Throat Pain After EUS InsertionNCT02924948
A Comparison of Endoscopic Ultrasound Insertion Methods
A study testing Balloon inflation in people with Throat Pain After EUS Insertion, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Throat Pain After EUS Insertion
- What is being tested?
- Balloon inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged from 20 to 80
- Patients undergoing EUS with radial echoendoscope
Who cannot join
- Refuse to participate the study
- Refuse EUS procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Balloon inflation
- Keywords
- Endoscopic ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon inflationProcedure or surgery
EUS balloon inflation will be done before insertion through the subjects throat
| Study group | Role | What they receive |
|---|---|---|
| Conventional insertion | No intervention | EUS will be inserted with conventional method. |
| Balloon inflated insertion | Experimental | EUS will be inserted with balloon inflated method Receives: Procedure: Balloon inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Throat pain
Throat pain assessed by NRS scale 5 or over will be considered as positive
Measured: Assess right after the end of the EUS procedure
Secondary outcomes (3)
Throat pain intensity
Throat pain assessed in NRS scale which has a range of 0 to 10
Measured: Assess right after the end of the EUS procedure
EUS Insertion failure rate
To assess the EUS insertion failure rate
Measured: Right after insertion
Damaged balloon rate
Inability to inflate the balloon after insertion of EUS will be counted
Measured: during EUS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throat Pain After EUS InsertionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang Hyub Lee, MD. PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924948
- Sponsor's protocol ID
- 2016-0315
- Status last verified
- Sep 2016
- First submitted
- 3 Oct 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Endoscopic Ultrasound Insertion Methods: Conventional vs Inflated Balloon Method
- ClinicalTrials.gov ID
- NCT02924948
- Acronym / sponsor ID
- 2016-0315
- Conditions
- Throat Pain After EUS Insertion
- Keywords
- Endoscopic ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional insertion | No intervention | –EUS will be inserted with conventional method. |
| Balloon inflated insertion | Experimental | Procedure: Balloon inflationEUS will be inserted with balloon inflated method |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged from 20 to 80
- Patients undergoing EUS with radial echoendoscope
Key exclusion criteria (2 listed)
- Refuse to participate the study
- Refuse EUS procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon inflationEUS balloon inflation will be done before insertion through the subjects throat | Procedure or surgery | Balloon inflated insertion |
Primary outcome
Throat pain
Time frame: Assess right after the end of the EUS procedure
Throat pain assessed by NRS scale 5 or over will be considered as positive
3 secondary outcomes
Throat pain intensity
Time frame: Assess right after the end of the EUS procedure
EUS Insertion failure rate
Time frame: Right after insertion
Damaged balloon rate
Time frame: during EUS procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Hyub Lee, MD. PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Balloon inflation in people with Throat Pain After EUS Insertion, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Hyub Lee, MD. PhD. (82-2-2072-2228, gidoctor@snuh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Throat pain (time frame: Assess right after the end of the EUS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.