Confocal Laser Endomicrospy in Colonic Diverticular Disease

NCT04173182 | Completed DMC

• 1 other identifier: PCLEDD
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticular Disease; Diverticulitis; Diverticula

Keywords

colonoscopy; diverticular disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• peridiverticular and colonic mucosa inflammation based on pcle

  index procedure

• DICA classification

  index procedure

• ocurrence of complicated diverticular disease

  12 months and 24 months

• ocurrence of surgical intervention

  12 months and 24 months

Study Arms (2)

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

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

Interventions

Probe-based confocal laser endomicroscopy evaluation DIAGNOSTIC_TEST

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

Inflammation on pCLE; No inflammation on pCLE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Above 18 years old
• Writeen informed consent provided.
• Endoscopic visualization of diverticular disease during colonoscopy.
• Adequate bowel preparation BBPS \>2 in each colon segment

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

Location

Related 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, 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.

  PMID: 25531499 BACKGROUND

• 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.

  PMID: 30851168 BACKGROUND

• 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.

  PMID: 28861417 BACKGROUND

• 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.

  PMID: 27536372 BACKGROUND

MeSH Terms

Conditions

Diverticular Diseases; Diverticulitis; Diverticulum

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Robles-Medranda

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Endoscopy Division

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 21, 2019
• Study Start: November 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)