COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Achalasia: Mechanisms Underlying Treatment Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Show Show detailed description

Layout table for study information
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

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

  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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT02055469

Layout table for location contacts
Contact: Rhys Hewett, MBBS 02087253569

Layout table for location information
United Kingdom
Barts Health NHS Trust
London, UK, United Kingdom, E1 1BB
Contact: Rhys Hewett, MBBS    02035940093 ext 0093   
Contact: Etsuro Yazaki, PhD    02035940093 ext 0093   
Principal Investigator: Daniel Sifrim, MD, PhD         
Sub-Investigator: Jafar Jafari, MBBS         
Sub-Investigator: Etsuro Yazaki, PhD         
Sponsors and Collaborators
Barts & The London NHS Trust
Layout table for additonal information
Responsible Party: Barts & The London NHS Trust Identifier: NCT02055469    
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:
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases