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Recruiting Not applicable

Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

NCT07612748 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-06-01
Last updated
2026-06-03

Condition(s) studied

Rectal Neuroendocrine TumorsESDEPMR

Investigational drug(s) / intervention(s)

endoscopic intermuscular dissection (EID)Endoscopic Submucosal Dissection (ESD)

endoscopic intermuscular dissection (EID): EID:Endoscopic Intermuscular Dissection (EID) is an ultra-minimally invasive technique derived from conventional Endoscopic Submucosal Dissection (ESD). Its core principle is not merely to dissect within the submucosal layer, but to "deepen" the dissection plane into the muscularis propria of the rectal wall. Specifically, the surgeon utilizes the natural anatomical plane between the inner circular muscle and the outer longitudinal muscle layers for precise dissection. This procedure involves resecting part of the affected inner circular muscle while preserving the integrity of the outer longitudinal muscle layer.

Endoscopic Submucosal Dissection (ESD): ESD: A solution is injected beneath the mucosa to create a submucosal cushion, followed by the use of specialized electrosurgical knives to dissect directly within the submucosal layer, thereby achieving en bloc resection of the tumor.

Study summary

The aim is to compare the safety and efficacy of endoscopic submucosal dissection (ESD) versus endoscopic partial muscle resection( EPMR) for the treatment of rectal neuroendocrine neoplasms (R-NENs), thereby providing guidance for optimizing therapeutic strategies. The investigators retrospectively analyzed consecutive patients with R-NENs who underwent endoscopic resection at our center between January 2020 and February 2026. Patients were assigned to either the ESD group or the EPMR group. Baseline characteristics and perioperative outcomes were compared, including the number of lesions, maximum lesion diameter, single-lesion procedure time, postoperative complications, positive margin rate, pathological staging, lymphovascular invasion, and the need for additional therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing endoscopic treatment for rectal neuroendocrine neoplasms. * Lesion diameter less than 2 cm. * Preoperative auxiliary examinations indicating no peripheral lymph node or distant metastasis. * Endoscopic surgical approach limited to ESD or EPMR. Exclusion Criteria: * Use of non-ESD or non-EPMR endoscopic techniques, such as ligation-assisted resection or Endoscopic Mucosal Resection (EMR). * Presence of other conditions deemed by the investigator to be unsuitable for participation in this study. * Patient or family refusal to participate.

Primary outcome measure(s)

  • the positive margin rate — One week after the endoscopic treatment
    A positive margin indicates that cancer cells extend to the edge of the removed specimen, suggesting that residual tumor may remain in situ. The positive margin rate is calculated as the number of cases with positive margins divided by the total number of resected cases, expressed as a percentage. It serves as a critical quality indicator for the completeness of tumor removal.

Trial sites (2)

FacilityCityRegionStatus
the First Hospital of Jilin University Changchun Jilin Recruiting
the First Hospital of Jilin University Changchun China Active Not Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612748 on ClinicalTrials.gov ↗ ← All trials in China