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)

NCT ID: NCT07236827

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endoscopic Synchronous Injection and Submucosal Dissection

Experimental group

Group Type: EXPERIMENTAL

Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)

Intervention Type: 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.

Conventional Endoscopic Submucosal Dissection

compare group

Group Type: ACTIVE_COMPARATOR

Conventional Endoscopic Submucosal Dissection(ESD)

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Conventional Endoscopic Submucosal Dissection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taihe Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yuanjun Gao

Role: CONTACT

liuxb1818@163.com

8801755

Other Identifiers

TaiheH

Identifier Type: -

Identifier Source: org_study_id