Comparison Between Probe-based Confocal Laser Endomicroscopy, White-light Endoscopy and Virtual Chromoendoscopy

NCT01398579 | Unknown Phase 1

• 1 other identifier: E\10\703
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesis that

1. 1.clinical applicability and overall diagnostic sensitivity and specificity of pCLE for diagnosing gastric preneoplastic and neoplastic lesions is acceptable
2. 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

Conditions

Intestinal Metaplasia; Intestinal Dysplasia

Keywords

intestinal metaplasia; dysplasia; probe-based confocal endomicroscopy

Outcome Measures

Primary Outcomes (1)

• Percentage of accurate endoscopic diagnosis made with pCLE compared with histopathology diagnosis

  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

  An average of 1 week for which histology report will be out for comparison

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Procedure: Gastroscopy

Group B

ACTIVE COMPARATOR

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

Procedure: Gastroscopy

Interventions

Gastroscopy PROCEDURE

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.

Also known as: OGD

Group A; Group B

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119974, Singapore

RECRUITING

Related Publications (11)

• 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.

  PMID: 17001572 BACKGROUND

• 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.

  PMID: 12024128 BACKGROUND

• 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.

  PMID: 18755886 RESULT

• 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.

  PMID: 19909747 RESULT

• 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.

  PMID: 19876586 RESULT

• 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.

  PMID: 18008201 RESULT

• 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.

  PMID: 20189506 RESULT

• 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.

  PMID: 18656862 RESULT

• 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.

  PMID: 19595318 RESULT

• 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.

  PMID: 20002025 RESULT

• 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.

  PMID: 23892761 DERIVED

MeSH Terms

Interventions

Gastroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Khek Yu Ho, Prof

  NUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Guan Lim

CONTACT

67795555; lee_guan_lim@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2011
• First Posted: July 20, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2011-08

Locations

SG (1)