Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

Not Applicable

Active, not recruiting

• Conditions: Endoscopic Mucosal Resection With Circumferential Incision
• Interventions: Procedure: Endoscopic submucosal dissection; Procedure: Endoscopic mucosal resection with circumferential incision

• Registration Number: NCT05690490
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2020-11-27
• Study First Submitted: 2021-01-18
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-09-27
• Study Completion: 2023-11-27

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic submucosal dissection	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.
endoscopic mucosal resection with circumferential incision	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.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	14 day

Secondary Outcome Measures

Name	Time	Method
intervention time	1 day
conversion rate	1 day
En-block resesction rate	14 day
intra- and postoperative complications rate	30 day

Trial Locations

Locations (1)

Elmira; 🇷🇺 Moscow, Russian Federation