Hepatic Histology and Metabolism Following Total Pancreatectomy and Pancreaticoduodenectomy

NCT03864744 | Unknown

• 1 other identifier: H-18010755
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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 procedures.

Conditions

Total Pancreatectomy; Pancreaticoduodenectomy; Pancreatic Diabetes; Non-Alcoholic Fatty Liver Disease; Metabolic Complication; Diabetes Mellitus

Keywords

liver biopsy; Lipid metabolism; Glucose metabolism; Postoperative complications; Pancreatic surgery

Outcome Measures

Primary Outcomes (1)

• Change in hepatic lipid content (steatosis) after total pancreatektomy or pancreaticoduodenectomy

  Evaluated by light microscopy of the liver biopsy

  Baseline and after 12 months.

Secondary Outcomes (19)

• Hepatic lipid content

  After 12 months

• Diagnosis and grade of steatohepatitis (steatosis, ballooning and lobular inflammation)

  Baseline and after 12 months.

• Fibrosis stage (Kleiner classification)

  Baseline and after 12 months.

• NAFLD activity score (NAS)

  Baseline and after 12 months.

• Liver steatosis

  After 12 months.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who undergo total pancreatectomy or pancreaticoduodenectomy at Rigshospitalet, Copenhagen.

You may qualify if:

• Subject scheduled for total pancreatectomy or pancreaticoduodenectomy
• Informed consent signed prior to any study-related procedure

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Postoperative Complications

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Krag Knop, Professor

  Steno Diabetes Center Copenhagen, Clinical metabolic physiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 6, 2019
• Study Start: January 30, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

DK (1)