Endoscopic Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

NCT03982264 | Unknown

• 1 other identifier: NFEC-2017-077
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cap-assisted endoscopic mucosal resection (EMR-C) and endoscopic submucosal dissection (ESD) have both been reported to be effective treatment methods for small rectal neuroendocrine tumor (NET) in limited studies. Which one is better has not been determined. We aimed to compare the efficacy and safety of EMR-C and ESD for the treatment of small rectal NET.

Conditions

Rectal Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• complete resection rate(R0 rate)

  Complete resection was defined as negative horizontal and vertical margins of specimen.

  within 14 days after procedure

Secondary Outcomes (5)

• operating time

  intraoperative

• complications rate

  within 14 days after procedure

• length of stay

  within 14 days after procedure

• hospitalization cost

  within 14 days after procedure

• recurrence rate

  one year after procedure

Study Arms (2)

ESD group

ACTIVE COMPARATOR

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

Procedure: ESD procedure

EMR-C group

EXPERIMENTAL

In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET

Procedure: EMR-C procedure

Interventions

ESD procedure PROCEDURE

ESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding.

ESD group

EMR-C procedure PROCEDURE

A transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding.

EMR-C 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;
• Definite diagnosis of rectal NET less than 10mm;
• Patients plan to receive either EMR-C or ESD treatment.

You may not qualify if:

• Serious comorbid diseases such as advanced malignant tumor and organ failure;
• Patients received conventional EMR, snare electrotomy and no treatment;
• Rectal NET with metastasis;
• Pregnant patient;
• Poor compliance

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Related Publications (1)

• Gao X, Huang S, Wang Y, Peng Q, Li W, Zou Y, Han Z, Cai J, Luo Y, Ye Y, Li A, Bai Y, Chen Y, Liu S, Li Y. Modified Cap-Assisted Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Rectal Neuroendocrine Tumors </=10 mm: A Randomized Noninferiority Trial. Am J Gastroenterol. 2022 Dec 1;117(12):1982-1989. doi: 10.14309/ajg.0000000000001914. Epub 2022 Aug 23.

  PMID: 36455222 DERIVED

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 5, 2019
• First Posted: June 11, 2019
• Study Start: June 20, 2019
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2021
• Last Updated: June 11, 2019

Record last verified: 2019-06