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Completed

NCT Number: NCT01499576

Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Metaplasia Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology and Hepatology; Konyang University Hospital

Daejeon, 302-718, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Person who undergo gastroduodenoscopy
  • Person who visit Konyang University Hospital

Exclusion criteria

  • Bleeding diathesis
  • History of stomach neoplasms
  • History of upper gastrointestinal surgery

Treatment and study plan

Acetic acid chromoendoscopy

Procedure

Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Primary outcomes

  1. Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy

    Time frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)

    Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.

Secondary outcomes

  1. Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists

    Time frame: One month after the completion of the study

    The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.

    We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.

  2. Number of Participants With Adverse Events

    Time frame: up to 1week after the acetic acid chromoendoscopy

    Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.

Sponsors and collaborators

Lead sponsor

Konyang University Hospital

Other

Registry information

Official study title

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Acronym: IM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 26, 2011
Registry last updated
Sep 26, 2014

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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