Endoscopic Resection for Small Rectal Neuroendocrine Tumors

NCT05429216 | Not Yet Recruiting

• 1 other identifier: NFEC-2022-206
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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

ESD group

ACTIVE COMPARATOR

In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET

Procedure: ESD 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

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.

ESD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Unable to tolerate ESD 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

• Nanfang Hospital, Southern Medical University: 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: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 1, 2022

Record last verified: 2022-05