Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJilin University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
endoscopic intermuscular dissection (EID)
Procedure/SurgeryEID：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/SurgeryESD: 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.
Treatment groups
483 Participants
are divided into 2 treatment groupsGroup A: ESD groupActive comparator 1 intervention
Group B: EID groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the positive margin rate
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.
Time frame
One week after the endoscopic treatmentSecondary outcomes
1
Number of rectal neuroendocrine neoplasm lesions.
The number of rectal neuroendocrine neoplasm lesions per case.
Time frame
One week after the endoscopic treatmentOther outcomes
1
Maximum lesion diameter.
The longest diameter of each lesion was measured endoscopically and recorded in centimeters.
Time frame
one week after the endoscopic treatment2
Operation time per single lesion.
The procedure time for each lesion was measured from the start of dissection to completion, expressed in minutes.
Time frame
One week after the endoscopic dissection3
Complications (including bleeding and perforation).
All complications were recorded including bleeding and perforation.
Time frame
One week after the endoscopic dissectionSponsors and contacts
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Source ClinicalTrials.gov