To investigate the acute inflammatory response in patients undergoing oncological surgery in which the splenic nerve bundle is exposed.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mapping of the systemic inflammatory response, as measured by means of
pro-inflammatory cytokines, protein and transcript expression. Cytometric bead
array will be used to identify important pro-inflammatory cytokines, amongst
which most likely TNF-alpha, interferon gamma and interleukins such as IL-1,
IL-6, IL-8, and IL-10. These cytokines will be analyzed in more detail using
assays such as Enzyme Linked ImmunoSorbent Assay (ELISA) and by means of
Polymerase Chain Reaction (PCR) for transcript expression.
Secondary outcome
- the effect of ex vivo lipopolysaccharide (LPS) stimulations on the Toll-like
receptor (TLR) responses of monocytes in these patients.
- the effect on the local pro- and anti-inflammatory responses in splenic
tissue in patients undergoing pancreaticosplenectomy (RAMPS procedure).
- the presence of nerve fibres in the gastrosplenic ligament in patients
undergoing pancreaticosplenectomy or esophagectomy.
Background summary
An acute, increased inflammatory response after surgery is associated with the
occurrence of postoperative complications. Furthermore, a chronic inflammation
lies at the basis of diseases such as inflammatory bowel diseases (IBD) and
rheumatoid arthritis (RA), for which a definite therapeutic therapy is still
needed. In experimental studies, we showed that neurostimulation of sympathetic
nerve fibres reduces both local and systemic inflammation in preclinical models
of IBD. In a future study, we want to investigate the effects of stimulation of
splenic nerve fibres on acute, systemic inflammation during oncological surgery
in which the splenic nerve bundle is exposed as part of the procedure. However,
the effect of the operational procedures and exposure of the splenic nerve on
the acute inflammatory response is not well known.
Study objective
To investigate the acute inflammatory response in patients undergoing
oncological surgery in which the splenic nerve bundle is exposed.
Study design
A pilot study, in which the acute inflammatory response is investigated during
oncological surgery in which the splenic nerve bundle is exposed. No additional
interventions will be performed.
Study burden and risks
Blood samples will be collected at several predefined moments in relation to
the moment of incision. Splenic tissue samples will only be collected and
analyzed in patients undergoing pancreaticosplenectomy, in which the spleen is
removed as part of the procedure.
MIchelangelolaan 2
Eindhoven 5623 EJ
NL
MIchelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
- Subjects who undergo elective surgery in which the splenic artery is exposed as part of the procedure
- Written informed consent
- Older than 18 years
Exclusion criteria
- Previous splenectomy
- Use of steroids 4 weeks prior to inclusion
- Use of immunosuppresive agents (e.g. methotrexate, biologicals)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56549.100.16 |