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NCT Number: NCT02738294

Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

The aim of the present study was to assess whether it was necessary to conduct magnifying endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile, the investigators proposed the most cost-effective way to diagnose EGC.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200001, China

About this study

ME-NBI has been widely used for the diagnosis of stomach diseases, especially in the early diagnosis of gastric cancer. The aim of the present study was to evaluate diagnostic efficacy of ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy compared with EFB from white light endoscopy and ME-NBI combined with EFB.

A prospective study was conducted encompassing suspected EGC. All patients were performed white light endoscopic examination with EFB and then ME-NBI with ME-NBI targeted biopsy. Outcome measures were assessed and compared, including diagnostic efficacy of EFB from white light endoscopy,ME-NBI combined with EFB, ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • consecutive patients with gastric lesions detected by white light endoscopy and suspected of EGC

Exclusion criteria

  • they had advanced gastric cancer
  • lesions were histopathologically confirmed to be submucosal tumors
  • they had a history of gastrectomy
  • tissue biopsy wasn't obtained or more than 2 biopsies were performed on suspected gastric lesions during last white light endoscopy
  • they couldn't tolerate another endoscopic examination

Treatment and study plan

ME-NBI observation and ME-NBI targeted biopsy

Device

The endoscopist assessed lesions which were suspected EGC carefully with ME-NBI. After assessing suspected EGC in ME-NBI view, ME-NBI targeted biopsy was performed where abnormal phenomenon was identified in ME-NBI view.

Primary outcomes

  1. Accuracy in distinguishing high-grade neoplasia (HGN) from non-HGN

    Time frame: 30 months

    EFB and ME-NBI targeted biopsy and final resected specimens were assessed according to the Vienna classification. Suspected lesions were assessed in ME-NBI view according to the diagnostic classification proposed by Yao and Ezoe et al. However, little different from their classification, lesions were classified into positive HGN phenomenon, indefinite and suspected HGN, negative HGN phenomenon. After that, ME-NBI targeted biopsy was performed where abnormal or suspected phenomenon was observed. Compared with final pathology of endoscopic submucosal dissection (ESD) or surgery specimens, sensitivity of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated. Accuracy of EFB and ME-NBI targeted biopsy was compared using McNemar test. The same method was used to compare ME-NBI combined EFB and ME-NBI combined targeted biopsy.

  2. Sensitivity in distinguishing HGN from non-HGN

    Time frame: 30 months

    EFB and ME-NBI targeted biopsy and final resected specimens were assessed according to the Vienna classification. Suspected lesions were assessed in ME-NBI view according to the diagnostic classification proposed by Yao and Ezoe et al. However, little different from their classification, lesions were classified into positive HGN phenomenon, indefinite and suspected HGN, negative HGN phenomenon. The former classification was diagnosed as HGN. The latter two classification was diagnosed as HGN. After that, ME-NBI targeted biopsy was performed where abnormal or suspected phenomenon was observed. Compared with final pathology of ESD or surgery specimens, sensitivity of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated. Sensitivity of EFB and ME-NBI targeted biopsy was compared using McNemar test. The same method was used to compare ME-NBI combined EFB and ME-NBI combined targeted biopsy.

  3. Specificity in distinguishing HGN from non-HGN

    Time frame: 30 months

    EFB and ME-NBI targeted biopsy and final resected specimens were assessed according to the Vienna classification. Suspected lesions were assessed in ME-NBI view according to the diagnostic classification proposed by Yao and Ezoe et al. However, little different from their classification, lesions were classified into positive HGN phenomenon, indefinite and suspected HGN, negative HGN phenomenon. The former classification was diagnosed as HGN. The latter two classification was diagnosed as HGN. After that, ME-NBI targeted biopsy was performed where abnormal or suspected phenomenon was observed. Compared with final pathology of ESD or surgery specimens, specificity of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated. Specificity of EFB and ME-NBI targeted biopsy was compared using McNemar test. The same method was used to compare ME-NBI combined EFB and ME-NBI combined targeted biopsy.

Secondary outcomes

  1. Positive predictive value (PPV) in distinguishing HGN from non-HGN

    Time frame: 30 months

    EFB and ME-NBI targeted biopsy and final resected specimens were assessed according to the Vienna classification. Suspected lesions were assessed in ME-NBI view according to the diagnostic classification proposed by Yao and Ezoe et al. However, little different from their classification, lesions were classified into positive HGN phenomenon, indefinite and suspected HGN, negative HGN phenomenon. The former classification was diagnosed as HGN. The latter two classification was diagnosed as HGN. After that, ME-NBI targeted biopsy was performed where abnormal or suspected phenomenon was observed. Compared with final pathology of ESD or surgery specimens, PPV of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated.

  2. Negative predictive value (NPV) in distinguishing HGN from non-HGN

    Time frame: 30 months

    EFB and ME-NBI targeted biopsy and final resected specimens were assessed according to the Vienna classification. Suspected lesions were assessed in ME-NBI view according to the diagnostic classification proposed by Yao and Ezoe et al. However, little different from their classification, lesions were classified into positive HGN phenomenon, indefinite and suspected HGN, negative HGN phenomenon. The former classification was diagnosed as HGN. The latter two classification was diagnosed as HGN. After that, ME-NBI targeted biopsy was performed where abnormal or suspected phenomenon was observed. Compared with final pathology of ESD or surgery specimens, NPV of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Necessity Assessment of Magnifying Endoscopy With Narrow Band Imaging Targeted Biopsy Compared With Endoscopic Forceps Biopsy From White Light Endoscopy

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2016
Registry last updated
Oct 2, 2025

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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