Pancreatic Cancer Clinical Trial
Official title:
Glycocalyx Levels in Patients Undergoing Pancreatectomy With Human Albumin 5% vs. Gelofusine
Background:
On the surface of every healthy cellular membrane resides a layer known as the glycocalyx.
This structure consists of extracellular domains of receptor, adhesion and transmembrane
molecules such as syndecan-1 covalently bound to highly negatively charged
glycosaminoglycans, heparan sulfates. It has a principal role to maintain wall integrity,
avoid inflammation and tissue oedema in vessels but in contrast, glycocalyx is robust and
elevated on cancer cells. This study examines whether the endothelial glycocalyx layer is
preserved in patients undergoing pancreatectomy with human albumin 5% vs. gelofusine in a
restrictive goal directed fluid regime perioperatively for the first 24hours. Degradation of
glycocalyx will be investigated by analyzing basic levels of the core protein syndecan-1 and
heparan sulfates with post-operative samples.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - ASA 1-3 - patients aged between 18-75 years old with written informed consent Exclusion Criteria: - Patients who refuse to participate, - Have severe congestive heart failure (NYHA class III/IV) or severe respiratory disease (PaO2/FiO2 < 200), - Suffer significant renal or hepatic dysfunction (creatinine raised >50 % or liver enzymes >50 % of normal values), - Pregnant - Allergic to gelofusine and human albumin |
Country | Name | City | State |
---|---|---|---|
Malaysia | Anaesthesia Department, Faculty of Medicine, University Malaya | Kuala Lumpur | Federal Territory |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurence of pancreatic fistula leak | Review will be done according to guideline of Revised 2016 International Study Group on Pancreatic Fistula (ISGPF) | Within post-op 30 days | |
Primary | Changes in serum syndecan 1 concentrations | Blood samples are collected to check for syndecan 1 concentrations in serum | Within post-op 7 days | |
Primary | Changes in serum heparan sulfate concentrations | Blood samples are collected to check for heparan sulfate concentrations in serum | Within post-op 7 days | |
Secondary | Changes in levels of Inflammatory markers Interleukin-1 and CRP | Blood samples are collected to check level of the Inflammatory markers Interleukin-1 and CRP | Within post-op 7 days |
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