A Comparison of Endoscopic Ultrasound Insertion Methods

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Throat Pain After EUS Insertion

Intervention / Treatment
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* Procedure: Balloon inflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 20 to 80 Patients undergoing EUS with radial echoendoscope Exclusion Criteria: Refuse to participate the study Refuse EUS procedure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional insertion<br>EUS will be inserted with conventional method. | |
| Experimental: Balloon inflated insertion<br>EUS will be inserted with balloon inflated method | Procedure: Balloon inflation<br>* EUS balloon inflation will be done before insertion through the subjects throat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Throat pain | Throat pain assessed by NRS scale 5 or over will be considered as positive | Assess right after the end of the EUS procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Throat pain intensity | Throat pain assessed in NRS scale which has a range of 0 to 10 | Assess right after the end of the EUS procedure | 
| EUS Insertion failure rate | To assess the EUS insertion failure rate | Right after insertion | 
| Damaged balloon rate | Inability to inflate the balloon after insertion of EUS will be counted | during EUS procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic ultrasonography