C-EMR: Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

Sponsor

State Scientific Centre of Coloproctology, Russian Federation (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05690490

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Mucosal Resection With Circumferential Incision	Procedure: Endoscopic mucosal resection with circumferential incision Procedure: Endoscopic submucosal dissection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective, single-center, randomized, non inferiorityprospective, single-center, randomized, non inferiority

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 27, 2020

Anticipated Primary Completion Date :

Sep 27, 2023

Anticipated Study Completion Date :

Nov 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endoscopic mucosal resection with circumferential incision 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 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.
Active Comparator: endoscopic submucosal dissection 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 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.

Arm

Intervention/Treatment

Experimental: endoscopic mucosal resection with circumferential incision

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

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.

Active Comparator: endoscopic submucosal dissection

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

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.

Outcome Measures

Primary Outcome Measures

R0 resection rate [14 day]

Secondary Outcome Measures

En-block resesction rate [14 day]
conversion rate [1 day]
intervention time [1 day]
intra- and postoperative complications rate [30 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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