Endoscopic Detection of Dysplasia in Barrett's Esophagus

This study has been completed.
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01694511
First received: September 17, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine whether High Resolution Magnification Endoscopy (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with Barrett's Esophagus (BE).


Condition Intervention
Barrett's Esophagus
Procedure: HRME+CVC
Procedure: conventional endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: High Resolution Magnifying Endoscopy and Contrast Enhanced Imaging Versus Standard White Light Endoscopy for the Detection of Dysplasia in Barrett's Esophagus. A Prospective Blinded Cross-over Study.

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Incidence of detected dysplasia by each endoscopic technique. [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The yield of low- and/or high-grade dysplasia by each endoscopic technique. [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]
  • The number of biopsies taken and the duration of the different endoscopic techniques. [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The endoscopic prediction capability of present dysplasia compared to histopathology for HRME. [ Time Frame: Up to 36 months. ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: November 2009
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Introductory conventional endoscopy
Conventional endoscopy followed by HRME+CVC after 30 days.
Procedure: HRME+CVC
High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy
Active Comparator: Introductory HRME+CVC
HRME+CVC followed by conventional endoscopy after 30 days.
Procedure: conventional endoscopy
Conventional white light endoscopy with four-quadrant biopsy

Detailed Description:

BE is a metaplastic mucosal transformation adjacent to the esophagogastric junction, due to chronic reflux of gastric juices, Gastro Esophageal Reflux Disease (GERD). The continuous esophageal exposure of acid- and/or bile- containing fluids leads, untreated, to chronic esophagitis. In certain patients a mucosal transformation takes place. The epithelium in the distal part of esophagus is transferred from squamous into a more intestinal-like mucosa, called Specialized Intestinal Metaplasia (SIM).Patients with BE is believed to run a higher risk of developing esophageal adenocarcinoma (EAC).

EAC is a rare condition in the western society, but the prevalence is rising compared with other malignancies, and a substantial increase has been seen during the last four decades. The pathogenesis of cancer development is believed to be that SIM in some patients can undergo dysplastic transformation, from low to high grade, and from high grade dysplasia (HGD) develop into AC. Advanced EAC is associated to a poor prognosis whereas HGD or carcinoma in situ may be treated endoscopically with a favorable outcome.

The need for surveillance endoscopy in order to discover early cancer lesions available to curable treatment is up against cost effectiveness and evidence level regarding screening. The conventional endoscopic (CE) surveillance algorithm for BE is standard WLE and 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm above the esophagogastric junction. The development of advanced endoscopic techniques have made it possible to distinguish minimal polypoid lesions but also the microvasculature and pit-pattern structures that in certain grading systems have been associated to presence of dysplasia. Attempts have been made in exploring the benefits of advanced endoscopic technologies against standard WLE. Feasibility-studies suggests that the new techniques improves the biopsy-yield for dysplasia, however only a limited number of prospective studies exist.

Study aim: To determine whether HRME and CVC with targeted biopsies is superior to conventional WLE with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with BE.

Primary endpoint: Incidence of detected dysplasia by each endoscopic technique. Secondary endpoints: 1.The yield of low- and/or high-grade dysplasia by each endoscopic technique. 2.The number of biopsies taken and the duration of the different endoscopic techniques. 3.The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.

Statistical power: Based on the primary endpoint, the amount of dysplasia in a Barrett-population is approximately 10%. We calculated a raise in positive yield with using advanced endoscopy to 8%. At p<0,05 and a power of 80% the need for 105 patients.

Setting: Tertiary referral high volume endoscopy center at Sahlgrenska University Hospital, Sweden.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of specialized intestinal metaplasia in biopsies from the esophagus

Exclusion Criteria:

  • Dysplasia or cancer
  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: NCT01694511

Locations
Sweden
Gastrointestinal Endoscopy Unit, Sahlgrenska University Hospital
Gothenburg, Sweden, S-41345
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
Study Director: Anders F Edebo, MD, PhD Dept. Gastrosurgical Research and Education, Inst. Clinical Sciences, Sahlgrenska Academy, Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01694511     History of Changes
Other Study ID Numbers: 2-2188
Study First Received: September 17, 2012
Last Updated: February 7, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Endoscopy, Gastrointestinal

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014