If a patient’s own blood is reinfused during major lifesaving cancer surgery, can modern technology reduce the risks of infection and cancer dissemination.

Does intraoperative cell salvage with a leucodepletion filter reduce the exposure risk to cancer cells and infection during pelvic exenteration surgery?

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12624000167561

Acronym

CIICS: Cancer and Infection dissemination following Intraoperative Cell Salvage, during pelvic exent

Enrollment

Registered

2024-02-22

Start date

2024-07-01

Completion date

2026-12-31

Last updated

2024-07-08

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

Conditions

None listed

Brief summary

Intraoperative cell salvage (ICS) is increasingly accepted as a safe alternative to allogeneic (donated) blood transfusion (ABT) with the potential to reduce ABT related adverse outcomes and improve immune competence. Remaining obstacles include: 1) the risk of systemic bacteraemia in the presence of bacterial contamination from the surgical field and 2) the potential risk of systemic cancer cell dissemination during surgery for malignant tumours. When considering these specific obstacles (i.e., cancer and bacterial contamination risks), pelvic exenteration surgery is of particular clinical interest. These procedures aim to cure patients with locally advanced adenocarcinoma. Major blood loss, requiring massive blood transfusion, often occur. However, considering the nature of the surgical field, potentially contaminated with cancer cells and bacteria (from bowel content), ICS is not used. The C-I-ICS study, aims to assess whether ICS (processing and filtering) could reduce the risks of cancer cell and bacterial dissemination, into the patient’s circulation, when used during curative pelvic exenteration surgery.

Interventions

Blood lost from the operating field during pelvic exenteration surgery is suctioned away and usually discarded. For this study the suctioned blood will be collected into an intraoperative cell salvage (ICS) machine. It will be heparinised, and collected into a reservoir, then processed via centrifugation in the ICS machine, then filtered via a leukodepletion filter. No blood will be returned to patients in this study. This study aims to analyse blood samples collected during ICS (before processi

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with colorectal cancer scheduled for pelvic exenteration surgery

Exclusion criteria

Patients who decline participation and consent. Patients who experience <800mL blood loss during surgery.

Outcome results