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NCT Number: NCT07612748

Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

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.

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Key information

Conditions

Rectal Neuroendocrine Tumors EPMR ESD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Hospital of Jilin University, Changchun, Jilin, China

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About this study

The investigators compared 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 EID 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. Through this comparative analysis, The investigators would identify the optimal endoscopic technique for treating rectal neuroendocrine tumors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoscopic intermuscular dissection (EID)

Procedure

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)

Procedure

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.

Primary outcomes

  1. the positive margin rate

    Time frame: 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.

Secondary outcomes

  1. Number of rectal neuroendocrine neoplasm lesions.

    Time frame: One week after the endoscopic treatment

    The number of rectal neuroendocrine neoplasm lesions per case.

Other outcomes

  1. Maximum lesion diameter.

    Time frame: one week after the endoscopic treatment

    The longest diameter of each lesion was measured endoscopically and recorded in centimeters.

  2. Operation time per single lesion.

    Time frame: One week after the endoscopic dissection

    The procedure time for each lesion was measured from the start of dissection to completion, expressed in minutes.

  3. Complications (including bleeding and perforation).

    Time frame: One week after the endoscopic dissection

    All complications were recorded including bleeding and perforation.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Yang, Doctor

CONTACT

[email protected]

86-18844097668

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

Retrospective Comparative Study of Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 29, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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