May the Risk of PHLF be Predicted With Preoperative Liver Gadoxetate MRI

NCT04692259 | Unknown

• 1 other identifier: 2020-05708
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 7

Brief Summary

Post hepatectomy liver failure (PHLF) is one of the most severe complications after liver re-section. Preoperative evaluation of liver function is complicated and imprecise. The volume and function needed for each individual patient is unknown and the methods used for evaluation are uncertain. Preoperative MRI with Gadolinium may give dynamic information regarding liver function correlating with postoperative liver failure. A retrospective analysis will be performed regarding this topic.

Conditions

MRI; Liver Resection; Liver Failure as A Complication of Care

Keywords

MRI; Postoperative liver failure; Gadolinium; Liver resection

Outcome Measures

Primary Outcomes (1)

• Contrast dynamics of Gadoxetate MRI correlation with the risk of PHLF.

  MRI dynamics correlation with postoperative liver failure. Measurement of gadoxetate uptake pattern in the liver and correlation of this pattern to the risk of developing post hepatectomy liver failure.

  2 years

Secondary Outcomes (2)

• Correlation between preoprative and postoperative risk factors and PHLF

  2 years

• MRI protocol description report on method used MRI protocol description

  [Time Frame: 2 years

Study Arms (1)

experimental arm

EXPERIMENTAL

Single arm study. All patient who had an MRI performed before liver resection is included

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Liver MRI before liver resection

experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have had a Primovist MRI within 8 weeks before hemihepatectomy or extended hemi-hepatectomy +/- bile duct anastomosis independent of diagnosis.
• Patients with cirrhosis who have had a Primovist MRI within 8 weeks before resection of more than one liver segment
• Patients who had liver volume augmentation with a pre-operative Primovist MRI less than 2 weeks before resection
• Patients who have had a Primovist MRI within 6 weeks be-fore any liver resection where PHLF or death within 90 days occurred.

You may not qualify if:

• \<18 years of age
• Resection was not performed -

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (7)

Rikshospitalet

Copenhagen, Denmark

RECRUITING

Helsingfors Universitetssjukhus

Helsinki, Finland

RECRUITING

Rikshospitalet

Oslo, Norway

RECRUITING

Karolinska Universitetssjukhuset Huddinge

Stockholm, Södermanland County, Sweden

RECRUITING

Sahlgrenska sjukhuset

Gothenburg, Sweden

RECRUITING

Akademiska sjukhuset

Uppsala, Sweden

RECRUITING

Per Sandström

Linköping, Östergötland County, 58185, Sweden

RECRUITING

Related Publications (11)

• Sultana A, Brooke-Smith M, Ullah S, Figueras J, Rees M, Vauthey JN, Conrad C, Hugh TJ, Garden OJ, Fan ST, Crawford M, Makuuchi M, Yokoyama Y, Buchler M, Padbury R. Prospective evaluation of the International Study Group for Liver Surgery definition of post hepatectomy liver failure after liver resection: an international multicentre study. HPB (Oxford). 2018 May;20(5):462-469. doi: 10.1016/j.hpb.2017.11.007. Epub 2017 Dec 26.

  PMID: 29287736 RESULT

• Shindoh J, Tzeng CW, Aloia TA, Curley SA, Zimmitti G, Wei SH, Huang SY, Mahvash A, Gupta S, Wallace MJ, Vauthey JN. Optimal future liver remnant in patients treated with extensive preoperative chemotherapy for colorectal liver metastases. Ann Surg Oncol. 2013 Aug;20(8):2493-500. doi: 10.1245/s10434-012-2864-7. Epub 2013 Feb 3.

  PMID: 23377564 RESULT

• Abdalla EK, Adam R, Bilchik AJ, Jaeck D, Vauthey JN, Mahvi D. Improving resectability of hepatic colorectal metastases: expert consensus statement. Ann Surg Oncol. 2006 Oct;13(10):1271-80. doi: 10.1245/s10434-006-9045-5. Epub 2006 Sep 6. No abstract available.

