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Image Registered Gastroscopic Ultrasound (IRGUS) in Human Subjects: A Pilot Study to Assess Feasibility

1Division of Gastroenterology, Vanderbilt University Medical Center, Nashville, TN, USA.
2Surgical Planning Laboratory, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA.
3Center for Integration of Medicine and Innovative Technology Image Guidance Laboratory, Massachusetts General Hospital, Boston, MA, USA.
4Division of Pediatric Gastroenterology, Massachusetts General Hospital, Boston, MA, USA.
5Division of Gastroenterology, Brigham and Women’s Hospital, Boston, MA, USA.
6College of Engineering and Computer Science, Australian National University, Canberra, Australian Capital Territory, Australia.
Georg Thieme Verlag Stuttgart, New York
Publication Date:
Volume Number:
Issue Number:
Endoscopy. 2011 May;43(5):394-9.
PubMed ID:
Endosonography, Pancreatic Neoplasms, Three-Dimensional Imaging, Image-Guided Surgery
Appears in Collections:
P41 EB015898/EB/NIBIB NIH HHS/United States
P41 RR019703/RR/NCRR NIH HHS/United States
R25 CA089017/CA/NCI NIH HHS/United States
Generated Citation:
Obstein K.L., San Jose Estepar R., Jayender J., Patil V.D., Spofford I.S., Ryan M.B., Lengyel B.I., Shams R., Vosburgh K.G., Thompson C.C. Image Registered Gastroscopic Ultrasound (IRGUS) in Human Subjects: A Pilot Study to Assess Feasibility. Endoscopy. 2011 May;43(5):394-9. PMID: 21425041. PMCID: PMC4054821.
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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.

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