Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Rectal Neuroendocrine Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05429216
• Other study ID #: NFEC-2022-206
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Rectal Neuroendocrine Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	success rate of operation	the proportion of patients whose tumors were successfully resected in each group	intraoperative
Secondary	en bloc resection	complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined	intraoperative
Secondary	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
Secondary	complications	perforation or hemorrhage during or after operation.	within 14 days after procedure
Secondary	length of stay	calculated from the day of admission to day of discharge	within 14 days after procedure
Secondary	hospitalization cost	represent the hospital's costs of being hospitalized	within 14 days after procedure
Secondary	operation cost	the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures	within 14 days after procedure
Secondary	histopathologic grade	NET grade 1, NET grade 2, NET grade 3, and NEC	within 14 days after procedure