Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy (pCLE-GCEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01398579
First received: June 26, 2011
Last updated: July 10, 2012
Last verified: August 2011
  Purpose

The investigators hypothesis that

  1. clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable
  2. pCLE, as compared to white-light endoscopy (WLE), AFI and magnifying NBI has higher sensitivity and specificity for the diagnosing gastric pre-neoplastic and neoplastic lesions

Condition Intervention Phase
Intestinal Metaplasia
Intestinal Dysplasia
Procedure: Gastroscopy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prospective Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy for the Diagnosis of Gastric Pre-neoplastic and Neoplastic Lesions (pCLE-GCEP)

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis [ Time Frame: An average of 1 week for which histology report will be out for comparison ] [ Designated as safety issue: No ]
    For each patient, the minimum sites of pCLE examination must consist of 2 sites at antrum, 1 site at the incisura, 2 sites at the corpus, and 1 site at the cardia. When suspicious lesions are present, more sites of pCLE examination will be allowed. Each site of pCLE examination will be biopsied and sent for histology.The pCLE examination will be video recorded and interpretation will be done independently on a separate day from the endoscopy day.The analysis will be by per biopsy site matched with corresponding video sequence


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Group A: WLE followed by AFI followed by NBI followed by pCLE.
Procedure: Gastroscopy

20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B.

Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE.

Other Name: OGD
Active Comparator: Group B
Group B: WLE followed by NBI followed by AFI followed by pCLE.
Procedure: Gastroscopy

20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B.

Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE.

Other Name: OGD

Detailed Description:

Patients will be recruited from an ongoing study - Gastric Cancer Epidemiology, Clinical and Genetic Programme Cohort Study (GCEP). GCEP is a prospective cohort study aiming to enroll 3,000 Singapore- Chinese subjects aged >50 years, and offers screening by endoscopy and systematic follow-up for a minimum of 5 years. 20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B. Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE. The difference between two groups is the sequence of two endoscopy imaging modes - AFI and NBI. Diagnosis made during NBI and AFI must be made based on pre-defined criteria, and should not be influenced by the preceding imaging modality. To control for the possible bias on the third imaging modality caused by influence from the preceding imaging modality, patients are randomized to receive NBI before AFI or AFI before NBI.

Endoscopic diagnosis will be made for each suspected lesion with every imaging modality. The biopsy of lesions will be taken after pCLE examination is completed and sent for histology. In the absence of suspicious lesions, the area of examination will be as follows (as stated in main GCEP protocol):

  • A1- lesser curvature of the antrum, within 2-3cm of the pylorus.
  • A2- greater curvature of the antrum, within 2-3cm of the pylorus.
  • IA- incisura angularis.
  • B1- lesser curvature of the corpus, 4cm proximal to the angulus.
  • B2- middle portion of the greater curvature of the corpus, 8cm from the cardia.
  • Cardia (C) - within 1 cm below the OGJ (defined as the point where gastric folds disappear).

The results will be compared with the gold standard diagnosis - histopathology diagnosis. The sensitivity and specificity for each imaging tool will be calculated accordingly.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is Chinese
  • The subject is greater than 50 years of age
  • The subject satisfies one or more of the following criteria:

    • has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms include bloating, epigastric discomfort and early satiety
    • has a family history of gastric cancer
    • has a medical condition for which an OGD is indicated.
  • Has past history of intestinal metaplasia or dysplasia
  • The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
  • The subject must be willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

  • patients who cannot undergo gastroscopies
  • have a personal history of stomach cancer or surgery
  • any disabling illnesses
  • are pregnant or breast-feeding
  • have bronchial asthma or a known allergy to fluorescein
  • have renal impairment with serum creatinine above the upper limit of normal
  • have uncorrected coagulopathy or severe thrombocytopenia precluding biopsy
  • unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398579

Contacts
Contact: Lee Guan Lim 67795555 lee_guan_lim@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119974
Contact: Lee Guan Lim, Doctor    67795555    lee_guan_lim@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: Khek Yu Ho, Prof NUHS
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01398579     History of Changes
Other Study ID Numbers: E\10\703
Study First Received: June 26, 2011
Last Updated: July 10, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
intestinal metaplasia
dysplasia
probe-based confocal endomicroscopy

Additional relevant MeSH terms:
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014