Image Registered Gastroscopic Ultrasound (IRGUS) in human subjects: a pilot study to assess feasibility

 

 Buy Article Permissions and Reprints

Background and study aims: Endoscopic ultrasound (EUS) is a complex procedure due to the subtleties of ultrasound interpretation, the small field of observation, and the uncertainty of probe position and orientation. Animal studies demonstrated that Image Registered Gastroscopic Ultrasound (IRGUS) is feasible and may be superior to conventional EUS in efficiency and image interpretation. This study explores whether these attributes of IRGUS will be evident in human subjects, with the aim of assessing the feasibility, effectiveness, and efficiency of IRGUS in patients with suspected pancreatic lesions.

Patients and methods: This was a prospective feasibility study at a tertiary care academic medical center in human patients with pancreatic lesions on computed tomography (CT) scan. Patients who were scheduled to undergo conventional EUS were randomly chosen to undergo their procedure with IRGUS. Main outcome measures included feasibility, ease of use, system function, validated task load (TLX) assessment instrument, and IRGUS experience questionnaire.

Results: Five patients underwent IRGUS without complication. Localization of pancreatic lesions was accomplished efficiently and accurately (TLX temporal demand 3.7 %; TLX effort 8.6 %). Image synchronization and registration was accomplished in real time without procedure delay. The mean assessment score for endoscopist experience with IRGUS was positive (66.6 ± 29.4). Real-time display of CT images in the EUS plane and echoendoscope orientation were the most beneficial characteristics.

Conclusions: IRGUS appears feasible and safe in human subjects, and efficient and accurate at identification of probe position and image interpretation. IRGUS has the potential to broaden the adoption of EUS techniques and shorten EUS learning curves. Clinical studies comparing IRGUS with conventional EUS are ongoing.

