An interventional study of Balloon inflation in Throat Pain After EUS Insertion, sponsored by Seoul National University Hospital. Status unknown. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
EUS will be inserted with conventional method.
EUS will be inserted with balloon inflated method
Procedure: Balloon inflation
EUS balloon inflation will be done before insertion through the subjects throat
Throat pain
Throat pain assessed by NRS scale 5 or over will be considered as positive
Time frame: Assess right after the end of the EUS procedure
Throat pain intensity
Throat pain assessed in NRS scale which has a range of 0 to 10
Time frame: Assess right after the end of the EUS procedure
EUS Insertion failure rate
To assess the EUS insertion failure rate
Time frame: Right after insertion
Damaged balloon rate
Inability to inflate the balloon after insertion of EUS will be counted
Time frame: during EUS procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital