A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass

A Prospective Study Evaluating The Utility of Transnasal Endoscopy With Roux en Y Gastric Bypass Referred for Upper Endoscopy

Improvements in imaging technology have allowed for the development of small endoscopes ("slim scopes") half the size of a typical endoscope. These small endoscopes can be passed transnasally into the esophagus and stomach with only local anesthesia to the nasal passage without the need for deep sedation. They have been used in the detection of diseases of the esophagus and stomach,3,4 but have not been used in the detection of complications in the post bariatric population

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Procedure: Endoscopy

Detailed Description

Obesity is an epidemic in the United States effecting 250 million people worldwide and over 30% of the population of the United Sates. Medical therapy for obesity is lacking in its durability in maintaining weight loss. Currently surgical therapy is the most dependable and durable treatment option. The Roux en Y gastric bypass (RYGB) was initially described in 1967 and is currently the surgical method of choice in the treatment of obesity. It involves the creation of a small gastric pouch by restricting the gastric body and antrum and the creation of a long roux limb with a gastrojejunal anastomosis, thus inducing satiety and creating a malabsorptive physiology. Unfortunately this procedure maintains a significant complication rate. Strictures at the gastrojejunal anastomosis occur in 6-20% of patients after bypass.1 Anastomotic ulcers occur in up to 16% .2 Symptoms include vomiting, abdominal pain, and significant nausea. Unfortunately these symptoms are not specific to strictures or ulcers and may occur spontaneously without a specific etiology, so often a transoral upper endoscopy (EGD) is required to evaluate the anastomosis for significant pathology.

EGD in post bariatric patients is a safe procedure. However it typically requires deep sedation administered by an anesthesiologist to overcome the patient's gag reflex and discomfort. Sedation in obese patients can be challenging due to the risks of apnea and challenges of tracheal intubation. For the procedure to be performed the patient must take the day off from work and bring a driver to take them home, thus there are significant direct and indirect costs to the procedure.

Improvements in imaging technology have allowed for the development of small endoscopes ("slim scopes") half the size of a typical endoscope. These small endoscopes can be passed transnasally into the esophagus and stomach with only local anesthesia to the nasal passage without the need for deep sedation. They have been used in the detection of diseases of the esophagus and stomach,3,4 but have not been used in the detection of complications in the post bariatric population

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This pilot study will attempt to recruit 20 subjects over one year.

Description

Inclusion Criteria:

• Subjects must be able to review and sign informed consent
• Subjects have undergone Roux en Y gastric bypass
• Subjects report any of the following symptoms that would prompt investigation and referral for an upper endoscopy; abdominal pain, nausea, vomiting or problems swallowing

Exclusion Criteria:

• Patients who cannot give and sign informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who have undergone RYGB; Patients who have undergone RYGB and have been referred for an EGD	Procedure: Endoscopy; Transoral endoscopy versus transoral endoscopy; Other Names: Endoscopy performed transnasally with a slim scope; Transoral endoscopy with a routine diagnostic endoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic ulcer and diameter	Presence of anastomic ulcer seen by slim scope	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of anastomotic stricture and diameter	Presence of anastomotic sticture seen by slim scope and estimated anastomis diameter	1 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: John O Evans, MD, Wake Forest University Baptist Health

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 7, 2014
• Study Completion (Actual): July 7, 2014

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: February 1, 2012
• First Posted (Estimate): February 6, 2012

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Upper Endoscopy; Transnasal; Transoral; Roux en Y gastric bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: IRB00018487