Confocal Laser Endomicrospy in Colonic Diverticular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Peridiverticular and Colonic Mucosa Inflammation Based on Confocal Laser Endomicroscopy in the Prediction of Complicated Diverticular Disease

Conditions
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Diverticular Disease, Diverticulitis, Diverticula

Intervention / Treatment
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* Diagnostic Test: Probe-based confocal laser endomicroscopy evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years old Writeen informed consent provided. Endoscopic visualization of diverticular disease during colonoscopy. Adequate bowel preparation BBPS >2 in each colon segment Exclusion Criteria: Under 18 years old. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammation on pCLE<br>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<br>* Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease<br>|
| No inflammation on pCLE<br>Patients with normal findings on pCLE evaluation of the peridiverticular and colonic mucosa (absence of inflammation) | Diagnostic Test: Probe-based confocal laser endomicroscopy evaluation<br>* Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ocurrence of complicated diverticular disease | To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings | up to 12 months | 
| ocurrence of complicated diverticular disease | To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peridiverticular and colonic mucosa inflammation based on pcle | • Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy. | index procedure | 
| DICA classification | DICA classification system in all patients during initial colonoscopy. | index procedure | 
| ocurrence of complicated diverticular disease | Ocurrence of complicated diverticular disease, assed up to 12 months after enrollment based on Hinchey Classification (III-IV). | 12 months and 24 months | 
| ocurrence of surgical intervention | • Ocurrence of surgical invertenvion for the management of complicated diverticular disease | 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, diverticular disease