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Completed

NCT Number: NCT02455570

Global Assessment of Endoscopic Ultrasound Performance Skills

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. EUS diagnosis

    Time frame: 2 months

    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. Safety and complications

    Time frame: <48 hours

    Adverse events and complications occuring during the procedure or within 48 hours with a potential causal relation to the EUS-examination is recorded.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 28, 2015
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.