What is the study about? This study introduces and evaluates a new endoscopic techniquecalled Endoscopic Synchronized Injection and Submucosal Dissection (ESISD). It isdesigned to remove large, flat precancerous growths in the rectum, known as GranularMixed Nodular Laterally Spreading Tumors (LST-G-M). We compared this new technique to thestandard procedure, Conventional Endoscopic Submucosal Dissection (ESD), to see if it issafer, 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 interestedin advancements in minimally invasive gastroenterology procedures.
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Procedure: Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)
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 Name: Conventional Endoscopic Submucosal Dissection
Procedure: 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
Inclusion Criteria:
1. Age ≥ 18 years.
2. Endoscopic diagnosis of a large (≥ 20 mm) granular mixed nodular laterally spreading
tumor (LST-G-M) located in the rectum.
3. Lesion situated 0-15 cm from the anal verge.
4. 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).
5. Deemed suitable for Endoscopic Submucosal Dissection (ESD) based on a comprehensive
clinical evaluation by the endoscopist.
6. Provision of signed and dated informed consent form.
Exclusion Criteria:
1. Coagulopathy that cannot be adequately corrected, including an international
normalized ratio (INR) > 1.5 or a platelet count < 50,000/μL.
2. Evidence of deep submucosal invasion (≥ 1000 μm) or obvious non-lifting sign,
suggesting a need for surgical intervention.
3. Pregnancy or lactation.
4. Inability to tolerate deep sedation or general anesthesia.
5. History of colorectal surgery (except for simple appendectomy or polypectomy).
6. Presence of a synchronous colorectal cancer that requires priority treatment.
7. Recurrent lesions at the same site.
8. Any condition that, in the investigator's opinion, could increase the patient's risk
or interfere with the study assessments.
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Yuanjun Gao
8801755
liuxb1818@163.com
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