Clinical trial · Interventional
Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB
Necessity Assessment of Magnifying Endoscopy With Narrow Band Imaging Targeted Biopsy Compared With Endoscopic Forceps Biopsy From White Light Endoscopy
NCT02738294CI-TRIAL-00096132completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ME-NBI observation and ME-NBI targeted biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Suspected EGC 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.
- interventionNames
- Device: ME-NBI observation and ME-NBI targeted biopsy
Primary outcomes (3)
- measure
- Accuracy in distinguishing high-grade neoplasia (HGN) from non-HGN
- timeFrame
- 30 months
- 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. 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.