Confocal Laser Endomicrospy in Colonic Diverticular Disease

Completed

• Conditions: Diverticula; Diverticulitis; Diverticular Disease
• Interventions: Diagnostic Test: Probe-based confocal laser endomicroscopy evaluation

• Registration Number: NCT04173182
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inflammation on pCLE	Probe-based confocal laser endomicroscopy evaluation	Patients with inflammatory findings in the peridiverticular and colonic mucosa (crypt fusion and distortion, bright epithelium, and dilated-prominent branching vessels)
No inflammation on pCLE	Probe-based confocal laser endomicroscopy evaluation	Patients with normal findings on pCLE evaluation of the peridiverticular and colonic mucosa (absence of inflammation)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
DICA classification	index procedure	DICA classification system in all patients during initial colonoscopy.
ocurrence of surgical intervention	12 months and 24 months	• Ocurrence of surgical invertenvion for the management of complicated diverticular disease
peridiverticular and colonic mucosa inflammation based on pcle	index procedure	• Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.
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).

Trial Locations

Locations (1)

Ecuadorian Institute of Digestive Diseases; 🇪🇨 Guayaquil, Guayas, Ecuador