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UnknownNCT03982264

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREESD procedureESD 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.
PROCEDUREEMR-C procedureA 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.

Timeline

Start date
2019-06-20
Primary completion
2020-12-20
Completion
2021-12-20
First posted
2019-06-11
Last updated
2019-06-11

Source: ClinicalTrials.gov record NCT03982264. Inclusion in this directory is not an endorsement.