Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Early Gastric Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02738294

rjxhnk[2013]113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Volunteers: No 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 or more than 2 biopsies were performed on suspected gastric lesions during last white light endoscopy
• they couldn't tolerate another endoscopic examination

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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211 participants in 1 patient group

Suspected EGC group

Experimental group

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.

Treatment:

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