Endoscopic Resection for Small Rectal Neuroendocrine Tumors

NCT06901856 | Not Yet Recruiting

• 1 other identifier: KY2025-063-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.

Conditions

Rectal Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• histological complete resection

  complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.

  within 14 days after procedure

Secondary Outcomes (8)

• success rate of operation

  intraoperative

• en bloc resection

  intraoperative

• operation time

  intraoperative

• complications

  within 14 days after procedure

• length of stay

  within 14 days after procedure

Study Arms (2)

mEMR-C group

EXPERIMENTAL

In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.

Procedure: mEMR-C procedure

mEMR-L group

ACTIVE COMPARATOR

In mEMR-L group, enrolled patients will receive modified ESMR-L without submucosal injection.

Procedure: mEMR-L procedure

Interventions

mEMR-C procedure PROCEDURE

A transparent cap with an inner groove (MH-593; Olympus, Tokyo, Japan) was attached to the forward-viewing colonoscope. After the endoscope was inserted into the rectum, a crescent-shaped electrosurgical snare was passed through the sheath and looped along the inner groove of the cap. Submucosal injections were not required in this method. The tumor was suctioned into the cap and grasped by tightening the snare. After confirming the appropriate snare placement, both the tumor and overlying mucosa were resected using electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and the resected tumor was sent for pathological examination. Endoscopic examination was repeated without a transparent cap to evaluate the wound carefully in cases of perforation or bleeding and to ensure the absence of residual tumor tissues. If there was spurting or active bleeding, hot forceps were used to stop the bleeding.

mEMR-C group

mEMR-L procedure PROCEDURE

First, install the ligation device (provided by Jiangsu Gerrit) at the front end of the endoscope. After inserting the endoscope into the rectum, suck the lesion into the ligation device, release the ligator to ligate the lesion. Then, use a snare to resect the lesion below the ligator. Finally, uniformly suture the wound surface with metal clips.

mEMR-L group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 80 years;
• With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
• With tumor size ≤10 mm assessed by colonoscopy;
• Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;

You may not qualify if:

• Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;
• Rectal NET with lymph node metastasis or distant metastasis;
• Received resection of rectal neuroendocrine tumor by other surgical procedures;
• Multiple rectal neuroendocrine tumors;
• Vulnerable groups such as pregnant women or patients with mental disorders;
• Poor compliance, unable to cooperate with treatment.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03