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

Cap Endoscopic Mucosal Resection(EMR-C) Versus Endoscopic Submucosal Dissection(ESD) for Treatment of Rectal Neuroendocrine Tumor(NET) Less Than 10mm

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Neuroendocrine Tumor
• Intervention / Treatment: Procedure: ESD procedure; Procedure: EMR-C procedure

• Study Type: Interventional
• Enrollment (Anticipated): 90
• 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:

• Age from 18 to 75 years;
• Definite diagnosis of rectal NET less than 10mm;
• Patients plan to receive either EMR-C or ESD treatment.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ESD group; In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET	Procedure: ESD 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.
EXPERIMENTAL: EMR-C group; In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET	Procedure: EMR-C 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete resection rate(R0 rate)	Complete resection was defined as negative horizontal and vertical margins of specimen.	within 14 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	the time from endoscope in to endoscope out	intraoperative
complications rate	Complications were defined as perforation or hemorrhage during or after operation.	within 14 days after procedure
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
recurrence rate	a new rectal NET recurred confirmed by endoscopy and EUS	one year after procedure

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 20, 2019
• Primary Completion (ANTICIPATED): December 20, 2020
• Study Completion (ANTICIPATED): December 20, 2021

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (ACTUAL): June 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

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-2017-077

Drug and device information, study documents

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