Global Assessment of Endoscopic Ultrasound Performance Skills

NCT02455570 | Completed

• 1 other identifier: Dnr 721-13
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Endoscopic Ultrasound; Quality Management; Education and training; Safety; Learning curve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• EUS diagnosis

  2 months

• Safety and complications

  <48 hours

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Endosonographists in traning under experienced supervision at tertiary endoscopy centers.

You may qualify if:

• 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)

You may not qualify if:

• Physicians in EUS-traning without adequate supervision
• Experimental or therapeutic EUS outside the clinical setting

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (2)

• 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.

  PMID: 23260317 BACKGROUND

• Hedenstrom 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.

  PMID: 34108134 DERIVED

Study Officials

• Riadh Sadik, Ass prof

  Sahlgrenska University Hospital, Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 28, 2015
• Study Start: August 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

SE (1)