Status:
UNKNOWN
Hepatic Histology and Metabolism Following Total Pancreatectomy and Pancreaticoduodenectomy
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborating Sponsors:
Rigshospitalet, Denmark
University of Copenhagen
Conditions:
Total Pancreatectomy
Pancreaticoduodenectomy
Eligibility:
All Genders
18-79 years
Brief Summary
The objective of the study is to investigate the development of NAFLD following total pancreatectomy and pancreaticoduodenectomy and to explore the histological and metabolic changes following the pro...
Detailed Description
After total pancreatectomy patients are treated with exogenous insulin and pancreatic enzyme supplementation in order to treat the endocrine and exocrine insufficiencies inherently occurring postopera...
Eligibility Criteria
Inclusion
- Subject scheduled for total pancreatectomy or pancreaticoduodenectomy
- Informed consent signed prior to any study-related procedure
Exclusion
- Known liver disease before total pancreatectomy or pancreaticoduodenectomy (excluding NAFLD)
- Severe co-morbid disease (besides from the indication for the pancreas surgery)
- Pregnancy
- Any condition that the investigator feels would interfere with the safety of the trial participation or the safety of the subject
- Metastatic disease
- Percutaneous liver biopsy exclusion criteria (to be evaluated before last visit)
- MR spectroscopy demonstrating lipid content \<2%
- Haemoglobin \<6 mmol/L
- INR \>1.5
- Trombocytes \<40 × 109/L
- Skin infection in area where biopsy will be sampled
Key Trial Info
Start Date :
January 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03864744
Start Date
January 30 2019
End Date
August 30 2022
Last Update
October 4 2021
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Hellerup, Denmark, 2900