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 | Unknown Phase 4 DMC

• 1 other identifier: 2016SDU-QILU-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.

  9 months

• the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.

  9 months

Secondary Outcomes (2)

• the overall detection rate of GIM by pCLE.

  9 months

• the overall detection rate of GIM by WLE.

  9 months

Study Arms (2)

group 1

EXPERIMENTAL

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

goup 2

ACTIVE COMPARATOR

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.

Interventions

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

group 1

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

goup 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

• Li Yanqing, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)