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A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study

NCT02930616 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-12

No results posted yet for this study

Summary

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.

Conditions

  • Gastric Intestinal Metaplasia
  • Confocal Laser Endomicroscopy
  • Operative Link on Gastric Intestinal Metaplasia
  • Biopsy

Interventions

DEVICE

Patients in Group 1 will receive pCLE at first and WLE 2 months later

DEVICE

patients in Group 2 will receive WLE at first and pCLE 2 months later.

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Li Yanqing, MD, PhD · Qilu Hospital of Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930616 on ClinicalTrials.gov