Clinical trial NCT01284894: Esophageal High Resolution Manometry and Dysphagia
Official title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: Dysphagia
Conventional manometry
High resolution manometry
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients correctly diagnosed for esophageal motility disorder
timeFrame: 6 months
Secondary outcomes:
measure: Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)
timeFrame: 24 hours
measure: Duration of examination and study analysis
timeFrame: day 0
measure: Cost of patient care within the 6 months following the manometry
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03
Study officials:
affiliation: Unité d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - 69437 Lyon Cedex 03- France
name: Sabine ROMAN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Hépato-Gastro-Entérologie - CHU Hôtel Dieu - Place A Ricordeau - 44093 Nantes Cedex - France
name: Stanislas BRULEY DES VARANNES
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Hépato-Gastro-Entérologie - Hôpital Saint-André - 33075 Bordeaux Cedex - France
name: Franck ZERBIB
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen - 76031 Rouen Cedex - France
name: Guillaume GOURCEROL
role: PRINCIPAL_INVESTIGATOR
affiliation: Pole Hépato- Digestif, Service de Chirurgie digestive et endocrinienne - Nouvel Hôpital Civil - 1 place de l'Hôpital - 67091 Strasbourg cedex - France
name: Silvana PERRETTA
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Hépato-Gastro-Entérologie - CHU Pontchaillou - Rue H. le Guillou - 35033 Rennes cedex - France
name: Franck ROPERT
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Hépato-Gastro-Entérologie, Hôpital de la Croix-Rousse , 69317 Lyon
name: François MION, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service d'Hépato-Gastroentérologie, Hôpital Louis Mourier, 92700 Colombes
name: Benoit COFFIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.