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NCT Number: NCT07236827

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)

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)

Procedure

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: Conventional Endoscopic Submucosal Dissection

Conventional Endoscopic Submucosal Dissection(ESD)

Procedure

ESD provides a minimally invasive approach for curative treatment of benign, precancerous, and early neoplastic lesions in the gastrointestinal tract

Primary outcomes

  1. procedure time

    Time frame: From enrollment to the end of treatment at 1 day

  2. Hospitalization cost

    Time frame: From enrollment to the end of treatment at 10 days

Secondary outcomes

  1. The rate of complete resection

    Time frame: From enrollment to the end of treatment at 1 day

  2. The rate curative resection

    Time frame: From enrollment to the end of treatment at 10 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yuanjun Gao

CONTACT

[email protected]

8801755

Sponsors and collaborators

Lead sponsor

Taihe Hospital

Other

Registry information

Acronym: ESISD vs CESD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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