Endoscopical Dilation of Benign Esophageal Strictures

University Hospital, Umeå

Status: Completed

Conditions: Dysphagia

Treatments: Device: Dilation 2 min; Device: Dilation 10 sec

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01738997

Dnr 02-499

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A

Experimental group

Description:

Dilation 10 sec

Treatment:

Device: Dilation 10 sec

Group B

Active Comparator group

Description:

Dilation 2 min

Treatment:

Device: Dilation 2 min