A Comparison of Endoscopic Ultrasound Insertion Methods

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

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.

Study Overview

• Status: Unknown
• Conditions: Throat Pain After EUS Insertion
• Intervention / Treatment: Procedure: Balloon inflation

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 Type: Interventional
• Enrollment (Anticipated): 482
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Sang Hyub Lee, MD. PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Endoscopic ultrasonography
• Other Study ID Numbers: 2016-0315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO