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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

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ClinicalTrials.gov Identifier: NCT02930616
Recruitment Status : Unknown
Verified October 2016 by Yanqing Li, Shandong University.
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2016
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Intestinal Metaplasia Confocal Laser Endomicroscopy Operative Link on Gastric Intestinal Metaplasia Biopsy 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. Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: group 1
Patients in Group 1 will receive probe-based confocal endomicroscopy (pCLE) at first and Wight light endoscopy (WLE) 2 months later
Device: Patients in Group 1 will receive pCLE at first and WLE 2 months later
Active Comparator: goup 2
patients in Group 2 will receive WLE at first and pCLE 2 months later.
Device: patients in Group 2 will receive WLE at first and pCLE 2 months later.



Primary Outcome Measures :
  1. the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE. [ Time Frame: 9 months ]
  2. the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. the overall detection rate of GIM by pCLE. [ Time Frame: 9 months ]
  2. the overall detection rate of GIM by WLE. [ Time Frame: 9 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 40 years or older with Helicobacter pylori infection;
  • Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
  • Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
  • Pregnancy or breastfeeding;
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930616


Contacts
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Contact: Li Yanqing, MD, PhD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Not yet recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD    86-531-82169236    liyanqing@sdu.edu.cn   
Contact: Yanqing Li, MD, PhD    86-0531-82169236    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Li Yanqing, MD, PhD Qilu Hospital of Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02930616     History of Changes
Other Study ID Numbers: 2016SDU-QILU-17
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Metaplasia
Pathologic Processes