Confocal Laser Endomicrospy in Colonic Diverticular Disease

Instituto Ecuatoriano de Enfermedades Digestivas63 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Diverticular Disease Diverticulitis Diverticula

Interventions

Probe-based confocal laser endomicroscopy evaluationDIAGNOSTIC_TEST

Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, Ecuador

Outcomes

Primary Outcomes

ocurrence of complicated diverticular disease

To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings

Time frame: up to 12 months

ocurrence of complicated diverticular disease

To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings

Time frame: up to 24 months

Secondary Outcomes

peridiverticular and colonic mucosa inflammation based on pcle

• Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.

Time frame: index procedure

DICA classification

DICA classification system in all patients during initial colonoscopy.

Time frame: 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).

Time frame: 12 months and 24 months

ocurrence of surgical intervention

• Ocurrence of surgical invertenvion for the management of complicated diverticular disease

Time frame: 12 months and 24 months

Data from ClinicalTrials.gov

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