Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05422404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-06-16
First Post:
2022-05-19
Brief Title:
Anti-Reflux Mucosal AblationARMA and Anti-Reflux MucosectomyARMS in Gastroesophageal Reflux Disease
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
Comparison of Anti-Reflux Mucosal AblationARMA With Anti- Reflux MucosectomyARMS in Treatment of Gastroesophageal Reflux Disease- A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-06
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:
According to the current published data and treatment mechanism ARMS may led to more stenosis while ARMA may be less effective in long term follow-up The changes of patients life quality UGI tract microbiota before and after different endoscopic treatment are also limited So we want to conduct a exploratory prospective randomized controlled study in evaluating the mucosal healing demand of PPI life quality emotion status sleep quality esophageal motility acid exposure and saliva microbiota between chronic GERD patients receiving ARMS and ARMA treatment
Detailed Description:
In this study we will enroll 150 patients with chronic GERD Estimated 40 of patients will be excluded from the inclusion and exclusion criteria Of 90 patients eligible for the study estimating 20 may drop out before receiving ARMS or ARMA Estimated 72 patients will be randomized to receive ARMS or ARMA for GERD treatment After ARMA all patients will receive 4 weeks of PPI treatment Endoscopy and questionnaire follow-up will be performed on week 2 2 months 6 months and 12 months after treatment while HRM and 24 hours pH impedance study will be performed 6 months after treatment
The study will be carried out in 4 years In the 1st to 3rd year of study estimating 606030 patients will be evaluated and entered the study in the 1st 2nd and fisr half of 3rd year Then all the patients will be followed until the first half of 4th year At the second half of the 4th year the saliva sample will be processed data will be analyzed and the result will be written
1 st year study60 patients enrollment evluation and receiving endoscopy treatment with follow-up
2 nd year study60 patients enrollment evluation and receiving endoscopy treatment with follow-up
3 rd year study30 patients enrollment evluation and receiving endoscopy treatment with follow-up
4 th year study complete all patients follow-up sample processing data analysis and report writing
The study will be carried out in 4 years In the 1st to 3rd year of study estimating 606030 patients will be evaluated and entered the study in the 1st 2nd and fisr half of 3rd year Then all the patients will be followed until the first half of 4th year At the second half of the 4th year the saliva sample will be processed data will be analyzed and the result will be written
1 st year study60 patients enrollment evluation and receiving endoscopy treatment with follow-up
2 nd year study60 patients enrollment evluation and receiving endoscopy treatment with follow-up
3 rd year study30 patients enrollment evluation and receiving endoscopy treatment with follow-up
4 th year study complete all patients follow-up sample processing data analysis and report writing
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