NCT05690490

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

January 18, 2021

Last Update Submit

January 10, 2023

Conditions

Endoscopic Mucosal Resection With Circumferential Incision

Keywords

C-EMREndoscopic treatmentcolorectal neoplasmcircumferential incision

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    14 day

Secondary Outcomes (4)

  • En-block resesction rate

    14 day

  • conversion rate

    1 day

  • intervention time

    1 day

  • intra- and postoperative complications rate

    30 day

Study Arms (2)

endoscopic mucosal resection with circumferential incision

EXPERIMENTAL

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

endoscopic submucosal dissection

ACTIVE COMPARATOR

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

Interventions

Endoscopic mucosal resection with circumferential incisionPROCEDURE

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 mucosal resection with circumferential incision
Endoscopic submucosal dissectionPROCEDURE

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.

endoscopic submucosal dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unsatisfactory tumor lifting
  • refusal of the patient from research at any stage of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elmira

Moscow, Russia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, single-center, randomized, non inferiority
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 19, 2023

Study Start

November 27, 2020

Primary Completion

September 27, 2023

Study Completion

November 27, 2023

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

RU(1)