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Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07612748
Enrollment
483
Registered
2026-05-29
Start date
2026-06-01
Completion date
2027-12-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EPMR, ESD, Rectal Neuroendocrine Tumors

Keywords

ESD, EPMR

Brief 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.

Detailed description

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.

Interventions

PROCEDUREendoscopic 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.

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.

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
the positive margin rateOne week after the endoscopic treatmentA 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

MeasureTime frameDescription
Number of rectal neuroendocrine neoplasm lesions.One week after the endoscopic treatmentThe number of rectal neuroendocrine neoplasm lesions per case.

Countries

China

Contacts

CONTACTDong Yang, Doctor
yang_dong@jlu.edu.cn86-18844097668

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026