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