Clinical Trial: Achalasia: Mechanisms Underlying Treatment Failure

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Achalasia; Mechanisms Underlying Persistent Symptoms After Treatment

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.


Detailed Summary:

This is observational study of patients with achalasia (with or without treatment). Treatment will have been a previous Heller's myotomy or pneumatic dilatation (and is not randomised). Patients with known or suspected achalasia will attend the GI physiology unit at the Royal London Hospital for standard care. Standard care involves assessing the perception of dysphagia with questionnaires, assessing oesophageal circular muscle function with high resolution oesophageal manometry (HRM) and oesophageal emptying with a timed barium oesophagram (TBO). The two experimental tests performed as part of the study (which are not currently routine care) are EndoFLIP and HFIUS.

On arrival at the GI physiology unit, patients will be given verbal and written information about the study (including standard care and non-standard tests). They will then be asked if they wish to participate. Informed written consent will be obtained.

Participants will complete questionnaires and HRM. If HRM is not consistent with achalasia, the patient's participation in the study ends. If HRM is consistent with achalasia then the participant will then undergo EndoFLIP, HFIUS and TBO.

Assessments are as follows (but are not necessarily done in the order given:

A. Perception of dysphagia (using MAYO and Eckardt questionnaires)

Dysphagia questionnaires are a non-intrusive, quick and well validated method of assessing the perception of dysphagia and are considered part of standard care.

B. Oesophageal circular muscle function (using HRM)

HRM is part of standard care and is performed in the GI physiology unit routine
Sponsor: Barts & The London NHS Trust

Current Primary Outcome:

  • Perception of dysphagia [ Time Frame: Baseline (At recruitment ) ]
    Questionnaires
  • Oesophageal circumferential muscle contractility [ Time Frame: Baseline (At recruitment ) ]
    Using high resolution oesophageal manometry
  • Oesophageal longitudinal muscle contraction [ Time Frame: Baseline (At recruitment ) ]
    High frequency intraluminal oesophageal ultrasound
  • Oesophageal emptying [ Time Frame: Baseline (At recruitment ) ]
    Timed barium oesophagram
  • Assessment of oesophageal and LOS distensibility [ Time Frame: Baseline (At recruitment ) ]
    Using endoscopic functional luminal imaging probe (EndoFLIP)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Barts & The London NHS Trust

Dates:
Date Received: February 4, 2014
Date Started: March 2014
Date Completion: March 2015
Last Updated: February 4, 2014
Last Verified: February 2014