Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

NCT02738294 | Completed DMC

• 1 other identifier: rjxhnk[2013]113
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Gastric Cancer

Outcome Measures

Primary Outcomes (3)

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

  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.

  30 months

• Sensitivity in distinguishing HGN from non-HGN

  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.

  30 months

• Specificity in distinguishing HGN from non-HGN

  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.

  30 months

Secondary Outcomes (2)

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

  30 months

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

  30 months

Study Arms (1)

Suspected EGC group

EXPERIMENTAL

Participants with suspected EGC from white light endoscopy were enrolled.The endoscopist first used white light endoscopy to identify suspected gastric lesions and assessed lesions carefully with magnifying view, non-magnifying NBI view and ME-NBI view in sequence. After assessing suspected EGC in ME-NBI view, ME-NBI targeted biopsy was performed where abnormal phenomenon was identified in ME-NBI view.

Device: ME-NBI observation and ME-NBI targeted biopsy

Interventions

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.

Suspected EGC group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, 200001, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.Ph.D

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 14, 2016
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 2, 2025

Record last verified: 2016-03

Locations

CN (1)