References

• 1 Peters T, Cleary K eds. Image-guided interventions: technology and applications.. 1st edn. New York: Springer Science+Business Media; 2008: 1-560
  CrossrefGoogle Scholar
• 2 Vosburgh K G, Jolesz F A. The concept of image-guided therapy.  Acad Radiol. 2003;  10 176-179
  CrossrefPubMedGoogle Scholar
• 3 Brugge W R. Fine needle aspiration of pancreatic masses: the clinical impact.  Am J Gastroenterol. 2002;  97 2701-2702
  CrossrefPubMedGoogle Scholar
• 4 Kane R. Intraoperative ultrasonography: history, current state of the art, and future directions.  J Ultrasound Med. 2004;  23 1407-1420
  PubMedGoogle Scholar
• 5 Rösch T, Lorenz R, Braig C et al. Endoscopic ultrasound in pancreatic tumor diagnosis.  Gastrointest Endosc. 1991;  37 347-352
  CrossrefPubMedGoogle Scholar
• 6 Di Stasi M, Lencioni R, Solmi L. Ultrasound-guided fine needle biopsy of pancreatic masses: results of a multicenter study.  Am J Gastroenterol. 1998;  93 1329-1333
  CrossrefPubMedGoogle Scholar
• 7 Rattner D W, Fernandez-del Castillo C, Brugge W R et al. Defining the criteria for local resection of ampullary neoplasms.  Arch Surg. 1996;  131 366-371
  CrossrefPubMedGoogle Scholar
• 8 Ellsmere J, Stoll J, Wells 3rd W et al. A new visualization technique for laparoscopic ultrasonography.  Surgery. 2004;  136 84-92
  CrossrefPubMedGoogle Scholar
• 9 Ambardar S, Arnell T D, Whelan R L et al. A preliminary, prospective study of the usefulness of a magnetic endoscope locating device during colonoscopy.  Surg Endosc. 2005;  19 897-901
  CrossrefPubMedGoogle Scholar
• 10 Shah S G, Brooker J C, Thapar C et al. Effect of magnetic endoscope imaging on patient tolerance and sedation requirements during colonoscopy: a randomized controlled trial.  Gastrointest Endosc. 2002;  55 832-837
  CrossrefPubMedGoogle Scholar
• 11 Shah S G, Saunders B P, Brooker J C et al. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers.  Gastrointest Endosc. 2000;  52 1-8
  CrossrefPubMedGoogle Scholar
• 12 Schwarz Y, Mehta A C, Ernst A et al. Electromagnetic navigation during flexible bronchoscopy.  Respiration. 2003;  70 516-522
  CrossrefPubMedGoogle Scholar
• 13 Herth F J, Ernst A, Eberhardt R et al. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum.  Eur Respir J. 2006;  28 910-914
  CrossrefPubMedGoogle Scholar
• 14 Shen S H, Fennessy F, McDannold N et al. Image-guided thermal therapy of uterine fibroids.  Semin Ultrasound CT MR. 2009;  30 91-104
  CrossrefPubMedGoogle Scholar
• 15 Dimaio S P, Archip N, Hata N et al. Image-guided neurosurgery at Brigham and Women’s Hospital.  IEEE Eng Med Biol Mag. 2006;  25 67-73
  CrossrefPubMedGoogle Scholar
• 16 Vosburgh K G, Stylopoulos N, San Jose Estepar R et al. EUS with CT improves efficiency and structure identification over conventional EUS.  Gastrointest Endosc. 2007;  65 866-870
  CrossrefPubMedGoogle Scholar
• 17 Besl P, McKay N. A method for Registration of 3-D Shapes.  IEEE Transactions on Pattern Analysis and Machine Intelligence (PAMI). 1992;  14 239-256
  CrossrefPubMedGoogle Scholar
• 18 Cao A, Chintamani K K, Pandya A K, Ellis R D. NASA TLX: software for assessing subject mental workload.  Behavior Research Methods. 2009;  41 113-117
  CrossrefPubMedGoogle Scholar
• 19 Hart S G, Staveland L E. Development of NASA-TLX (Task Load Index): results of empirical and theoretical research.. In: Hancock P A, Meshkati N, eds. Human mental workload.. Amsterdam: Elsevier; 1988: 139-183
  Google Scholar
• 20 Saleem J J, Patterson E S, Militello L et al. Impact of clinical reminder redesign on learnability, efficiency, usability, and workload for ambulatory clinic nurses.  J Am Med Inform Assoc. 2007;  14 632-640
  CrossrefPubMedGoogle Scholar
• 21 Temple J G, Warm J S, Dember W N et al. The effects of signal salience and caffeine on performance, workload, and stress in an abbreviated vigilance task.  Hum Factors. 2000;  42 183-194
  CrossrefPubMedGoogle Scholar
• 22 Hakan A, Nilsson L. The effects of a mobile telephone task on driver behavior in a car following situation.  Acc Anal Prev. 1995;  27 707-715
  CrossrefPubMedGoogle Scholar
• 23 Averty P, Collet C, Dittmar A et al. Mental workload in air traffic control: an index constructed from field tests.  Aviat Space Environ Med. 2004;  75 333-341
  PubMedGoogle Scholar
• 24 Park J, Jung W. A study on the validity of task complexity measure of emergency operating procedures of nuclear power plants – comparing with a subjective workload.  IEEE Trans Nucl Sci. 2006;  53 2962-2970
  CrossrefPubMedGoogle Scholar
• 25 Oginska H, Fafrowicz M, Golonka K et al. Chronotype, sleep loss, and diurnal pattern of salivary cortisol in a simulated daylong driving.  Chronobiology International. 2010;  27 959-974
  CrossrefPubMedGoogle Scholar
• 26 Carswell C M, Lio C H, Grant R et al. Hands-free administration of subjective workload scales: acceptability in a surgical training environment.  Appl Ergon. 2010;  42 138-145
  CrossrefPubMedGoogle Scholar
• 27 Levin S, France D J, Hemphill R et al. Tracking workload in the emergency department.  Hum Factors. 2006;  48 526-539
  CrossrefPubMedGoogle Scholar
• 28 Byers J C, Bittner A C, Hill S G. Traditional and raw task load index (TLX) correlations: are paired comparisons necessary?. In: Mital A, ed. Advances in industrial ergonomics and safety I.. London: Taylor & Francis; 1989: 481-485
  Google Scholar
• 29 Moroney W F, Biers D W, Eggemeier F T, Mitchell J A. A comparison of two scoring procedures with the NASA Task Load Index in a simulated flight task.  Proceedings of the IEEE. 1992;  2 734-740
  PubMedGoogle Scholar

C. C. ThompsonMD 

Brigham and Women’s Hospital
Division of Gastroenterology

75 Francis Street
Boston
MA 02115
USA

Fax: +1-617-264-6342

Email: ccthompson@partners.org