E01.370.350.850.280NCT02455570
Global Assessment of Endoscopic Ultrasound Performance Skills
An observational study of E01.370.350.850.280 and I02.399, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various suspicious malignancies. The learning curve of EUS is regarded long but so far the literature of this topic is minimal. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- E01.370.350.850.280, I02.399, J01.897.608
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to Dec 2020
- Phase
- Observational
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Endosonographists in traning under experienced supervision at tertiary endoscopy centers.
Who may be able to join
- EUS-examination with or without sampling performed for clinical reasons at one of the participating centers
- The EUS-examination is to be performed by a physician in training as endosonographist OR a physician with a completed training as endosonographist
- The EUS-examination is to be supervised by an experienced endosonographist
- Oral and written consent of the patients examined (age>18 years)
Who cannot join
- Physicians in EUS-traning without adequate supervision
- Experimental or therapeutic EUS outside the clinical setting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Assessment of Endoscopic Ultrasound Performance Skills - a New Tool to Measure the Learning Curve and Technical Skills of Endosonografists
Endoscopic ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various suspicious malignancies. The learning curve of EUS is regarded long but so far the literature of this topic is minimal. Few studies have been published and there are no standardized or validated methods to perform a systematic assessment of endosonographists in training. This study is an observational study dealing with the matter of assessing endosonographists in training.
Read the detailed description
Sahlgrenska Univeristy Hospital is tertiary university endoscopy center. At our endoscopy unit physicians/endoscopists train EUS under the supervision of an experienced endosonographist. Endosonographists examining patients referred for a routine, clinical EUS at the Sahlgrenska Univeristy hospital are candidates for being study subjects. Patients will not be examined by the study endosonographists if supervision is lacking.
External, collaborating centers will be invited to participte in the study given that the study inclusion criteria and ethical standard will be ensured.
The investigators of this study have developped a score sheet for the assessment of endosonographists in training to be used in a standard clinical setting. The score sheet is to be used by both the endosonographist in training (performer) for self-assessment and by the supervisor (observer) for assessment of the performer.
First, background data of the performer is recorded (pervious endoscopy experience etc). Then the performer starts the examination under the guidance of the observer. The observer performs continuous evaluation and assessment of the performer according to the skill parameters (N=5) of the Observer score sheet. Each parameter is ranked on a 1-5 scale (1=non-satisfactory performance, 5= excellent performance). Finally the observer is taking over, reevaluates the findings of the performer and finishes the examination.
After the examination the performer fullfills the Performer score sheet. Finally, both the performer and the observer record their preliminary diagosis of the lesion examined.
Adverse events and complications are recorded.
A follow-up of the medical records of the patient is performed 8 weeks after the EUS-examiantion with respect to the final diagnosis of the lesion of interest. The reference standard is set to best available combination of surgery, pathology and imaging reports. The performer´s assessment of the diagnosis is the categorized as CORRECT or FALSE. A correct diagnosis equals 3 Points and a false diagnosis equals 0 Points.
Results in terms of the total and mean score of all perfomers is calculated and collected in a study database. Feasibility of the study assessment sheet is evaluated. Statistical analysis of categorical data is finally applied for evaluating the results with respect to the progress and learning curve of the study participants.
- Being tested
- No intervention
- Keywords
- Endoscopic Ultrasound, Quality Management, Education and training, Safety, Learning curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
EUS performance
The assessment and scoring of the endosonographist in training (Performer) is performed during the EUS-examiantion itself by the supervisor (Observer) in real-time. The total score is a compound of five parameters assessed each on a 1-5 scale (1=non-satisfactory performance, 5=excellent performance). A study unique assessment sheet is developped.
Measured: Imediate
Secondary outcomes (2)
EUS diagnosis
The performer states his/her preliminary diagnosis of the lesion examined by EUS based on his/her findings. The correct diagnosis of the examined lesion is reviewed and recorded from surgery/pathology/imaging reports of the medical files in each individual case at a time frame of 8 weeks after EUS. The preliminary diagnosis stated by the performer is then categorized as CORRECT or FALSE.
Measured: 2 months
Safety and complications
Adverse events and complications occuring during the procedure or within 48 hours with a potential causal relation to the EUS-examination is recorded.
Measured: <48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for E01.370.350.850.280Studies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Riadh Sadik, Ass prof, Principal investigator, Sahlgrenska University Hospital, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455570
- Sponsor's protocol ID
- Dnr 721-13
- Status last verified
- Dec 2020
- First submitted
- 22 May 2015
- Last updated
- 22 Dec 2020
- Results posted
- No
Publications
Wani S, Cote GA, Keswani R, Mullady D, Azar R, Murad F, Edmundowicz S, Komanduri S, McHenry L, Al-Haddad MA, Hall M, Hovis CE, Hollander TG, Early D. Learning curves for EUS by using cumulative sum analysis: implications for American Society for Gastrointestinal Endoscopy recommendations for training. Gastrointest Endosc. 2013 Apr;77(4):558-65. doi: 10.1016/j.gie.2012.10.012. Epub 2012 Dec 20.
