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Detection Rate of Liver Metastases With Contrast Enhanced Intraoperative Ultrasound Compared to Regular Imaging (CEIOUS-Liver)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522209
First Posted: January 31, 2012
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH
  Purpose
The study compares the established imaging techniques (CT, MRT, Contrast Ultrasound) with the new method of intraoperative contrast enhanced ultrasound to compare all methods for their rate of detection of colorectal liver metastasis.

Condition Intervention
Colon Cancer Liver Metastasis Contrast Enhances Intraoperative Ultrasound Imaging for Liver Cancer Imaging for Liver Metastasis Procedure: Liver Surgery Device: Contrast Enhanced Ultrasound Radiation: CT Scan (standard) Radiation: Primovist MRI (3 Tesla)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Value of Contrast Enhanced Intraoperative Ultrasound Compared to Preoperative CEUS, CT and MRT in the Treatment of Colorectal Liver Metastases.

Resource links provided by NLM:


Further study details as provided by Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH:

Primary Outcome Measures:
  • Detection of Liver Metastasis during Operation [ Time Frame: During Operation ]
    Intraoperative Rate of Detection of Liver Metastasis compared to preoperative Imaging Analysis


Secondary Outcome Measures:
  • Comparison of Detection Rate for Liver Metastases of all imaging modalities [ Time Frame: 1 Week after Operation ]
  • Comparison of Sensitivity of all imaging modalities [ Time Frame: one Year ]
  • Comparison of Specicivity of all imaging modalities [ Time Frame: one year ]

Enrollment: 59
Study Start Date: December 2011
Study Completion Date: January 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Liver Surgery
    R0 Resection of Liver Metastases after Planning with preoperative imaging data and comparison with intraoperative contrast enhanced ultrasound
    Device: Contrast Enhanced Ultrasound
    The contrast enhanced Ultrasound imaging is performed before and during the operation using Sonovue contrast agent (2.5ml iv preop, 4.5ml iv intraop)
    Radiation: CT Scan (standard)
    A staging CT of the liver/abdomen with the minimal possible dosage for aquiring sufficent triphasic data in a 64-line helical scan
    Radiation: Primovist MRI (3 Tesla)
    an MRI scan of the liver with Primovist contrast agent including late phase as addition to the preop staging according to the protocol
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent Age > 18 years All Patients presenting with Colorectal Liver Metastasis indicated for Liver Surgery in the study period

Exclusion Criteria:

  • No Informed Consent Possible Pregnancy Patients with hereditary diseases of the metabolic system Liver Cirrhosis CHILD B and C Renal Insufficiency defined as Kreatinin >2,5 mg/dl PAtients enrolled in other studies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522209


Locations
Germany
Asklepios Hospital Barmbek
Hamburg, Germany, 22291
Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
Investigators
Principal Investigator: Gregor A Stavrou, Dr.med Dpt. of General and Visceral Surgery, Asklepios Hospital Barmbek, Hamburg, Germany
  More Information

