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CompletedNCT04173182Updated Mar 31, 2022

Confocal Laser Endomicrospy in Colonic Diverticular Disease

An observational study in Diverticular Disease, Diverticulitis and Diverticula, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Completed at 1 site in Ecuador. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diverticular Disease
  • Diverticulitis
  • Diverticula

Keywords

  • colonoscopy
  • diverticular disease
03

In context

Diverticular Diseases

44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.

This study's enrollment of 63 is below the median of 120 across 11 observational studies indexed under Diverticular Diseases.

Browse Diverticular Diseases studies →

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old.
  • Refuse to sign written .
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testProbe-based confocal laser endomicroscopy evaluation

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

06

What researchers measure

Primary outcomes

  1. ocurrence of complicated diverticular disease

    To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings

    Time frame: up to 12 months

  2. ocurrence of complicated diverticular disease

    To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings

    Time frame: up to 24 months

Secondary outcomes

  1. peridiverticular and colonic mucosa inflammation based on pcle

    • Presence of peridiverticular and colonic mucosa inflammation based on confocal laser endomicroscopy.

    Time frame: index procedure

  2. DICA classification

    DICA classification system in all patients during initial colonoscopy.

    Time frame: index procedure

  3. ocurrence of complicated diverticular disease

    Ocurrence of complicated diverticular disease, assed up to 12 months after enrollment based on Hinchey Classification (III-IV).

    Time frame: 12 months and 24 months

  4. ocurrence of surgical intervention

    • Ocurrence of surgical invertenvion for the management of complicated diverticular disease

    Time frame: 12 months and 24 months

07

Study locations

1 site
  • Ecuadorian Institute of Digestive Diseases
    Guayaquil, Guayas 090505, Ecuador
08

References and documents

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. PubMed 25531499 ↗
  • 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. PubMed 30851168 ↗
  • 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. PubMed 28861417 ↗
  • 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. PubMed 27536372 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Feb 2021, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2019
First posted
Nov 21, 2019
StartActual
Nov 1, 2019
Primary completionActual
Feb 1, 2021
CompletionActual
Mar 1, 2021
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04173182
Lead sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
Responsible party
Carlos Robles-Medranda (Head of the Endoscopy Division, Instituto Ecuatoriano de Enfermedades Digestivas) — Principal investigator
First posted
Nov 21, 2019
Start date
Nov 1, 2019
Primary completion
Feb 1, 2021
Completion
Mar 1, 2021
Last update
Mar 31, 2022

Study contacts

Carlos Robles-Medranda
principal investigator · Ecuadorian Institute of Digestive Diseases

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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