The effect of upper gastrointestinal surgery on the acute systemic inflammatory response

The effect of upper gastrointestinal surgery on the acute systemic inflammatory response - preSPLENIUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46239

Enrollment

Registered

2016-05-27

Start date

2016-07-19

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune response inflammatory response

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Previous splenectomy - Use of steroids 4 weeks prior to inclusion - Use of immunosuppresive agents (e.g. methotrexate, biologicals)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Netherlands

Outcome results