Polyp of Colon Clinical Trial
— LCIScarOfficial title:
Linked Color Imaging vs. High-definition White Light Endoscopy for the Evaluation of Post-polypectomy Scars of Non-pedunculated Polyps. A Randomized Controlled Cross-over Trial. (LCI-Scar Study).
Verified date | August 2022 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Careful inspection and evaluation of the post-polipectomy scars of polyps greater than 20 mm looking for residual polyp is mandatory. LCI has demonstrated to improve polyp and adenoma detection rate in previous studies. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. So, our aim is to compare the efficacy of linked color imaging for optical diagnosis of post-polypectomy scar recurrence compared with high-definition white light endoscopy.
Status | Completed |
Enrollment | 173 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Any patient =18 years undergoing surveillance colonoscopy after a previous polypectomy of one or more non-pedunculated polyps greater than 15 mm. - Provide informed consent. Exclusion Criteria: - Inflamatory bowel disease |
Country | Name | City | State |
---|---|---|---|
Spain | María Pellisé. MD. PhD. | Barcelona | |
Spain | Oswaldo ortiz | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | European Society of Gastrointestinal Endoscopy |
Spain,
Bisschops R, East JE, Hassan C, Hazewinkel Y, Kaminski MF, Neumann H, Pellisé M, Antonelli G, Bustamante Balen M, Coron E, Cortas G, Iacucci M, Yuichi M, Longcroft-Wheaton G, Mouzyka S, Pilonis N, Puig I, van Hooft JE, Dekker E. Advanced imaging for detec — View Citation
Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project fo — View Citation
Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. — View Citation
Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem col — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of recurrence on postpolypectomy scars with White light endoscopy | 2 years | ||
Primary | Number of recurrence on postpolypectomy scars with LCI | 2 years | ||
Primary | Number of recurrence on postpolypectomy scars detected with AI | 2 years | ||
Secondary | Elapsed time | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05178095 -
Artificial Intelligence in Colonic Polyp Detection
|
N/A | |
Completed |
NCT03179358 -
Clinical Trial Verifying C-REX LapAid and C-REX DMH/DMHC
|
N/A | |
Completed |
NCT04551014 -
Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm
|
N/A | |
Completed |
NCT04551001 -
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy
|
N/A | |
Completed |
NCT04378660 -
Artificial Intelligence (AI) Validation Study for Polyp Detection
|
N/A | |
Completed |
NCT04442607 -
Clinical vAliDation of ARTificial Intelligence in POlyp Detection
|
N/A | |
Completed |
NCT05499546 -
Virtual Scale Function SCALE EYE: Variability and Systematic Differences
|
N/A | |
Completed |
NCT04195646 -
Computer Aided Detection of Polyps During Colonoscopy Procedures
|
N/A | |
Recruiting |
NCT04500392 -
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity
|
N/A | |
Recruiting |
NCT06447012 -
Artificial Intelligence Development for Colorectal Polyp Diagnosis
|
||
Completed |
NCT04357158 -
Breath Analysis as an Additional Test for Colorectal Cancer Screening to Reduce the Number of Unnecessary Colonoscopies
|
N/A | |
Completed |
NCT05389397 -
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
|
N/A | |
Completed |
NCT04032912 -
The Non-Optical Resect and Discard Study (NORD)
|
||
Recruiting |
NCT05730192 -
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
|
N/A | |
Completed |
NCT05829447 -
Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals
|
N/A | |
Completed |
NCT04647266 -
Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions
|
||
Not yet recruiting |
NCT06271941 -
Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
|
N/A | |
Recruiting |
NCT04117100 -
Advanced Endo-therapeutic Procedure : Registry-based Observational Study
|
||
Active, not recruiting |
NCT03089268 -
Molecular and Histological Characteristics of Serrated Lesions of the Colon
|
||
Completed |
NCT04924543 -
OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD
|
N/A |