsStarted 2025-12-01
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
procedure time
Timeframe: From enrollment to the end of treatment at 1 day
2
Hospitalization cost
Timeframe: From enrollment to the end of treatment at 10 days