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Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus (ETMI)

5. januar 2016 opdateret af: Louis-Michel Wong Kee Song, Mayo Clinic

Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study

This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus. This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.

Studieoversigt

Detaljeret beskrivelse

Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early adenocarcinoma (ACA) at a time when intervention can be curative. This approach, however, can be time-consuming and is hindered by low sampling yield and random sampling error. Endoscopic Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three advanced imaging features in one system: high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI). HRE and AFI provide a bird's-eye view of 'red flag' areas which are then assessed by NBI for focused and more specific tissue characterization. The aim of this prospective, multi-center study is to compare the diagnostic performance of ETMI with that of standard white-light endoscopy (WLE) for identifying high-grade dysplasia (HGD) and early adenocarcinoma (ACA) in BE. A total of 84 BE patients will be recruited for the study and they will undergo both ETMI and WLE examinations in a randomized, crossover fashion. Standard surveillance biopsies and ETMI-targeted biopsies will be performed. The primary outcome will compare the number of patients and lesions with HGD or early ACA detected with WLE and ETMI. It is anticipated that ETMI will enhance the detection of high-grade Barrett's lesions relative to WLE.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

60

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic
      • Amsterdam, Holland, 1105 AZ
        • Academic Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

patients with barrett's esophagus or esophageal cancer referred for endoscopy

Beskrivelse

Inclusion Criteria:

  1. Age > 18 years
  2. Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation
  3. Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according to the referring source
  4. A minimum Barrett's length of C>2M>2 or C<2M>4 according to the Prague C&M classification for the endoscopic appearance of BE
  5. Ability to provide written informed consent

Exclusion Criteria:

  1. Description of a visibly suspicious lesion within the Barrett's segment according to the referring source
  2. Presence of a type 0-I or type 0-III lesion, or a lesion that, according to the discretion of the endoscopist, does not allow delay in intervention for a period of 6 weeks (minimum interval between the two crossover endoscopies)
  3. Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (EMR)
  4. Presence of esophagitis > Los Angeles grade A classification
  5. Presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy)
  6. Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1
Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma
Endoscopy with biopsy 6 weeks after the initial endoscopy
Andre navne:
  • ETMI system (Olympus, Tokyo, Japan)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
1. The number of patients and the number of lesions with HGD or early ACA detected with WLE and ETMI 2. The number of patients with HGD and early ACA detected with targeted biopsies only with ETMI and WLE
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
1. The positive predictive value (PPV) of HRE and AFI 2. The reduction of false-positive findings after NBI (both the initial in vivo NBI assessment as well as later assessment based on still images)
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Louis M WongKeeSong, MD, Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2007

Primær færdiggørelse (Faktiske)

1. februar 2010

Studieafslutning (Faktiske)

1. september 2010

Datoer for studieregistrering

Først indsendt

21. december 2007

Først indsendt, der opfyldte QC-kriterier

4. januar 2008

Først opslået (Skøn)

7. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2016

Sidst verificeret

1. september 2010

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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