A Comparison of Endoscopic Ultrasound Insertion Methods: Conventional vs Inflated Balloon Method

Seoul National University Hospital0 sites482 target enrollmentSeptember 2016

ConditionsThroat Pain After EUS Insertion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Throat Pain After EUS Insertion
Sponsor: Seoul National University Hospital
Enrollment: 482
Primary Endpoint: Throat pain
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Endoscopic ultrasonography (EUS) is an essential technique required in diagnosis of pancreatobiliary diseases. In previous studies, 6% of patients who undergone EUS had significant throat pain. (NRS scale 5 or greater) Although some endoscopists think balloon inflation while EUS insertion could result in decreased throat damage and pain, there is no data to back up. We designed a single center randomized pilot study to compare throat pain caused by EUS insertion with conventional vs balloon inflation method.

Detailed Description

All patients who are undergoing EUS with radial type echoendoscope will be asked for an informed consent. Subjects will be randomized to conventional insertion arm and balloon inflated insertion arm. All patients will be sedated according to SNUH endoscopy center protocol. Conventional insertion will be done in conventional insertion group, and balloon inflation before the start of procedure will be done in balloon inflated insertion arm. After the EUS procedure is finished, subject will be moved to a recovery room. As soon as the subject is recovered from sedation, throat pain will be assessed in NRS scale and be recoreded. Information of insertion failure and balloon damage during insertion will be also collected.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

September 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel