Back to resultsTargeted Forceps Biopsy for Colorectal Tumors
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Targeted group
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring forceps biopsy, colorectal tumors
Eligibility Criteria
Inclusion Criteria:
- Patients with colorectal neoplasms of the size larger than 2 cm
Exclusion Criteria:
- Patients who deny the participation in the study
Sites / Locations
- Kyungpook National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Targeted forceps biopsy
Conventional forceps biopsy
Arm Description
In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation.
In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors.
Outcomes
Primary Outcome Measures
pathologic diagnosis
The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.
Secondary Outcome Measures
Full Information
NCT ID
NCT03604237
First Posted
July 19, 2018
Last Updated
July 19, 2018
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03604237
Brief Title
Targeted Forceps Biopsy for Colorectal Tumors
Official Title
Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
forceps biopsy, colorectal tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Targeted forceps biopsy
Arm Type
Experimental
Arm Description
In this group, an endoscopist takes a forceps biopsy at depressed mucosa or large nodular area of large colorectal tumors after meticulous surface evaluation.
Arm Title
Conventional forceps biopsy
Arm Type
No Intervention
Arm Description
In this group, an endoscopist takes a forceps biopsy at the most convenient area of large colorectal tumors.
Intervention Type
Diagnostic Test
Intervention Name(s)
Targeted group
Intervention Description
Forceps biopsy is taken after surface evaluation of the large colorectal tumors.
Primary Outcome Measure Information:
Title
pathologic diagnosis
Description
The pathologic diagnosis of forceps biopsy is compared with the pathologic diagnosis of resected specimen of the colorectal tumor.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal neoplasms of the size larger than 2 cm
Exclusion Criteria:
Patients who deny the participation in the study
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Soo Kim, MD, PhD
Phone
+82-53-200-5879
Email
dandy813@hanmail.net
12. IPD Sharing Statement
Learn more about this trial
Targeted Forceps Biopsy for Colorectal Tumors
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