A Comparison of Endoscopic Ultrasound Insertion Methods

NCT ID: NCT02924948

Last Updated: 2016-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 482 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

Throat Pain After EUS Insertion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional insertion

EUS will be inserted with conventional method.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Balloon inflated insertion

EUS will be inserted with balloon inflated method

Group Type: EXPERIMENTAL

Balloon inflation

Intervention Type: PROCEDURE

EUS balloon inflation will be done before insertion through the subjects throat

Interventions

Balloon inflation

EUS balloon inflation will be done before insertion through the subjects throat

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Refuse to participate the study
• Refuse EUS procedure

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sang Hyub Lee, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

Sang Hyub Lee, MD. PhD.

Role: CONTACT

gidoctor@snuh.org

82-2-2072-2228

Other Identifiers

2016-0315

Identifier Type: -

Identifier Source: org_study_id