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NCT Number: NCT05429216

Endoscopic Resection for Small Rectal Neuroendocrine Tumors

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.

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Key information

Conditions

Rectal Neuroendocrine Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
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;
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.

Treatment and study plan

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.

ESD procedure

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.

Primary outcomes

histological complete resection

Time frame: within 14 days after procedure

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

Secondary outcomes

success rate of operation

Time frame: intraoperative

the proportion of patients whose tumors were successfully resected in each group
en bloc resection

Time frame: intraoperative

complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
operation time

Time frame: intraoperative

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
complications

Time frame: within 14 days after procedure

perforation or hemorrhage during or after operation.
length of stay

Time frame: within 14 days after procedure

calculated from the day of admission to day of discharge
hospitalization cost

Time frame: within 14 days after procedure

represent the hospital's costs of being hospitalized
operation cost

Time frame: within 14 days after procedure

the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures
histopathologic grade

Time frame: within 14 days after procedure

NET grade 1, NET grade 2, NET grade 3, and NEC

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2026
First posted: Jun 23, 2022
Registry last updated: Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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