Confocal Laser Endomicrospy in Colonic Diverticular Disease

Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173182
• Other study ID #: PCLEDD
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2022
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticula
• Diverticular Disease
• Diverticulitis
• Diverticulum

Intervention

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

Locations

Country	Name	City	State
Ecuador	Ecuadorian Institute of Digestive Diseases	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (4)

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, Germanà 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. — View Citation

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, Søreide 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, Pigò 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ocurrence of complicated diverticular disease	To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings	up to 12 months
Primary	ocurrence of complicated diverticular disease	To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings	up to 24 months
Secondary	peridiverticular and colonic mucosa inflammation based on pcle	• Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.	index procedure
Secondary	DICA classification	DICA classification system in all patients during initial colonoscopy.	index procedure
Secondary	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
Secondary	ocurrence of surgical intervention	• Ocurrence of surgical invertenvion for the management of complicated diverticular disease	12 months and 24 months