A Comparison of Endoscopic Ultrasound Insertion Methods

Seoul National University

Status: Unknown

Conditions: Throat Pain After EUS Insertion

Treatments: Procedure: Balloon inflation

Study type: Interventional

Funder types: Other

Identifiers

NCT02924948

2016-0315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 482 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Refuse to participate the study
• Refuse EUS procedure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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482 participants in 2 patient groups

Conventional insertion

No Intervention group

Description:

EUS will be inserted with conventional method.

Balloon inflated insertion

Experimental group

Description:

EUS will be inserted with balloon inflated method

Treatment:

Procedure: Balloon inflation