A Comparison of Endoscopic Ultrasound Insertion Methods

Not Applicable

• Conditions: Throat Pain After EUS Insertion
• Interventions: Procedure: Balloon inflation

• Registration Number: NCT02924948
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-05
• Last Update Posted: 2016-10-05
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

• Patients aged from 20 to 80
• Patients undergoing EUS with radial echoendoscope

Exclusion Criteria

• Refuse to participate the study
• Refuse EUS procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon inflated insertion	Balloon inflation	EUS will be inserted with balloon inflated method

Primary Outcome Measures

Name	Time	Method
Throat pain	Assess right after the end of the EUS procedure	Throat pain assessed by NRS scale 5 or over will be considered as positive

Secondary Outcome Measures

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