  PMID: 16955381 RESULT

• Guiu B, Chevallier P, Denys A, Delhom E, Pierredon-Foulongne MA, Rouanet P, Fabre JM, Quenet F, Herrero A, Panaro F, Baudin G, Ramos J. Simultaneous trans-hepatic portal and hepatic vein embolization before major hepatectomy: the liver venous deprivation technique. Eur Radiol. 2016 Dec;26(12):4259-4267. doi: 10.1007/s00330-016-4291-9. Epub 2016 Apr 18.

  PMID: 27090112 RESULT

• Guiu B, Quenet F, Escal L, Bibeau F, Piron L, Rouanet P, Fabre JM, Jacquet E, Denys A, Kotzki PO, Verzilli D, Deshayes E. Extended liver venous deprivation before major hepatectomy induces marked and very rapid increase in future liver remnant function. Eur Radiol. 2017 Aug;27(8):3343-3352. doi: 10.1007/s00330-017-4744-9. Epub 2017 Jan 18.

  PMID: 28101681 RESULT

• de Graaf W, van Lienden KP, van den Esschert JW, Bennink RJ, van Gulik TM. Increase in future remnant liver function after preoperative portal vein embolization. Br J Surg. 2011 Jun;98(6):825-34. doi: 10.1002/bjs.7456. Epub 2011 Apr 11.

  PMID: 21484773 RESULT

• Sparrelid E, Jonas E, Tzortzakakis A, Dahlen U, Murquist G, Brismar T, Axelsson R, Isaksson B. Dynamic Evaluation of Liver Volume and Function in Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy. J Gastrointest Surg. 2017 Jun;21(6):967-974. doi: 10.1007/s11605-017-3389-y. Epub 2017 Mar 10.

  PMID: 28283924 RESULT

• Cieslak KP, Bennink RJ, de Graaf W, van Lienden KP, Besselink MG, Busch OR, Gouma DJ, van Gulik TM. Measurement of liver function using hepatobiliary scintigraphy improves risk assessment in patients undergoing major liver resection. HPB (Oxford). 2016 Sep;18(9):773-80. doi: 10.1016/j.hpb.2016.06.006. Epub 2016 Jul 25.

  PMID: 27593595 RESULT

• Olthof PB, Tomassini F, Huespe PE, Truant S, Pruvot FR, Troisi RI, Castro C, Schadde E, Axelsson R, Sparrelid E, Bennink RJ, Adam R, van Gulik TM, de Santibanes E. Hepatobiliary scintigraphy to evaluate liver function in associating liver partition and portal vein ligation for staged hepatectomy: Liver volume overestimates liver function. Surgery. 2017 Oct;162(4):775-783. doi: 10.1016/j.surg.2017.05.022. Epub 2017 Jul 18.

  PMID: 28732555 RESULT

• Rassam F, Zhang T, Cieslak KP, Lavini C, Stoker J, Bennink RJ, van Gulik TM, van Vliet LJ, Runge JH, Vos FM. Comparison between dynamic gadoxetate-enhanced MRI and 99mTc-mebrofenin hepatobiliary scintigraphy with SPECT for quantitative assessment of liver function. Eur Radiol. 2019 Sep;29(9):5063-5072. doi: 10.1007/s00330-019-06029-7. Epub 2019 Feb 22.

  PMID: 30796575 RESULT

• Theilig D, Steffen I, Malinowski M, Stockmann M, Seehofer D, Pratschke J, Hamm B, Denecke T, Geisel D. Predicting liver failure after extended right hepatectomy following right portal vein embolization with gadoxetic acid-enhanced MRI. Eur Radiol. 2019 Nov;29(11):5861-5872. doi: 10.1007/s00330-019-06101-2. Epub 2019 Mar 21.

  PMID: 30899977 RESULT

Study Officials

• Per Sandström, Prof

  Academic study

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Sandström, Prof

CONTACT

+46734058581; per.sandstrom@liu.se

Bergthor Bjornsson, MD PhD

CONTACT

+46101033666; bergthor.bjornsson@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Retrospective analysis of correlation between MRI dynamics and the risk of postoperative liver failure after liver resection.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: December 29, 2020
• Primary Completion: February 28, 2024
• Study Completion: June 30, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

SE (4); FI (1); NO (1); DK (1)