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)

NCT07236827 | Not Yet Recruiting

• 1 other identifier: TaiheH
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Endoscopic Resection; Rectal Tumor

Outcome Measures

Primary Outcomes (2)

• procedure time

  From enrollment to the end of treatment at 1 day

• Hospitalization cost

  From enrollment to the end of treatment at 10 days

Secondary Outcomes (2)

• The rate of complete resection

  From enrollment to the end of treatment at 1 day

• The rate curative resection

  From enrollment to the end of treatment at 10 days

Study Arms (2)

Endoscopic Synchronous Injection and Submucosal Dissection

EXPERIMENTAL

Experimental group

Procedure: Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)

Conventional Endoscopic Submucosal Dissection

ACTIVE COMPARATOR

compare group

Procedure: Conventional Endoscopic Submucosal Dissection(ESD)

Interventions

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.

Also known as: Conventional Endoscopic Submucosal Dissection

Endoscopic Synchronous Injection and 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

Conventional Endoscopic Submucosal Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taihe Hospital: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yuanjun Gao

CONTACT

8801755; liuxb1818@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11