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Achalasia: Mechanisms Underlying Treatment Failure

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ClinicalTrials.gov Identifier: NCT02055469
Recruitment Status : Unknown
Verified February 2014 by Barts & The London NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:

In patients with achalasia, the relationship between the perception of dysphagia, oesophageal emptying, lower oesophageal sphincter (LOS) distensibility and oesophageal circular and longitudinal muscle contraction is not clear.

We aim to characterize oesophageal circumferential and longitudinal muscle contractility and LOS distensibility in patients with achalasia (either before or after treatment). This may allow an understanding of the mechanisms underlying persistent dysphagia and delayed oesophageal emptying after treatment.


Condition or disease
Achalasia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Achalasia; Mechanisms Underlying Persistent Symptoms After Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Perception of dysphagia [ Time Frame: Baseline (At recruitment ) ]
    Questionnaires

  2. Oesophageal circumferential muscle contractility [ Time Frame: Baseline (At recruitment ) ]
    Using high resolution oesophageal manometry

  3. Oesophageal longitudinal muscle contraction [ Time Frame: Baseline (At recruitment ) ]
    High frequency intraluminal oesophageal ultrasound

  4. Oesophageal emptying [ Time Frame: Baseline (At recruitment ) ]
    Timed barium oesophagram

  5. Assessment of oesophageal and LOS distensibility [ Time Frame: Baseline (At recruitment ) ]
    Using endoscopic functional luminal imaging probe (EndoFLIP)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with achalasia (or suspected achalasia) either before or after treatment referred from secondary care to the GI physiology unit of the Royal London Hospital
Criteria

Inclusion Criteria:

  • Patients with achalasia diagnosed on HRM criteria, with or without previous treatment
  • Written ICF signed voluntarily before the first trial-related activity.
  • Male or female, aged 18-70
  • If the subject is a woman of childbearing potential, she must have a negative urine pregnancy test before the start of assessments

Exclusion Criteria:

  • Any abnormal oesophageal motility finding that is not consistent with achalasia
  • History of gastrointestinal tract surgery, fundoplication, endoscopic anti reflux procedure or any other recent abdominal operation in the last 6 months
  • Major psychiatric, neurological, respiratory, liver, haemorrhagic and cardiac disorders, malignancies
  • Pregnancy
  • Subjects with a documented history of long segment (>3 cm) Barrett's oesophagus, large (> 3 cm) hiatus hernia, structural abnormalities of oesophagus (i.e. Rings, webs, scleroderma)
  • Use of prokinetic medication less than 7 days before the start of the study
  • Any condition that in the opinion of the Investigator would complicate or compromise the trial or the well-being of the subject.
  • Evidence of any clinically relevant pathology that could interfere with trial results or put subject safety at risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055469


Contacts
Contact: Rhys Hewett, MBBS 02087253569 rhyshewett@doctors.net.uk

Locations
United Kingdom
Barts Health NHS Trust Not yet recruiting
London, UK, United Kingdom, E1 1BB
Contact: Rhys Hewett, MBBS    02035940093 ext 0093    rhyshewett@doctors.net.uk   
Contact: Etsuro Yazaki, PhD    02035940093 ext 0093    e.yazaki@qmul.ac.uk   
Principal Investigator: Daniel Sifrim, MD, PhD         
Sub-Investigator: Jafar Jafari, MBBS         
Sub-Investigator: Etsuro Yazaki, PhD         
Sponsors and Collaborators
Barts & The London NHS Trust

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT02055469     History of Changes
Other Study ID Numbers: 009393
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014

Keywords provided by Barts & The London NHS Trust:
Achalasia

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases