MedDataX Logo

Esophageal High Resolution Manometry and Dysphagia

NCT ID: NCT01284894

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysphagia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dysphagia Conventional manometry High resolution manometry

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional manometry

Group Type OTHER

Conventional manometry

Intervention Type DEVICE

Conventional esophageal manometry

High resolution manometry

Group Type EXPERIMENTAL

High resolution manometry

Intervention Type DEVICE

High resolution esophageal manometry

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional manometry

Conventional esophageal manometry

Intervention Type DEVICE

High resolution manometry

High resolution esophageal manometry

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sabine ROMAN, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Stanislas BRULEY DES VARANNES

Role: PRINCIPAL_INVESTIGATOR

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

Franck ZERBIB

Role: PRINCIPAL_INVESTIGATOR

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

Guillaume GOURCEROL

Role: PRINCIPAL_INVESTIGATOR

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

Silvana PERRETTA

Role: PRINCIPAL_INVESTIGATOR

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

Franck ROPERT

Role: PRINCIPAL_INVESTIGATOR

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

François MION, MD

Role: PRINCIPAL_INVESTIGATOR

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

Benoit COFFIN, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Lyon, Lyon, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 26832656 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010.624/28

Identifier Type: -

Identifier Source: org_study_id