NCT06230536

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
31mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Feb 2024Dec 2028

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

4.1 years

First QC Date

January 19, 2024

Last Update Submit

July 25, 2024

Conditions

Esophageal Achalasia

Keywords

timed baryum esophagogramhigh-resolution manometry with impedancemetryesophageal clearanceEckardt score

Outcome Measures

Primary Outcomes (1)

  • esophageal clearance

    Difference of esophageal clearance determined by HRiM and TBE in patients with achalasia treated by POEM at 3 months

    3 months

Secondary Outcomes (7)

  • Efficacy : score of Eckardt

    3 months, 12 months

  • Efficacy : esophageal clearance

    3 months

  • Quality of life : Score QLQ-SF36

    3 months

  • Quality of life : QLQ-OES24

    3 months

  • Quality of life : GERD-HRQL

    3 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a single cohort of all patients with achalasia and treated by POEM at Bordeaux University Hospital and having performed HRiM and TBE in routine care

You may qualify if:

  • The patients included are all patients treated by POEM at Bordeaux University Hospital between October 2020 and September 2024.

You may not qualify if:

  • Primary POEM failure, lost to follow-up, absence of completion of the ES, TBE or HRiM pre or post poem at 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Bordeaux

Pessac, France

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Arthur BERGER, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur BERGER, MD

CONTACT

+33557656439arthur.berger@chu-bordeaux.fr

Florian GROUSEZ

CONTACT

florian.grousez@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)