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RecruitingNCT07612748Updated Jun 3, 2026

Two Different Endoscopic Treatments for Rectal Neuroendocrine Neoplasms

An interventional study of endoscopic intermuscular dissection (EID) and Endoscopic Submucosal Dissection (ESD) in Rectal Neuroendocrine Tumors, ESD and EPMR, sponsored by Jilin University. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Jilin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
483
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Rectal Neuroendocrine Tumors
  • ESD
  • EPMR

Keywords

  • ESD
  • EPMR
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
483 participants (estimated)

Study arms

  • Active comparator
    ESD group

    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)

  • Experimental
    EID group

    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

  • 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.

  • ProcedureEndoscopic 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.

05

What researchers measure

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 treatment

Secondary outcomes

  1. Number of rectal neuroendocrine neoplasm lesions.

    The number of rectal neuroendocrine neoplasm lesions per case.

    Time frame: One week after the endoscopic treatment

Other 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 treatment

  2. 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 dissection

  3. Complications (including bleeding and perforation).

    All complications were recorded including bleeding and perforation.

    Time frame: One week after the endoscopic dissection

06

Study locations

1 of 2 sites recruiting
  • the First Hospital of Jilin University
    Changchun, Jilin 130021, China
    Recruiting
  • the First Hospital of Jilin University
    Changchun, 130021, China
    Active, not recruiting
07

References and documents

Publications

  • 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. PubMed 38428913 ↗
  • 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. PubMed 37604447 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07612748
Lead sponsor
Jilin University
Responsible party
Dong Yang (Doctor, Jilin University) — Principal investigator
First posted
May 29, 2026
Start date
Jun 1, 2026
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Dong Yang, Doctor
Contact
yang_dong@jlu.edu.cn
86-18844097668

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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