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

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.

Study Overview

• Status: Completed
• Conditions: Diverticulitis; Diverticular Disease; Diverticula
• Intervention / Treatment: Diagnostic test: Probe-based confocal laser endomicroscopy evaluation

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Ecuador
  • Guayas
    • Guayaquil, Guayas, Ecuador, 090505
      • Ecuadorian Institute of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with uncomplicated diverticular disease detected on colonoscopy and evaluation of peridiverticular and colonic mucosa assed via pCLE.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
• Investigators: Principal Investigator: Carlos Robles-Medranda, Ecuadorian Institute of Digestive Diseases

Publications and helpful links

General 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, Germana 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, 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.
• 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, Soreide 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, Pigo 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; diverticular disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulitis; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: PCLEDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No