Status:

UNKNOWN

Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging

Lead Sponsor:

University of Leeds

Collaborating Sponsors:

The Leeds Teaching Hospitals NHS Trust

University of Sheffield

Conditions:

Hepatectomy

Liver Failure

Eligibility:

All Genders

19-79 years

Brief Summary

Liver resection remains the only curative option for primary or metastatic liver cancer, but a more accurate prediction of post-hepatectomy liver failure (PHLF) is needed to further reduce morbidity a...

Detailed Description

OBJECTIVES (1) To determine if DGE-MRI can improve predictions of post-hepatectomy liver function; (2) To validate DGE-MRI based measurements of liver function against gold-standard liver function te...

Eligibility Criteria

Inclusion

  • Adults over 18 years of age and under 80 years
  • Referred to the hepatobiliary surgical service at St James's Hospital
  • Diagnosed with any hepatic tumour
  • One of:
  • i) Referred for liver resection (defined as two or more Couinaud segments) by multi-disciplinary team discussion at Saint James's Hospital (One stage arm) ii) OR Referred for PVE or ALPPS prior to likely major hepatectomy by multi-disciplinary team discussion at Saint James's Hospital (Two stage arm)

Exclusion

  • Unable to consent independently
  • Previous liver resection
  • Private patients
  • Concurrent malignancy unrelated to liver tumour
  • Chronic renal failure (estimated Glomerular Filtration Rate \< 30 mL/min)
  • Possible pregnancy
  • Other contraindications to DGE-MRI, including:
  • i) Cochlear Implant ii) Aneurysm Clips iii) Neurological stimulator iv) Implanted cardiac devices v) Metal heart valve vi) History of metal foreign bodies in orbits vii) Other implanted metal device which prevents MRI viii) Known allergy to Gadolinium contrast ix) Claustrophobia x) Weight exceeding 250 kg xi) Maximal diameter exceeding 55cm
  • Other contraindications to ICG i) Known allergy to Indocyanine green ii) Known allergy to sodium iodine iii) Known reaction or allergy to iodine iv) Previous diagnosis of a thyroid problem v) Breastfeeding

Key Trial Info

Start Date :

July 8 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2022

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT04705194

Start Date

July 8 2019

End Date

June 1 2022

Last Update

January 22 2021

Active Locations (1)

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1

The Leeds Teaching Hospital Trust

Leeds, United Kingdom