Management of Reflux After Sleeve Using Stretta

Brief Summary
Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.
Brief Title
Management of Reflux After Sleeve Using Stretta
Detailed Description
Gastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.

A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients \>18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.

The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.
Completion Date
Completion Date Type
Actual
Conditions
GERD
Morbid Obesity
Eligibility Criteria
Inclusion Criteria:

1. Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
2. On a PPI with GERD-related symptoms
3. On a PPI but like to discontinue them

Exclusion Criteria:

1. Age \<18 or \> 80
2. History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.
3. Unable or unwilling to consent for an invasive procedure.
4. History of intestinal leak after surgery.
5. History of revisional bariatric surgery
6. Significant sleeve abnormalities such and twist or large fundus
7. Hiatal hernia(\>2cm)
8. Pregnancy
9. Inability to comply with study protocols and procedures
10. Esophageal stricture, Eosinophilic Esophagitis or Achalasia
11. Prior esophageal surgery or therapy for Barrett's Esophagus
12. Grades 3 or 4 esophagitis
13. Gastric or esophageal varices
14. History of obstruction of the small bowel or inflammatory bowel disease
15. Pacemaker or implanted cardiac defibrillator
16. Coagulopathy or use of anticoagulants
17. ASA classification \>3
18. Scleroderma or other connective diseases
19. Use of immunosuppressive medications.
Inclusion Criteria
Inclusion Criteria:

1. Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
2. On a PPI with GERD-related symptoms
3. On a PPI but like to discontinue them

Gender
All
Gender Based
false
Keywords
GERD
sleeve gastrectomy
reflux
morbidly obese
Healthy Volunteers
No
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT02637713
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-5661a
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD
Primary Outcomes
Outcome Description
RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.
Outcome Measure
Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score
Outcome Time Frame
6 months
Outcome Description
RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.
Outcome Measure
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
Outcome Time Frame
12 months
Outcome Description
RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.
Outcome Measure
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
Outcome Time Frame
24 months
Outcome Description
GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.
Outcome Measure
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
Outcome Time Frame
6 months
Outcome Description
GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.
Outcome Measure
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
Outcome Time Frame
12 months
Outcome Description
GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.
Outcome Measure
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
Outcome Time Frame
24 months
Secondary Outcomes
Outcome Description
All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation.
Outcome Time Frame
Baseline
Outcome Measure
Esophageal pH Levels
Outcome Description
If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.
Outcome Time Frame
6 months
Outcome Measure
Esophageal pH Levels
Outcome Description
If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.
Outcome Time Frame
12 months
Outcome Measure
Esophageal pH Levels
Outcome Description
The number of patients using anti-reflux medications will be tabulated.
Outcome Time Frame
Baseline
Outcome Measure
Use of Anti-reflux Medication
Outcome Description
The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.
Outcome Time Frame
6 months
Outcome Measure
Cessation or Decreased Use of Anti-reflux Medication
Outcome Description
A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (\>50% retention at 4 hours) will be excluded from study
Outcome Time Frame
Baseline (up to 4 hours)
Outcome Measure
Gastric Emptying Study
Outcome Description
If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.
Outcome Time Frame
6 months
Outcome Measure
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
Outcome Description
If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy.
Outcome Time Frame
12 months
Outcome Measure
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
Outcome Description
An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology.
Outcome Time Frame
Baseline
Outcome Measure
EGD Abnormalities
Outcome Description
In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.
Outcome Time Frame
6 months
Outcome Measure
EGD Abnormalities
Outcome Description
In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined.
Outcome Time Frame
12 months
Outcome Measure
EGD Abnormalities
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Erin Moran-Atkin
Investigator Email
emorana@montefiore.org
Investigator Phone