Confocal Laser Endomicrospy in Colonic Diverticular Disease
NCT ID: NCT04173182
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
63 participants
OBSERVATIONAL
2019-11-01
2021-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endomicroscopy in Primary Sclerosing Cholangitis Related Inflammatory Bowel Disease Surveillance
NCT01880606
Validation of Clinical Efficacy and Development of New Diagnostic Algorithm of Probe-based Confocal Laser Endomicroscopy in Patients With Lower Gastrointestinal Disorder
NCT02091895
Confocal Probe-based Endoscopic Imaging, Colorectal Cancer, Gastrointestinal (GI) Pathologies
NCT00874263
Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
NCT03220711
Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis
NCT02676817
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Confocal laser endomicroscopy offers a real-time, in-vivo evaluation of the colonic mucosa, with an adequate correlation to histological findings. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of complicated diverticular disease.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inflammation on pCLE
Patients with inflammatory findings in the peridiverticular and colonic mucosa (crypt fusion and distortion, bright epithelium, and dilated-prominent branching vessels)
Probe-based confocal laser endomicroscopy evaluation
Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
No inflammation on pCLE
Patients with normal findings on pCLE evaluation of the peridiverticular and colonic mucosa (absence of inflammation)
Probe-based confocal laser endomicroscopy evaluation
Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probe-based confocal laser endomicroscopy evaluation
Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Writeen informed consent provided.
* Endoscopic visualization of diverticular disease during colonoscopy.
* Adequate bowel preparation BBPS \>2 in each colon segment
Exclusion Criteria
* Refuse to sign written informed consent.
* Pregnancy or nursing.
* Previous colorectal surgery
* History of colorectal cancer
* Known allergy to fluorscein
* Uncontrolled coagulopathy
* History of complicated diverticular disease
* Patients with inflammatory bowel disease
* Patients with severe comorbidities: kidney and liver failure
* NSAIDs and antibiotics two weeks prior enrollment
* Historyh of alcohol or drug abuse
* Patients with severe mental illness
* Patients with incomplete evaluation of the colon
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carlos Robles-Medranda
Head of the Endoscopy Division
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos Robles-Medranda
Role: PRINCIPAL_INVESTIGATOR
Ecuadorian Institute of Digestive Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ecuadorian Institute of Digestive Diseases
Guayaquil, Guayas, Ecuador
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Tursi A, Brandimarte G, Di Mario F, Andreoli A, Annunziata ML, Astegiano M, Bianco MA, Buri L, Cammarota G, Capezzuto E, Chilovi F, Cianci M, Conigliaro R, Del Favero G, Di Cesare L, Di Fonzo M, Elisei W, Faggiani R, Farroni F, Forti G, Germana B, Giorgetti GM, Giovannone M, Lecca PG, Loperfido S, Marmo R, Morucci P, Occhigrossi G, Penna A, Rossi AF, Spadaccini A, Zampaletta C, Zilli M, Zullo A, Scarpignato C, Picchio M. Development and validation of an endoscopic classification of diverticular disease of the colon: the DICA classification. Dig Dis. 2015;33(1):68-76. doi: 10.1159/000366039. Epub 2014 Dec 17.
Tursi A, Brandimarte G, di Mario F, Nardone G, Scarpignato C, Picchio M, Elisei W; DICA Italian Group. The "DICA" endoscopic classification for diverticular disease of the colon shows a significant interobserver agreement among community endoscopists. J Gastrointestin Liver Dis. 2019 Mar;28(1):23-27. doi: 10.15403/jgld.2014.1121.281.dic.
Tursi A, Elisei W, Picchio M, Nasi G, Mastromatteo AM, Di Mario F, Di Rosa E, Brandimarte MA, Brandimarte G. Impact of diverticular inflammation and complication assessment classification on the burden of medical therapies in preventing diverticular disease complications in Italy. Ann Transl Med. 2017 Aug;5(16):320. doi: 10.21037/atm.2017.06.39.
Tursi A, Brandimarte G, Di Mario F, Annunziata ML, Bafutto M, Bianco MA, Colucci R, Conigliaro R, Danese S, De Bastiani R, Elisei W, Escalante R, Faggiani R, Ferrini L, Forti G, Latella G, Graziani MG, Oliveira EC, Papa A, Penna A, Portincasa P, Soreide K, Spadaccini A, Usai P, Bonovas S, Scarpignato C, Picchio M; DICA Collaborative Group: Luigi Di Cesare; Lecca PG, Zampaletta C, Cassieri C, Damiani A, Desserud KF, Fiorella S, Landi R, Goni E, Lai MA, Pigo F, Rotondano G, Schiaccianoce G. Predictive value of the Diverticular Inflammation and Complication Assessment (DICA) endoscopic classification on the outcome of diverticular disease of the colon: An international study. United European Gastroenterol J. 2016 Aug;4(4):604-13. doi: 10.1177/2050640615617636. Epub 2015 Nov 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCLEDD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.