Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

NCT07612748 | Recruiting DMC

• 1 other identifier: 130023
• Study Type: interventional
• Target: 483
• Locations: 1 country
• Sites: 2

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.

Conditions

EPMR; Rectal Neuroendocrine Tumors; ESD

Keywords

ESD; EPMR

Outcome Measures

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.

  One week after the endoscopic treatment

Secondary Outcomes (1)

• Number of rectal neuroendocrine neoplasm lesions.

  One week after the endoscopic treatment

Other Outcomes (3)

• Maximum lesion diameter.

  one week after the endoscopic treatment

• Operation time per single lesion.

  One week after the endoscopic dissection

• Complications (including bleeding and perforation).

  One week after the endoscopic dissection

Study Arms (2)

ESD group

ACTIVE COMPARATOR

The ESD group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic submucosal dissection (ESD).

Procedure: Endoscopic Submucosal Dissection (ESD)

EID group

EXPERIMENTAL

The EPMR group would enroll cases undergoing endoscopic treatment for rectal neuroendocrine neoplasms, and the treatment method of all cases in this group should be endoscopic partial muscle resection ( EPMR).

Procedure: endoscopic intermuscular dissection (EID)

Interventions

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.

EID group

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.

ESD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (2)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

the First Hospital of Jilin University

Changchun, 130021, China

ACTIVE NOT RECRUITING

Related Publications (2)

• De Cristofaro E, Rivory J, Masgnaux LJ, Wallenhorst T, Jacques J, Lafeuille P, Pioche M. Repeat endoscopic intermuscular dissection of the visible scar after noncurative endoscopic intermuscular dissection of a rectal neuroendocrine tumor. Endoscopy. 2024 Dec;56(S 01):E205-E206. doi: 10.1055/a-2261-7919. Epub 2024 Mar 1. No abstract available.

  PMID: 38428913 RESULT

• Liao S, Li B, Huang L, Qiu Q, Yang G, Ren J, Huang S. Endoscopic intermuscular dissection in the management of a rectal neuroendocrine tumor. Endoscopy. 2023 Dec;55(S 01):E977-E979. doi: 10.1055/a-2139-4310. Epub 2023 Aug 21. No abstract available.

  PMID: 37604447 RESULT

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Dong Yang, Doctor

CONTACT

86-18844097668; yang_dong@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (2)