Esophageal High Resolution Manometry and Dysphagia

Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284894

Enrollment

247

Registered

2011-01-27

Start date

2011-02-28

Completion date

2013-12-31

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Dysphagia, Conventional manometry, High resolution manometry

Brief summary

Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

Interventions

DEVICEConventional manometry

Conventional esophageal manometry

DEVICEHigh resolution manometry

High resolution esophageal manometry

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female older than 18 years * Patient with unexplained dysphagia * Patient without cause of dysphagia on eso-gastro-duodenal endoscopy * Patient referred for esophageal manometry * Patient with health insurance * Informed consent signed

Exclusion criteria

* Patient younger than 18 years * Allergy to one component of manometry catheter * Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry * Patient unable to give his consent or legally incompetent * Patient non qualified according to the investigator * Patient refusal or absence of informed consent signed * Concomitant participation to another study

Design outcomes

Primary

Measure	Time frame
Percentage of patients correctly diagnosed for esophageal motility disorder	6 months

Secondary

Measure	Time frame
Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)	24 hours
Duration of examination and study analysis	day 0
Cost of patient care within the 6 months following the manometry	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026