Investigating methods of reducing cancer recurrence by changing tissue drainage systems at the time of operation.

In patients with cervical and prostate cancer, does a patient’s normal lower limb lymphatic flow rate slow after the introduction of a lower limb sympathetic blockade via a spinal anaesthetic?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612001162808

Acronym

Nil

Enrollment

Registered

2012-11-01

Start date

2014-04-01

Completion date

2014-12-15

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The body’s lymphatics vessels have an important function and move fluid outside blood vessels through lymph glands. This role in ‘clean up’ of cell debris after surgery is very important to understand as these lymphatic channels are also mechanisms of spread of cancer cells. Lymph glands are a common site where cancer recurs after surgery. There is evidence to suggest that the movement of lymph through lymphatic channels alters under epidural/spinal anaesthesia. These sorts of anaesthesia techniques are sometimes performed at the time of surgery for pain relief; this study will consider whether they also have a role in the reduction of lymph flow at the time of surgery. Doctors may therefore be able to utilise another technique to reduce the risk of cancer recurrence after surgery. Primary research hypothesis: Lymphatic flow in the lower limb is reduced by sympathetic blockade (spinal anaesthesia).

Interventions

An assessment of the speed of a participant’s lymphatic flow rates is made using lymphoscintigraphy - a baseline measurement is established. Two weeks later, a spinal anaesthetic is performed (the exposure). The spinal anaesthetic provides complete sympathetic blockade to the lower limbs. Immediately following the exposure, a second lymphoscintigram is performed and the results are compared. 1. Both of the lymphoscintigrams are performed over two hours. A 0.4ml bleb of colloid tracer is injected between the first and second toes. The passage of the colloid flow up the leg is followed using gamma camera imaging. The patient lies flat through this procedure. The transient discomfort of the injection is the only harm to the patient. We have received ethics approval for the use of the (harmless) low dose radio-isotope injection. 2. The spinal anaesthestic is routinely performed for these patients as they are receiving brachytherapy that requires applicator insertion into the cervix or prostate. The lymphoscintigraphy is being performed after the procedure has been completed, but with the spinal anaesthetic still active. A typical spinal anaesthetic dose is 12miligrams of intrathecal bupivicaine and 20micrograms of intrathecal Fentanyl.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Patients presenting for brachytherapy for cervical or prostatic carcinoma at Peter MacCallum Cancer Centre; - Patients requiring Magnetic Resonance Imaging after first treatment (and hence requiring a spinal anaesthetic).

Exclusion criteria

- Abnormal pre-existing lymph flow or sympathetic tone including: Complex Regional Pain Syndrome (CRPS), lymphoedema of any cause, surgery or trauma to the lower extremities and any cutaneous or sub cutaneous inflammation in the lower extremities; - Obesity as defined BMI >30kg/m2; - Diabetes Mellitus (type 1 and 2); - Patients currently on beta blockers or alpha antagonists; - Clinically or otherwise (Ultrasound) demonstrated lymphadenopathy; - Absent motor block prior to performing second lymphoscintigram; - Acute use of Non-Steroidal Anti-Inflammatory Drugs (last 24hours) preceding lymphoscintigram.

Outcome results