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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03982264

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neuroendocrine Tumor	Procedure: ESD procedure Procedure: EMR-C procedure	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 20, 2019

Anticipated Primary Completion Date :

Dec 20, 2020

Anticipated Study Completion Date :

Dec 20, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

complete resection rate(R0 rate) [within 14 days after procedure]
Complete resection was defined as negative horizontal and vertical margins of specimen.

Secondary Outcome Measures

operating time [intraoperative]
the time from endoscope in to endoscope out
complications rate [within 14 days after procedure]
Complications were defined as perforation or hemorrhage during or after operation.
length of stay [within 14 days after procedure]
calculated from the day of admission to day of discharge
hospitalization cost [within 14 days after procedure]
represent the hospital's costs of being hospitalized
recurrence rate [one year after procedure]
a new rectal NET recurred confirmed by endoscopy and EUS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03982264

Other Study ID Numbers:

NFEC-2017-077

First Posted:

Jun 11, 2019

Last Update Posted:

Jun 11, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Study Results

No Results Posted as of Jun 11, 2019