Endoscopy 2011; 43(5): 394-399
DOI: 10.1055/s-0030-1256241
Original article

© Georg Thieme Verlag KG Stuttgart · New York

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

K.  L.  Obstein1 , R.  S.  J.  Estépar2 , J.  Jayender3 , V.  D.  Patil3 , I.  S.  Spofford4 , M.  B.  Ryan5 , B.  I.  Lengyel2 , R.  Shams6 , K.  G.  Vosburgh2 , 3 , C.  C.  Thompson5
  • 1Division of Gastroenterology, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  • 2Surgical Planning Laboratory, Brigham and Women’s Hospital, Boston, Massachusetts, USA
  • 3Center for Integration of Medicine and Innovative Technology Image Guidance Laboratory, Massachusetts General Hospital, Boston, Massachusetts, USA
  • 4Division of Pediatric Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts, USA
  • 5Division of Gastroenterology, Brigham and Women’s Hospital, Boston, Massachusetts, USA
  • 6College of Engineering and Computer Science, Australian National University, Canberra, Australian Capital Territory, Australia
Further Information

Publication History

submitted 20 July 2010

accepted after revision 10 December 2010

Publication Date:
21 March 2011 (online)

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
  • 2 Vosburgh K G, Jolesz F A. The concept of image-guided therapy.  Acad Radiol. 2003;  10 176-179
  • 3 Brugge W R. Fine needle aspiration of pancreatic masses: the clinical impact.  Am J Gastroenterol. 2002;  97 2701-2702
  • 4 Kane R. Intraoperative ultrasonography: history, current state of the art, and future directions.  J Ultrasound Med. 2004;  23 1407-1420
  • 5 Rösch T, Lorenz R, Braig C et al. Endoscopic ultrasound in pancreatic tumor diagnosis.  Gastrointest Endosc. 1991;  37 347-352
  • 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
  • 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
  • 8 Ellsmere J, Stoll J, Wells 3rd W et al. A new visualization technique for laparoscopic ultrasonography.  Surgery. 2004;  136 84-92
  • 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
  • 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
  • 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
  • 12 Schwarz Y, Mehta A C, Ernst A et al. Electromagnetic navigation during flexible bronchoscopy.  Respiration. 2003;  70 516-522
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 27 Levin S, France D J, Hemphill R et al. Tracking workload in the emergency department.  Hum Factors. 2006;  48 526-539
  • 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
  • 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

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