About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)
- Conventional Endoscopic Submucosal Dissection(ESD)