Publications:
Lupinacci R, Penna C, Nordlinger B. Hepatectomy for resectable colorectal cancer metastases--indicators of prognosis, definition of resectability, techniques and outcomes. Surg Oncol Clin N Am. 2007 Jul;16(3):493-506, vii-viii. Review.
Nordlinger B, Van Cutsem E, Rougier P, Köhne CH, Ychou M, Sobrero A, Adam R, Arvidsson D, Carrato A, Georgoulias V, Giuliante F, Glimelius B, Golling M, Gruenberger T, Tabernero J, Wasan H, Poston G; European Colorectal Metastases Treatment Group. Does chemotherapy prior to liver resection increase the potential for cure in patients with metastatic colorectal cancer? A report from the European Colorectal Metastases Treatment Group. Eur J Cancer. 2007 Sep;43(14):2037-45. Epub 2007 Sep 4. Review.
Oldhafer KJ, Högemann D, Stamm G, Raab R, Peitgen HO, Galanski M. [3-dimensional (3-D) visualization of the liver for planning extensive liver resections]. Chirurg. 1999 Mar;70(3):233-8. German.
Lang H, Radtke A, Hindennach M, Schroeder T, Frühauf NR, Malagó M, Bourquain H, Peitgen HO, Oldhafer KJ, Broelsch CE. Impact of virtual tumor resection and computer-assisted risk analysis on operation planning and intraoperative strategy in major hepatic resection. Arch Surg. 2005 Jul;140(7):629-38; discussion 638.
Ong KO, Leen E. Radiological staging of colorectal liver metastases. Surg Oncol. 2007 Jul;16(1):7-14. Epub 2007 May 11. Review.
Cervone A, Sardi A, Conaway GL. Intraoperative ultrasound (IOUS) is essential in the management of metastatic colorectal liver lesions. Am Surg. 2000 Jul;66(7):611-5.
Nakano H, Ishida Y, Hatakeyama T, Sakuraba K, Hayashi M, Sakurai O, Hataya K. Contrast-enhanced intraoperative ultrasonography equipped with late Kupffer-phase image obtained by sonazoid in patients with colorectal liver metastases. World J Gastroenterol. 2008 May 28;14(20):3207-11.
Scheele J, Stangl R, Altendorf-Hofmann A. Hepatic metastases from colorectal carcinoma: impact of surgical resection on the natural history. Br J Surg. 1990 Nov;77(11):1241-6.
Scheele J, Stang R, Altendorf-Hofmann A, Paul M. Resection of colorectal liver metastases. World J Surg. 1995 Jan-Feb;19(1):59-71.
Belghiti J, Hiramatsu K, Benoist S, Massault P, Sauvanet A, Farges O. Seven hundred forty-seven hepatectomies in the 1990s: an update to evaluate the actual risk of liver resection. J Am Coll Surg. 2000 Jul;191(1):38-46.
Benoist S, Nordlinger B. Neoadjuvant treatment before resection of liver metastases. Eur J Surg Oncol. 2007 Dec;33 Suppl 2:S35-41. Epub 2007 Nov 5. Review.
Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142. Review.
Folprecht G, Gruenberger T, Bechstein WO, Raab HR, Lordick F, Hartmann JT, Lang H, Frilling A, Stoehlmacher J, Weitz J, Konopke R, Stroszczynski C, Liersch T, Ockert D, Herrmann T, Goekkurt E, Parisi F, Köhne CH. Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncol. 2010 Jan;11(1):38-47. doi: 10.1016/S1470-2045(09)70330-4. Epub 2009 Nov 26.
Portier G, Elias D, Bouche O, Rougier P, Bosset JF, Saric J, Belghiti J, Piedbois P, Guimbaud R, Nordlinger B, Bugat R, Lazorthes F, Bedenne L. Multicenter randomized trial of adjuvant fluorouracil and folinic acid compared with surgery alone after resection of colorectal liver metastases: FFCD ACHBTH AURC 9002 trial. J Clin Oncol. 2006 Nov 1;24(31):4976-82.
Abdalla EK, Hicks ME, Vauthey JN. Portal vein embolization: rationale, technique and future prospects. Br J Surg. 2001 Feb;88(2):165-75. Review.
Wicherts DA, Miller R, de Haas RJ, Bitsakou G, Vibert E, Veilhan LA, Azoulay D, Bismuth H, Castaing D, Adam R. Long-term results of two-stage hepatectomy for irresectable colorectal cancer liver metastases. Ann Surg. 2008 Dec;248(6):994-1005. doi: 10.1097/SLA.0b013e3181907fd9.
Oldhafer KJ, Stavrou GA, Prause G, Peitgen HO, Lueth TC, Weber S. How to operate a liver tumor you cannot see. Langenbecks Arch Surg. 2009 May;394(3):489-94. doi: 10.1007/s00423-009-0469-9. Epub 2009 Mar 12.
Preim B, Bourquain H, Selle D, Oldhafer KJ. Resection Proposals for Oncologic Liver Surgery based on Vascular Territories. 2002 Mar. 8;
Robinson P. The early detection of liver metastases. Cancer Imaging. 2002;
Gaa J, Wieder H, Schwaiger M, Rummeny EJ. [Modern imaging for liver metastases from colorectal tumors]. Chirurg. 2005 Jun;76(6):525-6, 528-34. Review. German.
Bhattacharjya S, Bhattacharjya T, Baber S, Tibballs JM, Watkinson AF, Davidson BR. Prospective study of contrast-enhanced computed tomography, computed tomography during arterioportography, and magnetic resonance imaging for staging colorectal liver metastases for liver resection. Br J Surg. 2004 Oct;91(10):1361-9.
Konopke R, Kersting S, Bergert H, Bloomenthal A, Gastmeier J, Saeger HD, Bunk A. Contrast-enhanced ultrasonography to detect liver metastases : a prospective trial to compare transcutaneous unenhanced and contrast-enhanced ultrasonography in patients undergoing laparotomy. Int J Colorectal Dis. 2007 Feb;22(2):201-7. Epub 2006 May 30.
Shah AJ, Callaway M, Thomas MG, Finch-Jones MD. Contrast-enhanced intraoperative ultrasound improves detection of liver metastases during surgery for primary colorectal cancer. HPB (Oxford). 2010 Apr;12(3):181-7. doi: 10.1111/j.1477-2574.2009.00141.x.

Responsible Party: Dr. Gregor A. Stavrou, Principal Investigator, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT01522209     History of Changes
Other Study ID Numbers: Asklepios
First Submitted: January 3, 2012
First Posted: January 31, 2012
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Dr. Gregor A. Stavrou, Asklepios Kliniken Hamburg GmbH:
CRLM
Primovist MRI
CEIOUS

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics


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