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

Study Overview
=================
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.

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

Conditions
-----------------
Rectal Neuroendocrine Tumor

Intervention / Treatment
-----------------
* Procedure: ESD procedure
* Procedure: EMR-C procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESD group<br>In ESD group, enrolled patients will receive the treatment modality of ESD to remove the rectal NET | Procedure: ESD procedure<br>* 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.<br>|
| Experimental: EMR-C group<br>In EMR-C group, enrolled patients will receive the treatment modality of EMR-C to remove the rectal NET | Procedure: EMR-C procedure<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection rate(R0 rate) | Complete resection was defined as negative horizontal and vertical margins of specimen. | within 14 days after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time | the time from endoscope in to endoscope out | intraoperative | 
| complications rate | Complications were defined as perforation or hemorrhage during or after operation. | within 14 days after procedure | 
| length of stay | calculated from the day of admission to day of discharge | within 14 days after procedure | 
| hospitalization cost | represent the hospital's costs of being hospitalized | within 14 days after procedure | 
| recurrence rate | a new rectal NET recurred confirmed by endoscopy and EUS | one year after procedure |