Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03322553
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2017-10-17
Brief Title:
Endoscopic Full Thickness Plication GERD-X for the Treatment of PPI Dependent GERD
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Endoscopic Full Thickness Plication GERD-X for the Treatment of PPI Dependent GERD Randomized Double Blinded Sham Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Gastro-esophageal reflux disease GERD is a common gastrointestinal disorder with a significant proportion of patients becoming dependent on proton pump inhibitor PPI therapy Long term use of PPI therapy can be associated with side effects such as osteoporosis small intestinal bacterial overgrowth and renal failure Moreover some of the patients might be reluctant to take PPIs for long duration and prefer surgery over pharmacotherapy Endoscopic plication GERD-X is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD In endoscopic plication transmural sutures are applied at the gastro-esophageal GE junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent reflux Only few trials have evaluated the efficacy of endoscopic plication technique and reported encouraging results In this study we aim to evaluate the efficacy of a similar endoscopic technique but with application of two transmural sutures in randomized controlled method
Detailed Description:
Patients screening and inclusion
The study will be conducted over 6-month period Data of patients presenting with PPI dependent GERD will be recorded and maintained At initial screening GERD health related quality of life questionnaire GERD HRQL and requirement of anti-secretory medicines detailed drug history will be assessed along with gastroscopy All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines Basal lower esophageal sphincter LES pressure esophageal motility pattern 24-h esophageal acid exposure non acidic bolus reflux number of reflux episodes DeMeester score symptom index and symptom association probability would be assessed Those patients with pathologic esophageal acid exposure esophageal pH 4 for 42 of 24-h period will be included in the trial Patients will then be randomly assigned by a computer to either GERD-X or sham procedure with a target ratio of 11 The patient principle investigator and the study coordinators would be blinded to the treatment assignment
Intervention
In patients allocated to endoscopic plication endoscopic full-thickness plication will be performed using the GERDX system All procedures will be performed under general anesthesia Savary-guidewire will be placed into the stomach using a gastroscope The GERDX system will be introduced over the guidewire and into the stomach The subsequent procedure will be performed as described in previous studies using a similar device NDO Plicator According to study protocol at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the endoscope In sham procedure identical technique will be followed by positioning the plicator 1cm below the GE junction but sutures will not be deployed
Post intervention monitoring
Immediately after the intervention patients would be placed on soft diet and on demand analgesics for 5 days Twice daily PPI will be given for all patients and would be stopped after 7 days Thereafter if patient experiences reflux symptoms sucralfate H2 blocker and PPI would be started sequentially in case of no response to the former drug after a period of 7days of therapy on each drug Requirement and reintroduction of drugs will be enquired over phone and recorded appropriately
Follow up
Follow up visits will be carried out at 3 6 and 12 months During each visit gastroscopy will be done to assess the gastro-esophageal junction along with evaluation of GERD HRQL and requirement of PPI At 3 months post intervention esophageal manometry and 24-h pH impedance monitoring would be performed
Primary outcomes
Improvement in GERD HRQL by more than 50 from baseline at 3 months
Secondary outcomes
Improvement in GERD HRQL at 3 6 and 12 months Improvement in symptom score and requirement of PPI at 3 6 and 12 months Improvement in esophageal acid exposure and lower esophageal sphincter pressure at 3 months
Statistical Analysis The trial was designed to have a 90 power to detect a difference in GERD-HRQL post intervention at 5 level of significance
The rate of improvement in GERD-HRQL for sham group is 35 and for active group is 70 A sample size of 38 is required for each group to achieve a statistical power of 80 at 5 type I error
Statistical methods Continuous data will be expressed as median and inter-quartile range IQR Frequency will be expressed as percentage Continuous and categorical data between active and sham groups will be compared using Mann-Whitney U test and Chi-square test with Yates correction as applicable respectively P values below 005 will be considered significant
The study will be conducted over 6-month period Data of patients presenting with PPI dependent GERD will be recorded and maintained At initial screening GERD health related quality of life questionnaire GERD HRQL and requirement of anti-secretory medicines detailed drug history will be assessed along with gastroscopy All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines Basal lower esophageal sphincter LES pressure esophageal motility pattern 24-h esophageal acid exposure non acidic bolus reflux number of reflux episodes DeMeester score symptom index and symptom association probability would be assessed Those patients with pathologic esophageal acid exposure esophageal pH 4 for 42 of 24-h period will be included in the trial Patients will then be randomly assigned by a computer to either GERD-X or sham procedure with a target ratio of 11 The patient principle investigator and the study coordinators would be blinded to the treatment assignment
Intervention
In patients allocated to endoscopic plication endoscopic full-thickness plication will be performed using the GERDX system All procedures will be performed under general anesthesia Savary-guidewire will be placed into the stomach using a gastroscope The GERDX system will be introduced over the guidewire and into the stomach The subsequent procedure will be performed as described in previous studies using a similar device NDO Plicator According to study protocol at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of GE junction around the endoscope In sham procedure identical technique will be followed by positioning the plicator 1cm below the GE junction but sutures will not be deployed
Post intervention monitoring
Immediately after the intervention patients would be placed on soft diet and on demand analgesics for 5 days Twice daily PPI will be given for all patients and would be stopped after 7 days Thereafter if patient experiences reflux symptoms sucralfate H2 blocker and PPI would be started sequentially in case of no response to the former drug after a period of 7days of therapy on each drug Requirement and reintroduction of drugs will be enquired over phone and recorded appropriately
Follow up
Follow up visits will be carried out at 3 6 and 12 months During each visit gastroscopy will be done to assess the gastro-esophageal junction along with evaluation of GERD HRQL and requirement of PPI At 3 months post intervention esophageal manometry and 24-h pH impedance monitoring would be performed
Primary outcomes
Improvement in GERD HRQL by more than 50 from baseline at 3 months
Secondary outcomes
Improvement in GERD HRQL at 3 6 and 12 months Improvement in symptom score and requirement of PPI at 3 6 and 12 months Improvement in esophageal acid exposure and lower esophageal sphincter pressure at 3 months
Statistical Analysis The trial was designed to have a 90 power to detect a difference in GERD-HRQL post intervention at 5 level of significance
The rate of improvement in GERD-HRQL for sham group is 35 and for active group is 70 A sample size of 38 is required for each group to achieve a statistical power of 80 at 5 type I error
Statistical methods Continuous data will be expressed as median and inter-quartile range IQR Frequency will be expressed as percentage Continuous and categorical data between active and sham groups will be compared using Mann-Whitney U test and Chi-square test with Yates correction as applicable respectively P values below 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None