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

NCT ID: NCT03982264

Last Updated: 2019-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2021-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESD group

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

Group Type: ACTIVE_COMPARATOR

ESD procedure

Intervention Type: 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.

EMR-C group

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

Group Type: EXPERIMENTAL

EMR-C procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 36455222 (View on PubMed)

Other Identifiers

NFEC-2017-077

Identifier Type: -

Identifier Source: org_study_id