- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05690490
Endoscopic Mucosal Resection With Circumferential Incision for Colorectal Neoplasms (C-EMR)
January 10, 2023 updated by: State Scientific Centre of Coloproctology, Russian Federation
Treament for Colorectal Neoplasms by Metod Endoscopic Mucosal Resection With Circumferential Mucosal Incision
This is a prospective randomized trial to improve the results of treatment of patients with colorectal neoplasms.
Study Overview
Status
Active, not recruiting
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 Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Moscow, Russian Federation
- Elmira
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
R0 resection rate
Time Frame: 14 day
|
14 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
En-block resesction rate
Time Frame: 14 day
|
14 day
|
conversion rate
Time Frame: 1 day
|
1 day
|
intervention time
Time Frame: 1 day
|
1 day
|
intra- and postoperative complications rate
Time Frame: 30 day
|
30 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2020
Primary Completion (Anticipated)
September 27, 2023
Study Completion (Anticipated)
November 27, 2023
Study Registration Dates
First Submitted
January 18, 2021
First Submitted That Met QC Criteria
January 10, 2023
First Posted (Estimate)
January 19, 2023
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 10, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26/20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endoscopic Mucosal Resection With Circumferential Incision
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Azienda Ospedaliera Universitaria SeneseAzienda Ospedaliera Niguarda Cà Granda; Azienda USL 1 ImperieseUnknownEndoscopic Mucosal ResectionItaly
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Germans Trias i Pujol HospitalCompletedEvaluation of the Efficacy of Platelet-rich Plasma (PRP) on Advanced Endoscopic Resection TechniquesEndoscopic Submucosal Dissection | Platelet-rich Plasma | Endoscopic Mucosal ResectionSpain
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Western Sydney Local Health DistrictCompletedPain | Endoscopic Mucosal ResectionAustralia
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Michael WallaceOlympus America, Inc.CompletedPost-endoscopic Mucosal Resection of Colon PolypsUnited States
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Western Sydney Local Health DistrictCompletedEndoscopic Mucosal Resection | Delayed Bleeding Post EMR | Large Laterally Spreading Lesion in the ColonAustralia
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Dong YangUnknownLaparoscopy-assisted Surgery | Total Laparoscopic Surgery With no Incision (Natural Orifice Transluminal Endoscopic Surgery, NOSES)China
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Interscope, Inc.CompletedPolyp of Colon | Endoscopic Mucosal Resection | Recurrent Colon AdenomaUnited States, France, Italy, Germany
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Clinical Trials on Endoscopic mucosal resection with circumferential incision
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Professor Michael BourkeWithdrawn
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Professor Michael BourkeRecruitingAdenoma, VillousAustralia
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Professor Michael BourkeRecruitingAdenoma, VillousAustralia
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Western Sydney Local Health DistrictNot yet recruitingColon Cancer | Colon Adenoma | Colorectal PolypAustralia
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Professor Michael BourkeCompletedColonic PolypsAustralia
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University of British ColumbiaRecruitingColon Adenoma | Colon Polyp | Colon LesionCanada
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Massachusetts General HospitalCompletedConstipation | Hirschsprung DiseaseUnited States