Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01265550
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2010-12-21
Brief Title:
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 573 - A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Gastroesophageal reflux disease GERD which affects at least 20 of adult Americans may be especially common and severe in Veteran patients Proton pump inhibitors PPIs which block gastric acid production are the most effective medications for GERD and the VA spends more than 177 million each year on outpatient PPI prescriptions PPIs do not prevent the reflux of non-acidic material and do not completely eliminate esophageal acid exposure however and bothersome GERD symptoms persist in approximately 40 of patients treated with PPIs Recent studies using the new technique of esophageal pH impedance monitoring which detects the reflux of both acidic and non-acidic materials have shown that PPI-resistant GERD symptoms correlate with episodes of reflux acidic andor non-acidic in approximately one-half of patients For those patients an antireflux operation might relieve symptoms and obviate the expense of ineffective PPI therapy but the efficacy of modern laparoscopic fundoplication in this regard is not clear For patients with PPI-resistant GERD symptoms furthermore the efficacy of medications that that can prevent gastroesophageal reflux eg baclofen or diminish pain of esophageal origin eg neurotropic agents like desipramine also is not clear Study Hypothesis Laparoscopic antireflux surgery Nissen fundoplication is superior to medical therapy PPIs plus baclofen and desipramine for GERD patients who while on PPIs have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pHimpedance monitoring
Study Goals The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy PPIs plus baclofen and desipramine for GERD patients who while on PPIs have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pHimpedance monitoring and to compare the efficacy of each therapy with placebo Secondary goals are 1 To determine the frequency with which non-GERD disorders underlie PPI failure 2 To determine the frequency of functional gastrointestinal symptoms anxiety and depression in patients who have persistent heartburn while on PPIs 3 To determine whether functional gastrointestinal symptoms anxiety and depression is associated with the outcomes of medical and surgical therapies and 4 To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation
Study Design Up to 16 VA medical centers there will be a 30-month recruitment period to enroll 108 patients with heartburn that is refractory to PPI therapy Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life GERD-HRQL index and will have endoscopy esophageal manometry and esophageal pHimpedance monitoring while on PPI therapy Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pHimpedance monitoring will be randomized to one of three treatment groups Surgical Treatment laparoscopic Nissen fundoplication Active Medical Treatment omeprazole and baclofen initially desipramine for baclofen failures or Placebo Medical Treatment omeprazole placebo baclofen placebo desipramine All patients will have quarterly clinic visits for symptom scoring and laboratory testing At one year patients will have a final symptom scoring and repeat endoscopy esophageal manometry and esophageal pHimpedance monitoring Treatment success will be defined as 50 improvement in the GERD-HRQL score at 12 months Patients also will complete the Hospital Anxiety and Depression Scale HADS Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey SF-36 at baseline and one year The results will be correlated with treatment outcomes
Study Goals The primary goal is to compare the efficacy of laparoscopic Nissen fundoplication and medical therapy PPIs plus baclofen and desipramine for GERD patients who while on PPIs have persistent episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pHimpedance monitoring and to compare the efficacy of each therapy with placebo Secondary goals are 1 To determine the frequency with which non-GERD disorders underlie PPI failure 2 To determine the frequency of functional gastrointestinal symptoms anxiety and depression in patients who have persistent heartburn while on PPIs 3 To determine whether functional gastrointestinal symptoms anxiety and depression is associated with the outcomes of medical and surgical therapies and 4 To determine whether the outcome of Nissen fundoplication is associated with adherence to technical aspects of the operation
Study Design Up to 16 VA medical centers there will be a 30-month recruitment period to enroll 108 patients with heartburn that is refractory to PPI therapy Patients will have their baseline GERD symptoms scored using the GERD Health-Related Quality of Life GERD-HRQL index and will have endoscopy esophageal manometry and esophageal pHimpedance monitoring while on PPI therapy Patients who have episodes of heartburn that are associated with reflux episodes or with abnormal esophageal acid exposure by esophageal pHimpedance monitoring will be randomized to one of three treatment groups Surgical Treatment laparoscopic Nissen fundoplication Active Medical Treatment omeprazole and baclofen initially desipramine for baclofen failures or Placebo Medical Treatment omeprazole placebo baclofen placebo desipramine All patients will have quarterly clinic visits for symptom scoring and laboratory testing At one year patients will have a final symptom scoring and repeat endoscopy esophageal manometry and esophageal pHimpedance monitoring Treatment success will be defined as 50 improvement in the GERD-HRQL score at 12 months Patients also will complete the Hospital Anxiety and Depression Scale HADS Rome III Functional GI Disorders Questionnaire and the Short-Form Health Survey SF-36 at baseline and one year The results will be correlated with treatment outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None