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Completed

NCT Number: NCT04173182

Confocal Laser Endomicrospy in Colonic 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.

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Key information

Conditions

Diverticular Disease Digestive System Diseases Diverticula Diverticular Diseases Diverticulitis Diverticulum Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. ocurrence of complicated diverticular disease

    Time frame: up to 12 months

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

  2. ocurrence of complicated diverticular disease

    Time frame: up to 24 months

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

Secondary outcomes

  1. peridiverticular and colonic mucosa inflammation based on pcle

    Time frame: index procedure

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

  2. DICA classification

    Time frame: index procedure

    DICA classification system in all patients during initial colonoscopy.

  3. ocurrence of complicated diverticular disease

    Time frame: 12 months and 24 months

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

  4. ocurrence of surgical intervention

    Time frame: 12 months and 24 months

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

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2019
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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