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

Primary Purpose

Endoscopic Mucosal Resection With Circumferential Incision

Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Endoscopic mucosal resection with circumferential incision
Endoscopic submucosal dissection
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopic Mucosal Resection With Circumferential Incision focused on measuring C-EMR, Endoscopic treatment, colorectal neoplasm, circumferential incision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Elmira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endoscopic mucosal resection with circumferential incision

endoscopic submucosal dissection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

R0 resection rate

Secondary Outcome Measures

En-block resesction rate
conversion rate
intervention time
intra- and postoperative complications rate

Full Information

First Posted
January 18, 2021
Last Updated
January 10, 2023
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT05690490
Brief Title
Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms
Acronym
C-EMR
Official Title
Treament for Colorectal Neoplasms by Metod Endoscopic Mucosal Resection With Circumferential Mucosal Incision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
November 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Mucosal Resection With Circumferential Incision
Keywords
C-EMR, Endoscopic treatment, colorectal neoplasm, circumferential incision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, single-center, randomized, non inferiority
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endoscopic mucosal resection with circumferential incision
Arm Type
Experimental
Arm Description
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.
Arm Title
endoscopic submucosal dissection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic mucosal resection with circumferential incision
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic submucosal dissection
Intervention 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.
Primary Outcome Measure Information:
Title
R0 resection rate
Time Frame
14 day
Secondary Outcome Measure Information:
Title
En-block resesction rate
Time Frame
14 day
Title
conversion rate
Time Frame
1 day
Title
intervention time
Time Frame
1 day
Title
intra- and postoperative complications rate
Time Frame
30 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Elmira
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

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Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms

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