GERD, Morbid Obesity
Conditions
Keywords
GERD, sleeve gastrectomy, reflux, morbidly obese
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.
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.
Interventions
DEVICEStretta
Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.
PROCEDURERadiofrequency (RF) Energy to the LES (Stretta Procedure)
The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score | 6 months | 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. |
| Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score | 12 months | 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. |
| Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Emptying Study | Baseline (up to 4 hours) | 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 |
| Esophageal pH Levels | Baseline | 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. |
| EGD Abnormalities | Baseline | 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. |
| Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy | 6 months | 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. |
| Use of Anti-reflux Medication | Baseline | The number of patients using anti-reflux medications will be tabulated. |
| Cessation or Decreased Use of Anti-reflux Medication | 6 months | The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Energy to the Lower Esophageal Sphincter (LES) All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms.
Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.
Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 2 |
Baseline characteristics
| Characteristic | Radiofrequency Energy to the Lower Esophageal Sphincter (LES) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race/Ethnicity, Customized Black or African-American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 2 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
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.
Time frame: 6 months
Population: Study was terminated early and no 6 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.
Primary
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
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.
Time frame: 12 months
Population: Study was terminated early and no 12 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.
Primary
Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score
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.
Time frame: 24 months
Population: Study was terminated early and no 24 month GERD-HRQL data were collected. As such, there were no results to aggregate and report.
Primary
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
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.
Time frame: 12 months
Population: Study was terminated early and no 12 month RSI data were collected. As such, there were no RSI scores to aggregate and report.
Primary
Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score
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.
Time frame: 24 months
Population: Study was terminated early and no 24 month RSI data were collected. As such, there were no RSI scores to aggregate and report.
Primary
Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score
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.
Time frame: 6 months
Population: Study was terminated early and no 6 month RSI data were collected. As such, there were no RSI scores to aggregate and report.
Secondary
Cessation or Decreased Use of Anti-reflux Medication
The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated.
Time frame: 6 months
Population: Study was terminated early and data related to the cessation or decreased use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report.
Secondary
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
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.
Time frame: 12 months
Population: Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 12 month gastric dysmotility results to aggregate and report.
Secondary
Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy
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.
Time frame: 6 months
Population: Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 6 month gastric dysmotility results to aggregate and report.
Secondary
EGD Abnormalities
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.
Time frame: 12 months
Population: Study was terminated early. Biopsies were not obtained at 12 months and, as such, there were no corresponding results to analyze and report.
Secondary
EGD Abnormalities
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.
Time frame: Baseline
Population: Biopsies were not obtained at baseline and, as such, there were no corresponding results to analyze and report.
Secondary
EGD Abnormalities
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.
Time frame: 6 months
Population: Study was terminated early. Biopsies were not obtained at 6 months and, as such, there were no corresponding results to analyze and report.
Secondary
Esophageal pH Levels
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.
Time frame: 12 months
Population: Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report.
Secondary
Esophageal pH Levels
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.
Time frame: 6 months
Population: Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report.
Secondary
Esophageal pH Levels
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.
Time frame: Baseline
Population: Esophageal samples were not collected and therefore there was no esophageal pH results to report.
Secondary
Gastric Emptying Study
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
Time frame: Baseline (up to 4 hours)
Population: Study was terminated early and the gastric emptying study was not collected. As such, there were no related gastric emptying data to aggregate and report.
Secondary
Use of Anti-reflux Medication
The number of patients using anti-reflux medications will be tabulated.
Time frame: Baseline
Population: Study was terminated early and data related to the use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report.