Global Assessment of Endoscopic Ultrasound Performance Skills

E01.370.350.850.280 Clinical Trial

Official title:

Global Assessment of Endoscopic Ultrasound Performance Skills - a New Tool to Measure the Learning Curve and Technical Skills of Endosonografists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455570
• Other study ID #: Dnr 721-13
• Status: Completed
• Start date: August 2014
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Physicians in EUS-traning without adequate supervision

• Experimental or therapeutic EUS outside the clinical setting

Related Conditions & MeSH terms

• E01.370.350.850.280
• F02.784.629.529.274
• I02.399
• J01.897.608
• N06.850.135.060.075.399

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Wani S, Coté 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Imediate
Secondary	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.	2 months
Secondary	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.	<48 hours