Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy
NCT ID: NCT01398579
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2011-09-30
2012-09-30
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Group A
Group A: WLE followed by AFI followed by NBI followed by pCLE.
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.
Group B
Group B: WLE followed by NBI followed by AFI followed by pCLE.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
90 Years
ALL
No
Sponsors
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National Medical Research Council (NMRC), Singapore
OTHER_GOV
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Khek Yu Ho, Prof
Role: PRINCIPAL_INVESTIGATOR
NUHS
Locations
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National University Hospital
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Facility Contacts
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Lee Guan Lim, Doctor
Role: primary
References
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Uedo N, Ishihara R, Iishi H, Yamamoto S, Yamamoto S, Yamada T, Imanaka K, Takeuchi Y, Higashino K, Ishiguro S, Tatsuta M. A new method of diagnosing gastric intestinal metaplasia: narrow-band imaging with magnifying endoscopy. Endoscopy. 2006 Aug;38(8):819-24. doi: 10.1055/s-2006-944632.
Eisen GM, Baron TH, Dominitz JA, Faigel DO, Goldstein JL, Johanson JF, Mallery JS, Raddawi HM, Vargo JJ 2nd, Waring JP, Fanelli RD, Wheeler-Harbough J; American Society for Gastrointestinal Endoscopy. Complications of upper GI endoscopy. Gastrointest Endosc. 2002 Jun;55(7):784-93. doi: 10.1016/s0016-5107(02)70404-5.
Pohl H, Rosch T, Vieth M, Koch M, Becker V, Anders M, Khalifa AC, Meining A. Miniprobe confocal laser microscopy for the detection of invisible neoplasia in patients with Barrett's oesophagus. Gut. 2008 Dec;57(12):1648-53. doi: 10.1136/gut.2008.157461. Epub 2008 Aug 28.
Buchner AM, Shahid MW, Heckman MG, Krishna M, Ghabril M, Hasan M, Crook JE, Gomez V, Raimondo M, Woodward T, Wolfsen HC, Wallace MB. Comparison of probe-based confocal laser endomicroscopy with virtual chromoendoscopy for classification of colon polyps. Gastroenterology. 2010 Mar;138(3):834-42. doi: 10.1053/j.gastro.2009.10.053. Epub 2009 Nov 10.
Inoue T, Uedo N, Ishihara R, Kawaguchi T, Kawada N, Chatani R, Kizu T, Tamai C, Takeuchi Y, Higashino K, Iishi H, Tatsuta M, Tomita Y, Toth E. Autofluorescence imaging videoendoscopy in the diagnosis of chronic atrophic fundal gastritis. J Gastroenterol. 2010;45(1):45-51. doi: 10.1007/s00535-009-0150-7. Epub 2009 Oct 30.
Kato M, Kaise M, Yonezawa J, Yoshida Y, Tajiri H. Autofluorescence endoscopy versus conventional white light endoscopy for the detection of superficial gastric neoplasia: a prospective comparative study. Endoscopy. 2007 Nov;39(11):937-41. doi: 10.1055/s-2007-966857.
Ezoe Y, Muto M, Horimatsu T, Minashi K, Yano T, Sano Y, Chiba T, Ohtsu A. Magnifying narrow-band imaging versus magnifying white-light imaging for the differential diagnosis of gastric small depressive lesions: a prospective study. Gastrointest Endosc. 2010 Mar;71(3):477-84. doi: 10.1016/j.gie.2009.10.036.
Yao K, Iwashita A, Tanabe H, Nishimata N, Nagahama T, Maki S, Takaki Y, Hirai F, Hisabe T, Nishimura T, Matsui T. White opaque substance within superficial elevated gastric neoplasia as visualized by magnification endoscopy with narrow-band imaging: a new optical sign for differentiating between adenoma and carcinoma. Gastrointest Endosc. 2008 Sep;68(3):574-80. doi: 10.1016/j.gie.2008.04.011. Epub 2008 Jul 26.
Kato M, Kaise M, Yonezawa J, Goda K, Toyoizumi H, Yoshimura N, Yoshida Y, Kawamura M, Tajiri H. Trimodal imaging endoscopy may improve diagnostic accuracy of early gastric neoplasia: a feasibility study. Gastrointest Endosc. 2009 Nov;70(5):899-906. doi: 10.1016/j.gie.2009.03.1171.
Wallace MB, Meining A, Canto MI, Fockens P, Miehlke S, Roesch T, Lightdale CJ, Pohl H, Carr-Locke D, Lohr M, Coron E, Filoche B, Giovannini M, Moreau J, Schmidt C, Kiesslich R. The safety of intravenous fluorescein for confocal laser endomicroscopy in the gastrointestinal tract. Aliment Pharmacol Ther. 2010 Mar;31(5):548-52. doi: 10.1111/j.1365-2036.2009.04207.x. Epub 2009 Nov 30.
Lim LG, Yeoh KG, Srivastava S, Chan YH, Teh M, Ho KY. Comparison of probe-based confocal endomicroscopy with virtual chromoendoscopy and white-light endoscopy for diagnosis of gastric intestinal metaplasia. Surg Endosc. 2013 Dec;27(12):4649-55. doi: 10.1007/s00464-013-3098-x. Epub 2013 Jul 27.
Other Identifiers
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E\10\703
Identifier Type: -
Identifier Source: org_study_id