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

• ClinicalTrials.gov Identifier: NCT01288612
• Recruitment Status: Completed
• First Posted: February 2, 2011
• Results First Posted: January 7, 2015
• Last Update Posted: January 7, 2015
• Sponsor: Mayo Clinic
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Center for Advancing Translational Science (NCATS); American College of Gastroenterology
• Information provided by (Responsible Party): Prasad G. Iyer, Mayo Clinic

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Barrett's Esophagus	Device: Sedated Endoscopy; Device: Transnasal Endoscopy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 459 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comparative Effectiveness of Endoscopic Assessment of Gastroesophageal Reflux and Barretts Esophagus
• Study Start Date: February 2011
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects Who Agreed to Participated in the Esophageal Assessment [ Time Frame: Approximately 2 weeks after invitation letter was sent ]
   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 :

1. Rate of Successful Intubation [ Time Frame: Visit 1 ]
   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.
2. Rate of Complete Evaluation [ Time Frame: Visit 1 ]
   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.
3. Rate of Acquisition of Biopsies From the Esophagus [ Time Frame: Visit 1 ]
4. Mean Duration of Procedure [ Time Frame: Visit 1 ]
   Duration of the procedure was defined as time from the beginning of the procedure (initiation of sedation or local anesthesia) to extubation.
5. Mean Time From Extubation to Discharge [ Time Frame: Visit 1 ]
   This outcome measures the recovery time after the procedure.
6. Mean Tolerability Scores [ Time Frame: Day 1 after the procedure ]
   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.
7. Acceptability [ Time Frame: Day 1 after the procedure ]
   Acceptability was defined as the proportion of subjects willing to undergo the procedure again in the future.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 95 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Center for Advancing Translational Science (NCATS)

American College of Gastroenterology

Investigators

• Principal Investigator: Prasad G. Iyer, MD; Mayo Clinic

More Information

Publications of Results:

Sami SS, Dunagan KT, Johnson ML, Schleck CD, Shah ND, Zinsmeister AR, Wongkeesong LM, Wang KK, Katzka DA, Ragunath K, Iyer PG. A randomized comparative effectiveness trial of novel endoscopic techniques and approaches for Barrett's esophagus screening in the community. Am J Gastroenterol. 2015 Jan;110(1):148-58. doi: 10.1038/ajg.2014.362. Epub 2014 Dec 9.

• Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01288612
• Other Study ID Numbers: 10-007787; RC4DK090413 ( U.S. NIH Grant/Contract ); UL1TR000135 ( U.S. NIH Grant/Contract )
• First Posted: February 2, 2011
• Results First Posted: January 7, 2015
• Last Update Posted: January 7, 2015
• Last Verified: December 2014

Keywords provided by Prasad G. Iyer, Mayo Clinic:

Barrett's Esophagus

Additional relevant MeSH terms:

Barrett Esophagus; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms