Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.

Detailed Description
-----------------
Generally, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the methods of choice for the removal of benign and early malignant neoplasms of the colon. However, there are certain difficulties in terms of the EMR technique - this is an increase in the frequency of fragmentation with a lesion size of more than 20 mm, which in turn increases the risk of recurrence; with regard to ESD technique, this is a long procedure time; high incidence of complications; significant time required for teaching the technique; technical difficulties. In this regard, it is worth paying attention to the method of endoscopic mucosal resection with circumferential mucosal incision (C-EMR). This method deserves interest due to the fact that it allows more often to perform en-block resections in comparison with the classical method of endoscopic mucosal resection (EMR - endoscopic mucosal resection); technically easier to do; takes a short procedure time.

Official Title
-----------------
Treament for Colorectal Neoplasms by Metod Endoscopic Mucosal Resection With Circumferential Mucosal Incision

Conditions
-----------------
Endoscopic Mucosal Resection With Circumferential Incision

Intervention / Treatment
-----------------
* Procedure: Endoscopic mucosal resection with circumferential incision
* Procedure: Endoscopic submucosal dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with benign colon neoplasms without signs of deep invasion (I, II, IIIL and IV type according to Kudo, I and II type according to Sano) the size of the neoplasm is from 20 mm to 30 mm patient for treatment Exclusion Criteria: unsatisfactory tumor lifting refusal of the patient from research at any stage of treatment

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, single-center, randomized, non inferiority
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic mucosal resection with circumferential incision<br>The endoscope will be passed into the intestine to the site of the tumor. Then, using an endoscopic needle, a solution will be injected into the submucosa to remove the neoplasm. Using an endoscopic knife (insulated tip knife, Olympus or Water Jet, Erbe), a circular incision will be made around the lesion. Then there will be a one-stage electro excision of the neoplasm using an endoscopic loop. | Procedure: Endoscopic mucosal resection with circumferential incision<br>* The endoscope will be passed into the intestine to the site of the tumor. Using an endoscopic needle, the solution will be injected into the submucosa to create a pillow. Then, using an endoscopic knife (insulated tip knife, Olympus or Water Jet, Erbe), a circular incision will be made around the lesion with an offset of 2-5 mm. Then there will be a one-stage electro excision of the neoplasm using an endoscopic loop.<br>|
| Active Comparator: endoscopic submucosal dissection<br>The endoscope will be passed into the intestine to the site of the tumor. Then, using an endoscopic needle, a solution will be injected into the submucosa to remove the neoplasm. Using an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe), the lesion will be resected through the submucosal plane using the eb-block principle, after which the patient will be monitored. | Procedure: Endoscopic submucosal dissection<br>* The endoscope will be passed into the intestine to the site of the tumor. Using an endoscopic needle, the solution will be injected into the submucosa to create a pillow. Then, using an endoscopic knife (insulated tip knife, Olympus or Water Jet, Erbe), a circular incision is made around the lesion. Then dissection will be performed in the submucosal layer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate |  | 14 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En-block resesction rate |  | 14 day | 
| conversion rate |  | 1 day | 
| intervention time |  | 1 day | 
| intra- and postoperative complications rate |  | 30 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic treatment, colorectal neoplasm, circumferential incision, C-EMR