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

Not Applicable

• Conditions: Rectal Neuroendocrine Tumor
• Interventions: Procedure: ESD procedure; Procedure: EMR-C procedure

• Registration Number: NCT03982264
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Study First Posted: 2019-06-11
• Last Update Posted: 2019-06-11
• Study Start: 2019-06-20
• Primary Completion: 2020-12-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESD group	ESD procedure	In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET
EMR-C group	EMR-C procedure	In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
operating time	intraoperative	the time from endoscope in to endoscope out
hospitalization cost	within 14 days after procedure	represent the hospital's costs of being hospitalized
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
recurrence rate	one year after procedure	a new rectal NET recurred confirmed by endoscopy and EUS