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)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaihe Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic Synchronous Injection and Submucosal Dissection(ESISD)

    Procedure/Surgery

    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(ESD)

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Endoscopic Synchronous Injection and Submucosal DissectionExperimental treatment 1 intervention
Group B: Conventional Endoscopic Submucosal DissectionActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: