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Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

Primary Purpose

Early Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ME-NBI observation and ME-NBI targeted biopsy

About this trial

This is an interventional diagnostic trial for Early Gastric Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 during last white light endoscopy
they couldn't tolerate another endoscopic examination

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected EGC group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Positive predictive value (PPV) 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, PPV of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated.

Negative predictive value (NPV) 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, NPV of EFB, ME-NBI, ME-NBI targeted biopsy, ME-NBI combined EFB and ME-NBI combined targeted biopsy was calculated.

Full Information

NCT ID

NCT02738294

First Posted

March 8, 2016

Last Updated

April 13, 2016

Sponsor

Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02738294

Brief Title

Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Gastric Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suspected EGC group

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ME-NBI observation and ME-NBI targeted biopsy

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

30 months

Title

Sensitivity in distinguishing HGN from non-HGN

Description

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.

Time Frame

30 months

Title

Specificity in distinguishing HGN from non-HGN

Description

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.

Time Frame

30 months

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

30 months

Title

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

Description

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.

Time Frame

30 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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 during last white light endoscopy they couldn't tolerate another endoscopic examination

Facility Information:

Facility Name

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

City

Shanghai

ZIP/Postal Code

200001

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

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