Colonic Polyp Clinical Trial
Official title:
Linked Color Imaging (LCI) Versus Standard White-light Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial
Verified date | October 2019 |
Source | Valduce Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that
differentiates the red color spectrum more effectively than white light imaging thanks to its
optimal pre-process composition of light spectrum and advanced signal processing. This
technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo,
Japan) with new high-performance LED illumination system, enhances the visibility of colonic
mucosal vessels and might increase the detection rate of colorectal polyps. Data available
regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and
limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is
superior to WL endoscopy in terms of adenoma detection
Status | Completed |
Enrollment | 600 |
Est. completion date | September 1, 2019 |
Est. primary completion date | June 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 72 Years |
Eligibility |
Inclusion Criteria: - 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (FIT) Exclusion Criteria: - subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of CRC, colonic adenomas or IBD, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease) - patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment) - patients with previous colonic resection - patients on antithrombotic therapy, precluding polyp resection - patients who were not able or refused to give informed written consent. |
Country | Name | City | State |
---|---|---|---|
Italy | Gastroenterology Unit, Valduce Hospital | Como |
Lead Sponsor | Collaborator |
---|---|
Valduce Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma Detection Rate | proportion of participants with at least one adenoma (per-patient analysis) | 1 year | |
Secondary | advanced adenoma detection rate | proportion of participants with at least one advanced adenoma | 1 year | |
Secondary | mean number per subject of polyps, adenomas, advanced adenomas and sessile serrated lesions | total number of detected lesions in each group divided by the total number of participants | 1 year | |
Secondary | Withdrawal time | time for mucosal inspection only | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03272945 -
Linked-color Imaging for the Detection of Colorectal Flat Lesions
|
N/A | |
Recruiting |
NCT06062095 -
Computer Aided Diagnosis (CADx) for Colorectal Polyps Resect-and-Discard Strategy
|
N/A | |
Not yet recruiting |
NCT02688699 -
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
|
Phase 4 | |
Active, not recruiting |
NCT03962868 -
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial
|
N/A | |
Not yet recruiting |
NCT05776381 -
The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp
|
Phase 2 | |
Recruiting |
NCT04157803 -
Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps
|
N/A | |
Completed |
NCT03758872 -
CUFF-assisted Colonoscopy vs Standard Colonoscopy
|
||
Recruiting |
NCT05870332 -
Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
|
||
Recruiting |
NCT04149184 -
Computer-aided Detection Device in Standard Colonoscopy
|
N/A | |
Active, not recruiting |
NCT03865537 -
Cold Snare Endoscopic Mucosal Resection Trial
|
N/A | |
Recruiting |
NCT05099432 -
The CARMA Technique Study
|
N/A | |
Withdrawn |
NCT04778566 -
Evaluating the Cologuard Test for Use in Lynch Syndrome
|
||
Withdrawn |
NCT01372696 -
Endoscopic Characteristics of Colonic Tumours
|
N/A | |
Recruiting |
NCT05322993 -
Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy
|
N/A | |
Completed |
NCT03121495 -
Study on Second Forward View Examination in the Right Colon
|
N/A | |
Completed |
NCT03344055 -
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate
|
N/A | |
Recruiting |
NCT06063720 -
Effective Withdrawal Time and Adenoma Detection Rate
|
||
Completed |
NCT06426745 -
Split-dose Versus Single-dose Bowel Preparation for Colonoscopy
|
N/A | |
Recruiting |
NCT04220905 -
Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
|
||
Completed |
NCT04693078 -
Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System
|
N/A |