Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

NCT ID: NCT05690490

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-27
• Study Completion Date: 2023-11-27

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.

Conditions

Endoscopic Mucosal Resection With Circumferential Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endoscopic mucosal resection with circumferential incision

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic submucosal dissection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Elmira

Moscow, , Russia

Countries

Russia

Other Identifiers

26/20

Identifier Type: -

Identifier Source: org_study_id