Skip to content

Confocal Laser Endomicrospy in Colonic Diverticular Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04173182
Enrollment
63
Registered
2019-11-21
Start date
2019-11-01
Completion date
2021-03-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticula, Diverticular Disease, Diverticulitis

Keywords

colonoscopy, diverticular disease

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.

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.

Interventions

DIAGNOSTIC_TESTProbe-based confocal laser endomicroscopy evaluation

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

Sponsors

Instituto Ecuatoriano de Enfermedades Digestivas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ocurrence of complicated diverticular diseaseup to 12 monthsTo predict the ocurrence of complications in colonic diverticular disease based on pCLE findings

Secondary

MeasureTime frameDescription
peridiverticular and colonic mucosa inflammation based on pcleindex procedure• Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.
DICA classificationindex procedureDICA classification system in all patients during initial colonoscopy.
ocurrence of complicated diverticular disease12 months and 24 monthsOcurrence of complicated diverticular disease, assed up to 12 months after enrollment based on Hinchey Classification (III-IV).
ocurrence of surgical intervention12 months and 24 months• Ocurrence of surgical invertenvion for the management of complicated diverticular disease

Countries

Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026