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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03982264
Enrollment
90
Registered
2019-06-11
Start date
2019-06-20
Completion date
2021-12-20
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neuroendocrine Tumor

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.

Interventions

PROCEDUREESD 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.

PROCEDUREEMR-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.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complete resection rate(R0 rate)within 14 days after procedureComplete resection was defined as negative horizontal and vertical margins of specimen.

Secondary

MeasureTime frameDescription
operating timeintraoperativethe time from endoscope in to endoscope out
complications ratewithin 14 days after procedureComplications were defined as perforation or hemorrhage during or after operation.
length of staywithin 14 days after procedurecalculated from the day of admission to day of discharge
hospitalization costwithin 14 days after procedurerepresent the hospital's costs of being hospitalized
recurrence rateone year after procedurea new rectal NET recurred confirmed by endoscopy and EUS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026