Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery (EGScan)
Primary Purpose
Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
clinic-based nasopharyngoendoscopy
Standard Endoscopy
Sponsored by

About this trial
This is an interventional diagnostic trial for Obesity focused on measuring Obesity, Endoscopy, Nasopharyngoesophagogastroscopy, Bariatric Surgery, Gastric Bypass Surgery
Eligibility Criteria
Inclusion Criteria:
- Post-operative gastric bypass patients at St. Joseph's Healthcare Hamilton
- No previous nasal or pharyngeal surgery
- Foregut dyspeptic symptoms including: nausea, vomiting, regurgitation, epigastric pain, reflux and/or hematemesis
- Require endoscopy for investigation of foregut symptoms
- Able to provide consent
Exclusion Criteria:
- Patients who have not undergone gastric bypass surgery
- Inability to give consent
Sites / Locations
- St. Joseph's Healthcare Hamilton
Outcomes
Primary Outcome Measures
Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients.
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Secondary Outcome Measures
Complications of standard and in-office transnasal esophagoscopy
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
How well patients tolerate in-office transnasal esophagoscopy
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Full Information
NCT ID
NCT01602991
First Posted
May 7, 2012
Last Updated
September 22, 2015
Sponsor
Dennis Hong MD
Collaborators
Vantage Endoscopy
1. Study Identification
Unique Protocol Identification Number
NCT01602991
Brief Title
Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
Acronym
EGScan
Official Title
Sensitivity, Specificity, and Positive and Negative Predictive Values of Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
difficulty obtaining funding
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dennis Hong MD
Collaborators
Vantage Endoscopy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to determine that this new technology, nasopharyngoendoscopy, is just as effective in diagnosing problems as the current gold standard.
Detailed Description
Obesity is a public health problem. Currently, the best treatment is surgery. However, 15% of patients after surgery have problems such as nausea, pain, vomiting, heartburn or regurgitation. To investigate these problems, an endoscopy is used. Yet, endoscopy has some disadvantages such as the need for intravenous sedation, need to take time off work, need for special endoscopy units and nurses and a delay in diagnosing because the endoscopy cannot be done at the time of the clinic visit. A new technology called clinic-based nasopharyngoendoscopy can potentially solve many of the problems with the current endoscopy. This study aims to determine that this new technology is just as effective in diagnosing problems as the current gold standard.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Endoscopy, Nasopharyngoesophagogastroscopy, Bariatric Surgery, Gastric Bypass Surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
clinic-based nasopharyngoendoscopy
Other Intervention Name(s)
E.G. Scan
Intervention Description
The study intervention is an in-office transnasal esophagoscopy. It is done in clinic, immediately after deciding the patient requires investigation of their upper gastrointestinal tract and the patient signs consent. The nasopharynx and oral pharynx is topically anesthetized. Since flexible scope is much thinner than a standard endoscopy, there is no requirement for intravenous sedation and thus, no requirement for specialized monitoring, nursing or recovery units. The procedure takes approximately 10 minutes. This study will be using the E.G. Scan II System.
Intervention Type
Procedure
Intervention Name(s)
Standard Endoscopy
Intervention Description
The control procedure is standard endoscopy. Endoscopy will be performed as per standard clinic practice. It is typically scheduled within 2 weeks of seeing the patient in clinic. The patient will be required to fast for 6 hours prior to the procedure. In most cases, patients will require intravenous sedation. If sedation is used, the patient will be required to take the day off work and have someone drive them home. This is the standard treatment for patients who present with upper gastrointestinal symptoms post-bariatric surgery. Patients who choose not to participate in this study will still undergo endoscopy as per standard clinical practice.
Primary Outcome Measure Information:
Title
Sensitivity, specificity, and positive and negative predictive values of in-office transnasal esophagoscopy in evaluating symptomatic, post-operative bariatric surgery patients.
Description
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Time Frame
Approximately 8 weeks
Secondary Outcome Measure Information:
Title
Complications of standard and in-office transnasal esophagoscopy
Description
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Time Frame
approximately 8 weeks
Title
Differences in in-hospital resource use between standard endoscopy and office-based transnasal nasopharyngoendoscopy
Description
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Time Frame
Approximately 8 weeks
Title
How well patients tolerate in-office transnasal esophagoscopy
Description
The patients will receive transnasal esophagoscopy, then standard endoscopy approximately 2 weeks later. Patients will return to the bariatric clinic 2-4 weeks after standard endoscopy to review the results of both procedures and discuss possible treatment. Patients will not be required to undergo any further study-related follow-up or complete any questionnaires.
Time Frame
Immediately following transnasal esophagoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post-operative gastric bypass patients at St. Joseph's Healthcare Hamilton
No previous nasal or pharyngeal surgery
Foregut dyspeptic symptoms including: nausea, vomiting, regurgitation, epigastric pain, reflux and/or hematemesis
Require endoscopy for investigation of foregut symptoms
Able to provide consent
Exclusion Criteria:
Patients who have not undergone gastric bypass surgery
Inability to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Hong, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinic-based Nasopharyngoesophagogastroscopy Following Bariatric Surgery
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