Endoscopic Resection for Small Rectal Neuroendocrine Tumors

NCT ID: NCT06901856

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-10-31

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.

Detailed Description

We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.

Conditions

Rectal Neuroendocrine Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mEMR-C group

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

Group Type: EXPERIMENTAL

mEMR-C procedure

Intervention Type: 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-L group

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

Group Type: ACTIVE_COMPARATOR

mEMR-L procedure

Intervention Type: 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.

Interventions

mEMR-C 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.

Intervention Type: PROCEDURE

mEMR-L 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age from 18 to 80 years;

2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;

3. With tumor size ≤10 mm assessed by colonoscopy;

4. Plan to receive mEMR-C or mEMR-L treatment and provide written informed consent;

Exclusion Criteria

1. Unable to tolerate mEMR-L or mEMR-C as assessed by the research team of each center;

2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;

3. Rectal NET with lymph node metastasis or distant metastasis;

4. Received resection of rectal neuroendocrine tumor by other surgical procedures;

5. Multiple rectal neuroendocrine tumors;

6. Vulnerable groups such as pregnant women or patients with mental disorders;

7. Poor compliance, unable to cooperate with treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KY2025-063-02

Identifier Type: -

Identifier Source: org_study_id