Evaluating esophageal clearance in achalasia using advanced imaging techniques
Contribution of High-resolution Manometry With Impedancemetry for the Evaluation of Esophageal Clearance in Achalasia
University Hospital, Bordeaux · NCT06230536
This study is testing if a new way to measure how well the esophagus clears food can replace an older method that uses radiation for patients with achalasia who have had a specific surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06230536 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of high-resolution manometry with impedancemetry (HRiM) and timed barium esophagogram (TBE) in assessing esophageal clearance in patients with achalasia who have undergone peroral endoscopic myotomy (POEM). Patients will be evaluated before and after treatment using the Eckardt score, TBE, and HRiM to determine the prognostic value of these assessments on long-term symptoms. The study seeks to establish whether HRiM can replace TBE, which involves radiation exposure, in routine evaluations of esophageal clearance.
Who should consider this trial
Good fit: Ideal candidates are patients treated with POEM for achalasia at Bordeaux University Hospital between October 2020 and September 2024.
Not a fit: Patients who experience primary POEM failure or are lost to follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment methods for esophageal clearance in achalasia, enhancing patient outcomes and reducing radiation exposure.
How similar studies have performed: While the use of HRiM is gaining traction, this specific comparison with TBE in the context of achalasia treatment is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024. Exclusion Criteria: * Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.
Where this trial is running
Pessac
- Chu de Bordeaux — Pessac, France (RECRUITING)
Study contacts
- Principal investigator: Arthur BERGER, MD — University Hospital, Bordeaux
- Study coordinator: Arthur BERGER, MD
- Email: arthur.berger@chu-bordeaux.fr
- Phone: +33557656439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Achalasia, timed baryum esophagogram, high-resolution manometry with impedancemetry, esophageal clearance, Eckardt score