Throat Pain After EUS Insertion
Conditions
Keywords
Endoscopic ultrasonography
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.
Interventions
PROCEDUREBalloon inflation
EUS balloon inflation will be done before insertion through the subjects throat
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged from 20 to 80 * Patients undergoing EUS with radial echoendoscope
Exclusion criteria
* Refuse to participate the study * Refuse EUS procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactSang Hyub Lee, MD. PhD.
Outcome results
None listed