Endoscopical Dilation of Benign Esophageal Strictures

Although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. The aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Stenosis Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Symptomatic dysphagia with an endoscopic picture suggestive of a benign disease

Exclusion criteria

Suspicion of achalasia or malignancy. If the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion

Treatment and study plan

Dilation 10 sec

Device

Other names: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

Dilation 2 min

Device

Other names: CRE, Controlled Radial Expansion, Boston Scientific Cork Ltd

Primary outcomes

Relief from dysphagia

Time frame: 1 year from dilation

Sponsors and collaborators

Lead sponsor

University Hospital, Umeå

Other

Collaborators

Boston Scientific Corporation
Uppsala University

Registry information

Official study title

Endoscopical Dilation of Benign Esophageal Strictures - a Randomized, Clinical Trial, Comparing Two Different Inflation Times.

Important dates

Study start: 2003
Primary completion: 2006
First posted: Nov 30, 2012
Registry last updated: Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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