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Completed

NCT Number: NCT03672708

Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia

Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye

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Key information

Conditions

Gastric Intestinal Metaplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
  • patients with H. pylori infection, or known GIM or atrophic gastritis

Exclusion criteria

  • patients with a history of GI surgery
  • advanced gastric carcinoma or any other malignancy in the GI tract
  • acute upper GI bleeding
  • patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
  • patients refused to provide informed consent

Treatment and study plan

Cresyl violet

Diagnostic Test

cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE

Primary outcomes

  1. feasibility of CV for identifying GIM

    Time frame: 1 month

    ratio of pCLE failure to visualize the cellular and subcellular structures

  2. feasibility of CV for identifying GIM

    Time frame: 1 month

    ratio of pCLE failure to recognize lesions and their immediate characterization

  3. newly pCLE criteria with CV application for GIM

    Time frame: 1 month

    ratio of diagnostic agreement between pCLE using CV and histopathological results

  4. newly pCLE criteria with CV application for GIM

    Time frame: 1 month

    number of diagnostic agreement between pCLE with CV application and histopathological results

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
May 14, 2019

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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