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) (ESISD vs CESD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Tumor; Endoscopic Resection
• Intervention / Treatment: Procedure: Endoscopic Synchronous Injection and Submucosal Dissection(ESISD); Procedure: Conventional Endoscopic Submucosal Dissection(ESD)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanjun Gao; Phone Number: 8801755; Email: liuxb1818@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic Synchronous Injection and Submucosal Dissection; Experimental group	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 Names: Conventional Endoscopic Submucosal Dissection
Active Comparator: Conventional Endoscopic Submucosal Dissection; compare group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Taihe Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: TaiheH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No