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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Rectal Neuroendocrine Tumor

Treatments: Procedure: EMR-C procedure; Procedure: ESD procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03982264

NFEC-2017-077

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

ESD group

Active Comparator group

Description:

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

Treatment:

Procedure: ESD procedure

EMR-C group

Experimental group

Description:

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

Treatment:

Procedure: EMR-C procedure