NCT01284894

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

January 26, 2011

Last Update Submit

December 13, 2025

Conditions

Dysphagia

Keywords

DysphagiaConventional manometryHigh resolution manometry

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients correctly diagnosed for esophageal motility disorder

    6 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Conventional manometry

OTHER
Device: Conventional manometry

High resolution manometry

EXPERIMENTAL
Device: High resolution manometry

Interventions

Conventional manometryDEVICE

Conventional esophageal manometry

Conventional manometry
High resolution manometryDEVICE

High resolution esophageal manometry

High resolution manometry

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03

Lyon, Lyon, 69437, France

Location

Related Publications (1)

  • Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.

    PMID: 26832656RESULT

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sabine ROMAN, Dr

    Unité d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - 69437 Lyon Cedex 03- France

    PRINCIPAL INVESTIGATOR

  • Stanislas BRULEY DES VARANNES

    Service d'Hépato-Gastro-Entérologie - CHU Hôtel Dieu - Place A Ricordeau - 44093 Nantes Cedex - France

    PRINCIPAL INVESTIGATOR

  • Franck ZERBIB

    Service d'Hépato-Gastro-Entérologie - Hôpital Saint-André - 33075 Bordeaux Cedex - France

    PRINCIPAL INVESTIGATOR

  • Guillaume GOURCEROL

    Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen - 76031 Rouen Cedex - France

    PRINCIPAL INVESTIGATOR

  • Silvana PERRETTA

    Pole Hépato- Digestif, Service de Chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - 1 place de l'Hôpital - 67091 Strasbourg cedex - France

    PRINCIPAL INVESTIGATOR

  • Franck ROPERT

    Service d'Hépato-Gastro-Entérologie - CHU Pontchaillou - Rue H. le Guillou - 35033 Rennes cedex - France

    PRINCIPAL INVESTIGATOR

  • François MION, MD

    Service d'Hépato-Gastro-Entérologie, Hôpital de la Croix-Rousse , 69317 Lyon

    PRINCIPAL INVESTIGATOR

  • Benoit COFFIN, MD

    Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, 92700 Colombes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)