Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

Trial Title: Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

NCT ID: NCT05690490

Condition: Endoscopic Mucosal Resection With Circumferential Incision

Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Surgical Wound

Conditions: Keywords:
C-EMR
Endoscopic treatment
colorectal neoplasm
circumferential incision

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: prospective, single-center, randomized, non inferiority

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Endoscopic mucosal resection with circumferential incision
Description: 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.
Arm group label: endoscopic mucosal resection with circumferential incision

Intervention type: Procedure
Intervention name: Endoscopic submucosal dissection
Description: 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 group label: endoscopic submucosal dissection

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Elmira

Address:
City: Moscow
Country: Russian Federation

Start date: November 27, 2020

Completion date: November 27, 2023

Lead sponsor:
Agency: State Scientific Centre of Coloproctology, Russian Federation
Agency class: Other

Source: State Scientific Centre of Coloproctology, Russian Federation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05690490