PubMed 23260317Hedenstrom P, Marasco G, Eusebi LH, Lindkvist B, Sadik R. GAPS-EUS: a new and reliable tool for the assessment of basic skills and performance in EUS among endosonography trainees. BMJ Open Gastroenterol. 2021 Jun;8(1):e000660. doi: 10.1136/bmjgast-2021-000660.
PubMed 34108134
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Assessment of Endoscopic Ultrasound Performance Skills - a New Tool to Measure the Learning Curve and Technical Skills of Endosonografists
- ClinicalTrials.gov ID
- NCT02455570
- Acronym / sponsor ID
- Dnr 721-13
- Keywords
- Endoscopic Ultrasound, Quality Management, Education and training, Safety, Learning curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 28 May 2015 (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 ultrasound (EUS) is a mini-invasive diagnostic procedure in the work-up of various suspicious malignancies. The learning curve of EUS is regarded long but so far the literature of this topic is minimal. Few studies have been published and there are no standardized or validated methods to perform a systematic assessment of endosonographists in training. This study is an observational study dealing with the matter of assessing endosonographists in training.
Detailed description
Sahlgrenska Univeristy Hospital is tertiary university endoscopy center. At our endoscopy unit physicians/endoscopists train EUS under the supervision of an experienced endosonographist. Endosonographists examining patients referred for a routine, clinical EUS at the Sahlgrenska Univeristy hospital are candidates for being study subjects. Patients will not be examined by the study endosonographists if supervision is lacking.
External, collaborating centers will be invited to participte in the study given that the study inclusion criteria and ethical standard will be ensured.
The investigators of this study have developped a score sheet for the assessment of endosonographists in training to be used in a standard clinical setting. The score sheet is to be used by both the endosonographist in training (performer) for self-assessment and by the supervisor (observer) for assessment of the performer.
First, background data of the performer is recorded (pervious endoscopy experience etc). Then the performer starts the examination under the guidance of the observer. The observer performs continuous evaluation and assessment of the performer according to the skill parameters (N=5) of the Observer score sheet. Each parameter is ranked on a 1-5 scale (1=non-satisfactory performance, 5= excellent performance). Finally the observer is taking over, reevaluates the findings of the performer and finishes the examination.
After the examination the performer fullfills the Performer score sheet. Finally, both the performer and the observer record their preliminary diagosis of the lesion examined.
Adverse events and complications are recorded.
A follow-up of the medical records of the patient is performed 8 weeks after the EUS-examiantion with respect to the final diagnosis of the lesion of interest. The reference standard is set to best available combination of surgery, pathology and imaging reports. The performer´s assessment of the diagnosis is the categorized as CORRECT or FALSE. A correct diagnosis equals 3 Points and a false diagnosis equals 0 Points.
Results in terms of the total and mean score of all perfomers is calculated and collected in a study database. Feasibility of the study assessment sheet is evaluated. Statistical analysis of categorical data is finally applied for evaluating the results with respect to the progress and learning curve of the study participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Endosonographists in traning under experienced supervision at tertiary endoscopy centers.
Key inclusion criteria (4 listed)
- EUS-examination with or without sampling performed for clinical reasons at one of the participating centers
- The EUS-examination is to be performed by a physician in training as endosonographist OR a physician with a completed training as endosonographist
- The EUS-examination is to be supervised by an experienced endosonographist
- Oral and written consent of the patients examined (age>18 years)
Key exclusion criteria (2 listed)
- Physicians in EUS-traning without adequate supervision
- Experimental or therapeutic EUS outside the clinical setting
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
EUS performance
Time frame: Imediate
The assessment and scoring of the endosonographist in training (Performer) is performed during the EUS-examiantion itself by the supervisor (Observer) in real-time. The total score is a compound of five parameters assessed each on a 1-5 scale (1=non-satisfactory performance, 5=excellent performance). A study unique assessment sheet is developped.
2 secondary outcomes
EUS diagnosis
Time frame: 2 months
Safety and complications
Time frame: <48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 23260317Wani S, Cote GA, Keswani R, Mullady D, Azar R, Murad F, Edmundowicz S, Komanduri S, McHenry L, Al-Haddad MA, Hall M, Hovis CE, Hollander TG, Early D. Learning curves for EUS by using cumulative sum analysis: implications for American Society for Gastrointestinal Endoscopy recommendations for training. Gastrointest Endosc. 2013 Apr;77(4):558-65. doi: 10.1016/j.gie.2012.10.012. Epub 2012 Dec 20.
- Derived from this study: PubMed 34108134Hedenstrom P, Marasco G, Eusebi LH, Lindkvist B, Sadik R. GAPS-EUS: a new and reliable tool for the assessment of basic skills and performance in EUS among endosonography trainees. BMJ Open Gastroenterol. 2021 Jun;8(1):e000660. doi: 10.1136/bmjgast-2021-000660.
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.
Riadh Sadik, Ass prof principal investigator
Sahlgrenska University Hospital, Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E01.370.350.850.280 and I02.399, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 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: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUS performance (time frame: Imediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455570, which also lists 2 linked publications.
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 22 Dec 2020.