Enhanced Magnifying Endoscopy for Diagnosis of Early Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, China
Information provided by (Responsible Party):
Xinghua Lu, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01617876
First received: June 9, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

When performing screening endoscopy, small focal gastric lesions are frequently encountered. Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been proposed in the recognition of early gastric cancer (EGC).

This study is based on the hypothesis as follow:

  1. The microvascular structure could be clearly observed with magnifying endoscopy enhanced by narrow-band imaging (ME-NBI).
  2. The microsurface architecture could be clearly observed with magnifying endoscopy enhanced by acetic acid-indigocarmine mixture (ME-AIM).
  3. Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE), has higher sensitivity and specificity for the differential diagnosing small focal gastric lesions.

Condition
Stomach Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.


Secondary Outcome Measures:
  • Diagnostic accuracy of WLE [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    WLE diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of WLE diagnosis compared with histopathology diagnosis were measured.

  • The relationships between the microvascular patterns and the histopathological findings [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The microvascular pattern of each lesion was evaluated subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of distribution of different microvascular patterns compared with histopathology diagnosis was measured.

  • The relationships between the microsurface patterns and the histopathological findings [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The microsurface pattern of each lesion was evaluated subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of distribution of different microsurface patterns compared with histopathology diagnosis was measured.


Biospecimen Retention:   Samples Without DNA

Biopsy of gastric lesions


Enrollment: 282
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion. WLE without magnification was performed first in eligible patients. Based on an assessment of the shape (such as flat, depressed or elevated) and color (pale or reddened), small focal gastric lesions were identified and included for evaluation by experienced endoscopists. When such a lesion was detected during non-magnifying observation with WLE, the mode was then changed to ME-NBI for observation of microvascular pattern and ME-AIM for observation of microsurface pattern subsequently. All endoscopic images of the whole procedure were recorded in digital filing system for later evaluation. To avoid possible selection bias and to maintain the quality of the study, all images of each endoscopic modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one slide and displayed independently of the images of other endoscopic modality, were evaluated by 4 skilled endoscopists, who were not access to the clinical and pathological data. The general consensus was established for an assessment of each lesion. Two forceps biopsy specimens were taken from each lesion and pathological diagnosis were used as the criterion standard for cancer diagnosis.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion.

Criteria

Inclusion Criteria:

  • Patients, in which small focal gastric lesions were identified with conventional WLE, were enrolled in this study. Before being enrolled, all patients provided written informed consent.

Exclusion Criteria:

  • Patients who cannot undergo gastroscopies due to unsuitable conditions
  • Referred patients with a history of having being diagnosed as gastric cancer
  • Patients with a personal history of gastric surgery
  • Patients who cannot provide informed consent
  • Patients with advanced gastric cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617876

Locations
China
Department of Gastroenterology, Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Ministry of Health, China
Investigators
Principal Investigator: Xinghua Lu, Dr Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Xinghua Lu, Chairman of Beijing Institute of Digestive Endoscopy of Chinese Medical Association, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01617876     History of Changes
Other Study ID Numbers: LXH-EGC-1, 200902002
Study First Received: June 9, 2012
Last Updated: June 9, 2012
Health Authority: China: Ministry of Health
China: Ministry of Science and Technology

Keywords provided by Peking Union Medical College Hospital:
Stomach Neoplasms
early gastric cancer
magnifying endoscopy
narrow band imaging
acetic acid
indigocarmine

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 27, 2014