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CompletedNCT01508520Updated Jan 12, 2012

a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

An observational study in Stomach Neoplasms, sponsored by Xiaobo Li. Completed. Per ClinicalTrials.gov, last updated 2012-01-12.

Sponsored by Xiaobo Li · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
146
Sex
All
01

Study summary

Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:

  1. ME-NBI is useful in distinguishing EGC from other gastric lesions
  2. ME-NBI is useful in further differential diagnosis among EGCs.
02

Conditions studied

  • Stomach Neoplasms

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Keywords

  • early gastric cancer
  • stomach neoplasms
  • magnifying endoscopy
  • narrow band imaging
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 146 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Xiaobo Li is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with gastric lesions suspected of early gastric malignancy

Inclusion criteria

  • patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.

Exclusion criteria

Exclusion Criteria:

  • advanced gastric cancer or any other malignancy;
  • patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
  • inability to provide informed consent;
  • inability to provide histology of resected specimens after endoscopic treatment or surgery.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
146 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. diagnosis accuracy of ME-NBI

    ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.

    Time frame: in 2 weeks after ME-NBI examination

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01508520
Lead sponsor
Xiaobo Li
Responsible party
Xiaobo Li (Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Jan 12, 2012
Start date
Dec 2009
Primary completion
Oct 2011
Completion
Dec 2011
Last update
Jan 12, 2012

Study contacts

Xiaobo Li, MD. Ph.D
principal investigator · Shanghai Ren Ji Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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