Confocal Laser Endomicrospy in Colonic Diverticular Disease
Study Details
Study Description
Brief Summary
Confocal laser endomicroscopy detects inflammatory markers undetectable during high definition endoscopy. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of the complicated diverticular disease using confocal laser endomicroscopy evaluation in the peridiverticular area in consecutive patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Diverticular disease of the colon is a prevalent condition in the western hemisphere. Currently there is an endoscopic classification system for classifying diverticular disease; however, white light endoscopic fails to accurately detect inflammation.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Inflammation on pCLE Patients with inflammatory findings in the peridiverticular and colonic mucosa (crypt fusion and distortion, bright epithelium, and dilated-prominent branching vessels) |
Diagnostic Test: 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) |
Diagnostic Test: Probe-based confocal laser endomicroscopy evaluation
Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
|
Outcome Measures
Primary Outcome Measures
- ocurrence of complicated diverticular disease [up to 12 months]
To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings
- ocurrence of complicated diverticular disease [up to 24 months]
To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings
Secondary Outcome Measures
- peridiverticular and colonic mucosa inflammation based on pcle [index procedure]
• Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.
- DICA classification [index procedure]
DICA classification system in all patients during initial colonoscopy.
- ocurrence of complicated diverticular disease [12 months and 24 months]
Ocurrence of complicated diverticular disease, assed up to 12 months after enrollment based on Hinchey Classification (III-IV).
- ocurrence of surgical intervention [12 months and 24 months]
• Ocurrence of surgical invertenvion for the management of complicated diverticular disease
Eligibility Criteria
Criteria
Inclusion Criteria:
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Above 18 years old
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Writeen informed consent provided.
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Endoscopic visualization of diverticular disease during colonoscopy.
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Adequate bowel preparation BBPS >2 in each colon segment
Exclusion Criteria:
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Under 18 years old.
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Refuse to sign written informed consent.
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Pregnancy or nursing.
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Previous colorectal surgery
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History of colorectal cancer
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Known allergy to fluorscein
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Uncontrolled coagulopathy
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History of complicated diverticular disease
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Patients with inflammatory bowel disease
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Patients with severe comorbidities: kidney and liver failure
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NSAIDs and antibiotics two weeks prior enrollment
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Historyh of alcohol or drug abuse
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Patients with severe mental illness
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Patients with incomplete evaluation of the colon
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ecuadorian Institute of Digestive Diseases | Guayaquil | Guayas | Ecuador | 090505 |
Sponsors and Collaborators
- Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
- Principal Investigator: Carlos Robles-Medranda, Ecuadorian Institute of Digestive Diseases
Study Documents (Full-Text)
None provided.More Information
Publications
- 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, Germanà 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, 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, Søreide 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, Pigò 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.
- 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.
- PCLEDD