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

Rectal Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03982264
• Other study ID #: NFEC-2017-077
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: June 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors
• Rectal Neuroendocrine Tumor

Intervention

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.
• 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.

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	complete resection rate(R0 rate)	Complete resection was defined as negative horizontal and vertical margins of specimen.	within 14 days after procedure
Secondary	operating time	the time from endoscope in to endoscope out	intraoperative
Secondary	complications rate	Complications were defined as 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	recurrence rate	a new rectal NET recurred confirmed by endoscopy and EUS	one year after procedure