Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus (challenge)

This study has been completed.
Sponsor:
Collaborators:
American College of Gastroenterology
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01288612
First received: January 28, 2011
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

The hypothesis of this study was that the comparative effectiveness of unsedated transnasal endoscopy (uTNE) will be greater than sedated endoscopy (sEGD) in population screening for BE.


Condition Intervention
Barrett's Esophagus
Device: Sedated Endoscopy
Device: Transnasal Endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment [ Time Frame: Approximately 2 weeks after invitation letter was sent ] [ Designated as safety issue: No ]
    This outcome measure was defined as the proportion of subjects who agreed to undergo esophageal assessment in the three groups out of those who were eligible to be contacted for participation in screening.


Secondary Outcome Measures:
  • Rate of Successful Intubation [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    The rate of successful intubation was defined as the ability to traverse the upper esophageal sphincter and visualize the esophageal mucosa and classified as successful or unsuccessful.

  • Rate of Complete Evaluation [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    The rate of complete evaluation was defined as visualization of the whole esophagus and identification of landmarks: squamocolumnar junction, gastroesophageal junction (upper margin of gastric folds with stomach deflated), and the diaphragmatic hiatus. The categories of evaluation were classified as complete (all three landmarks identified), incomplete (some landmarks identified), or unsuccessful.

  • Rate of Acquisition of Biopsies From the Esophagus [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
  • Mean Duration of Procedure [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.

  • Mean Time From Extubation to Discharge [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
    This outcome measures the recovery time after the procedure.

  • Mean Tolerability Scores [ Time Frame: Day 1 after the procedure ] [ Designated as safety issue: No ]
    Validated pain scales (where 0 is none and 10 is severe) were used to assess the degree of pain, choking, gagging, and anxiety experienced during the procedure. Overall tolerance was rated on a scale from 0 to 10, where 0 is good, and 10 is poor tolerance.

  • Acceptability [ Time Frame: Day 1 after the procedure ] [ Designated as safety issue: No ]
    Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.


Enrollment: 459
Study Start Date: February 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sedated Endoscopy
Sedated esophagogastroduodenoscopy with biopsy
Device: Sedated Endoscopy
The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
Active Comparator: Transnasal Endoscopy at Hospital Unit
Unsedated transnasal endoscopy at hospital unit.
Device: Transnasal Endoscopy
Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
Active Comparator: Transnasal Endoscopy at Mobile Unit
Unsedated transnasal endoscopy in mobile research van
Device: Transnasal Endoscopy
Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.

Detailed Description:

Barrett's esophagus (BE), a well-known complication of Gastroesophageal Reflux (GER), is the strongest known precursor of esophageal adenocarcinoma. Thus, identifying effective screening approaches for the early detection of BE are highly desired. Current impediments to BE screening include 1) the inability to utilize sedated endoscopy (sEGD) effectively in populations and 2) current GER-based paradigms for detecting BE. Referral center studies demonstrate comparable accuracy between unsedated transnasal endoscopy (uTNE) and sEGD. However, patient acceptability and diagnostic yield with uTNE in general populations remain unknown.

Using the Rochester, Minnesota Epidemiology Project resources, random samples of Olmsted County residents were drawn, and those subjects were mailed validated gastrointestinal symptom questionnaires. These surveys allowed identification of a cohort of community subjects well characterized by the frequency of reflux symptoms. Eligible subjects who were greater than or equal to 50 years old, and who had no previous history of endoscopic evaluation and who were not known to have BE were randomized, stratified by age, sex, and reflux symptoms, and assigned to one of the 3 arms of the study. Subjects in each arm who met the eligibility criteria were initially sent generic invitation letters asking if they agreed to be contacted by phone in two weeks' time to inform them about a research study. If potential subjects explicitly declined to be contacted they were excluded from the study. Eligible subjects were contacted by telephone and only offered the endoscopy technique they had been randomized to. Subjects who accepted and signed an informed consent document were treated according to their randomized assignment and all 3 groups were followed up in the same manner.

Biopsies were taken from any endoscopically suspected BE and from the gastroesophageal junction and squamous mucosa in all subjects. The length of BE segment was defined using Prague criteria. All participants received a telephone call from the research coordinator 1 and 30 days after the procedure to complete validated tolerability scales and adverse events questionnaires.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Olmsted county, Minnesota resident
  • Age 50 or older
  • Able to give informed consent

Exclusion Criteria:

  • History of known Barretts Esophagus (BE) or endoscopy within the last 10 years
  • History of progressive dysphagia
  • Known Zenkers or epiphrenic diverticulum
  • History of recurrent epistaxis
  • Illnesses that impair ability to complete questionnaires (e.g. metastatic cancer, stroke, dementia)
  • Contraindication to esophageal biopsy (such as anticoagulation using warfarin or clopidogrel).
  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: NCT01288612

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
American College of Gastroenterology
Investigators
Principal Investigator: Prasad G. Iyer, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01288612     History of Changes
Other Study ID Numbers: 10-007787, RC4DK090413, UL1TR000135
Study First Received: January 28, 2011
Results First Received: December 23, 2014
Last Updated: December 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's Esophagus

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 23, 2015