Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial

In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neuroendocrine Tumor
• Intervention / Treatment: Procedure: mEMR-C procedure; Procedure: ESD procedure

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 102
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age from 18 to 75 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 ESD treatment and provide written informed consent;

Exclusion Criteria:

1. Unable to tolerate ESD 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mEMR-C group; In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.	Procedure: 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.
Active Comparator: ESD group; In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET	Procedure: ESD procedure; ESD was performed as the standard procedure and has been widely described and used. First, dots were marked approximately 5 mm from the periphery of the lesion using coagulation. Subsequently, a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. Mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan). After resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	calculated from the day of admission to day of discharge	within 14 days after procedure
hospitalization cost	represent the hospital's costs of being hospitalized	within 14 days after procedure
success rate of operation	the proportion of patients whose tumors were successfully resected in each group	intraoperative
en bloc resection	complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined	intraoperative
operation time	the time required to complete the procedure, was taken from the installation of the snare in the mEMR-C or the first submucosal injection in ESD to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation	intraoperative
complications	perforation or hemorrhage during or after operation.	within 14 days after procedure
operation cost	the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures	within 14 days after procedure
histopathologic grade	NET grade 1, NET grade 2, NET grade 3, and NEC	within 14 days after procedure

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: NFEC-2022-206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No