NCT00604942

Brief Summary

Recent work at St. Thomas' has validated an innovative new design of a multichannel intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in healthy volunteers and patients. This project will establish the clinical value of volume sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same catheter (ROC analysis). Studies will assess:

  1. 1.The accuracy of volume measurements and correlation between symptoms and the volume of bolus retention in patients with dysphagia.
  2. 2.The accuracy of volume measurements and correlation between symptoms and reflux volume in patients with reflux disease.
  3. 3.the oesophageal dysfunction that results in bolus escape
  4. 4.the abnormal events at the gastro-oesophageal junction (reflux barrier) that allow reflux to occur.

Trial Health

57
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

2.9 years

First QC Date

January 15, 2008

Last Update Submit

July 31, 2009

Conditions

AchalasiaGORD

Keywords

OesophagusDysphagiaImpedanceHigh Resolution ManometryPeristalsisContractile PressureCoordination of contractionBolus transport

Outcome Measures

Primary Outcomes (3)

  • Does vMII provide an accurate assessment of volume in disease?

    3 years

  • Does vMII assessment of volume improve the accuracy with which 'events' are associated with symp?

    3 years

  • Does symp improvement post treatment correlate with reduced 'volume events'?.

    3 years

Study Arms (4)

Achalasia

EXPERIMENTAL

Long vs Short Myotomy repair of Achalasia

Procedure: Heller's Myotomy

Dysphagia control

EXPERIMENTAL

Conservative Management

Drug: domperidone or esomeprazole (Conservative management)

GORD for surgery

EXPERIMENTAL

Partial vs Full Fundoplication repair

Procedure: Nissen Fundoplication

GORD not for surgery

EXPERIMENTAL

esomeprazole 40 mg vs no esomeprazole

Drug: Esomeprazole 40 mg

Interventions

Heller's MyotomyPROCEDURE

Long vs Short Heller's Myotomy for Achalasia

Achalasia
Nissen FundoplicationPROCEDURE

Partial vs Full Fundoplication for GORD

GORD for surgery
domperidone or esomeprazole (Conservative management)DRUG

Conservative management for dysphagia not referred for surgery. Conservative management: balloon dilatation or drugs such as domperidone 10 mg or esomeprazole 40 mg

Dysphagia control
Esomeprazole 40 mgDRUG

Esomeprazole vs no esomeprazole for GORD not referred for surgery

GORD not for surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female
  • at least 18 years of age
  • have given informed consent for the vMII and Barium videofluoroscopy
  • have symptoms of reflux, dysphagia, have known achalasia or are planned for anti-reflux surgery

You may not qualify if:

  • with medications influencing gastrointestinal function within 3 days of the study
  • with those on anticoagulants
  • with any hematological abnormalities
  • with any evidence of infectious disease
  • who are pregnant or breast-feeding or sexually active and not on contraception.
  • with evidence or history of drug or alcohol abuse within the past two years
  • with diabetes mellitus
  • with severe physical or mental health concerns on screening which may contribute to the ability to comply with study requirements
  • with active co-morbid conditions
  • with oesophageal surgery or stent (dilation acceptable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oesophageal Laboratory, GSTT

London, London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Esophageal AchalasiaDeglutition Disorders

Interventions

Heller MyotomyFundoplicationDomperidoneEsomeprazoleConservative Treatment

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeSphincterotomyMyotomyPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesTherapeutics

Study Officials

  • Mark Fox, MD

    Honorary Consultant and Senior Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 30, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

GB(1)