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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508520
• Other study ID #: rjyyxhk6056
• Status: Completed
• Phase: N/A
• First received: January 8, 2012
• Last updated: January 11, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaobo Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	in 2 weeks after ME-NBI examination	No