Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230536
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-19
Brief Title:
MARIMPACH Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
Status:
RECRUITING
Status Verified Date:
2024-07
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:
MARIMPACH
Brief Summary:
Outcome after treatment of achalasia is usually assessed by the Eckardt score ES The timed barium esophagogram TBE is used to objectively assess esophageal clearance after treatment High-resolution manometry with impedancemetry HRiM provides information on esophageal clearance of liquids in addition to motility parameters The aim of this study was to compare esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM
Detailed Description:
Consecutive patients treated with POEM had pre and post-POEM assessment with ES TBE and HRiM Treatment failure was defined by an ES 3 at 3 months post-POEM Incomplete esophageal clearance IEC was defined by the presence of an esophageal stasis 2 cm at 5 minutes in HRiM andor TBE The Eckardt score is evaluated at one year to estimate the prognostic value of measurements of esophageal clearance after treatment on long-term symptoms The evaluation of the Eckardt score will be compared to the quality of life score All of these examinations are carried out as part of routine care
The supposed superiority of HRiM in the evaluation of esophageal clearance systematically carried out in the assessment of Achalasia could lead to no longer using TBE which is a irradiating examination for the patient
The supposed superiority of HRiM in the evaluation of esophageal clearance systematically carried out in the assessment of Achalasia could lead to no longer using TBE which is a irradiating examination for the patient
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