Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia

NCT03672708 | Completed DMC

• 1 other identifier: 2018SDU-QILU-06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye

Conditions

Gastric Intestinal Metaplasia

Outcome Measures

Primary Outcomes (4)

• feasibility of CV for identifying GIM

  ratio of pCLE failure to visualize the cellular and subcellular structures

  1 month

• feasibility of CV for identifying GIM

  ratio of pCLE failure to recognize lesions and their immediate characterization

  1 month

• newly pCLE criteria with CV application for GIM

  ratio of diagnostic agreement between pCLE using CV and histopathological results

  1 month

• newly pCLE criteria with CV application for GIM

  number of diagnostic agreement between pCLE with CV application and histopathological results

  1 month

Study Arms (1)

Cresyl violet

OTHER

Diagnostic Test: Cresyl violet

Interventions

Cresyl violet DIAGNOSTIC_TEST

cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE

Cresyl violet

Eligibility Criteria

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

You may qualify if:

• patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
• patients with H. pylori infection, or known GIM or atrophic gastritis

You may not qualify if:

• patients with a history of GI surgery
• advanced gastric carcinoma or any other malignancy in the GI tract
• acute upper GI bleeding
• patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
• patients refused to provide informed consent

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

• Yanqing Li, PhD,MD

  Department of Gastroenterology,Qilu Hospital,shandong University

  STUDY DIRECTOR

• Zhen Li, PhD,MD

  Department of Gastroenterology,Qilu Hospital,shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of Qilu Hospital

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: September 14, 2018
• Study Start: September 16, 2018
• Primary Completion: October 26, 2018
• Study Completion: January 2, 2019
• Last Updated: May 14, 2019

Record last verified: 2018-09

Locations

CN (1)