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Completed

NCT Number: NCT01688687

Conventional Biopsies vs pCLE for Diagnosis of Superficial Gastric Neoplasia

Confocal endomicroscopy (CLE) allows real-time in-vivo high-resolution and high-magnification imaging of the gastrointestinal epithelium, which is comparable to histopathology. Previous studies have investigated the accuracy of pCLE for diagnosis and differentiated of colorectal polyps, Barrett's esophagus and pancreaticobiliary strictures. However, to date there are limited data exploring the application of pCLE to gastric lesions, and this is the first study comparing the diagnosis of conventional forceps biopsy with that of pCLE using the final specimens obtained from endoscopic resection as a reference standard. The aims of this study were (1) the accuracy of pCLE compared to conventional forceps biopsy using histopathology results following endoscopic resection as a reference, and (2) comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis, and off-line interobserver agreement.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastric Dysplasia Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Soonchunhyang University Seoul Hospital

Seoul, 140-743, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with biospy proven superficial gastric neoplasia, suitable for endoscopic resection.

Exclusion criteria

  • Patients with uncorrectable coagulopathy,
  • liver cirrhosis,
  • acute gastrointestinal bleeding,
  • pregnancy,
  • breast feeding,
  • documented allergy to fluorescein,
  • patients with lesions that were deemed unsuitable for endoscopic resection, and
  • patients without documented conventional biopsy results.

Treatment and study plan

Endoscopic submucosal dissection

Procedure

Primary outcomes

  1. The accuracy of pCLE compared to conventional forceps biopsy

    Time frame: in-vivo pCLE accuracy compared to conventional forceps biopsy was assessed 1-2 weeks prior to endoscopic resection.

    The accuracy of pCLE compared to conventional forceps biopsy was assessed using histopathology results following endoscopic resection as a reference

Secondary outcomes

  1. Comparison of "real time" in-vivo pCLE diagnosis with that of blinded "off-line" pCLE diagnosis.

    Time frame: 1-3 months after endoscopic resection and final histopathological analysis

  2. Off-line pCLE interobserver agreement

    Time frame: 1-3 months after endoscopic resection and final histopathological analysis

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

The Accuracy of Probe-based Confocal Endomicroscopy Versus Conventional Biopsies for the Diagnosis of Superficial Gastric Neoplasias

Acronym: pCLE

Important dates

Study start
2012
Primary completion
2012
First posted
Sep 20, 2012
Registry last updated
Sep 20, 2012

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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