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Achalasia: Mechanisms Underlying Treatment Failure

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Barts & The London NHS Trust
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT02055469
First received: February 4, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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
Achalasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Achalasia; Mechanisms Underlying Persistent Symptoms After Treatment

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Perception of dysphagia [ Time Frame: Baseline (At recruitment ) ] [ Designated as safety issue: No ]
    Questionnaires

  • Oesophageal circumferential muscle contractility [ Time Frame: Baseline (At recruitment ) ] [ Designated as safety issue: No ]
    Using high resolution oesophageal manometry

  • Oesophageal longitudinal muscle contraction [ Time Frame: Baseline (At recruitment ) ] [ Designated as safety issue: No ]
    High frequency intraluminal oesophageal ultrasound

  • Oesophageal emptying [ Time Frame: Baseline (At recruitment ) ] [ Designated as safety issue: No ]
    Timed barium oesophagram

  • Assessment of oesophageal and LOS distensibility [ Time Frame: Baseline (At recruitment ) ] [ Designated as safety issue: No ]
    Using endoscopic functional luminal imaging probe (EndoFLIP)


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT02055469     History of Changes
Other Study ID Numbers: 009393
Study First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: United Kingdom: Barts Health NHS Trust

Keywords provided by Barts & The London NHS Trust:
Achalasia

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

ClinicalTrials.gov processed this record on November 25, 2014