Free lymph node transfer in the treatment of lymphoedema

In patients with upper limb lymphoedema, does free lymph node transfer from the groin, compared to conservative management, improve the limb circumference?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001116718

Enrollment

Registered

2013-10-04

Start date

2013-10-10

Completion date

2014-06-05

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

An interventional study to assess the viability of free lymph node transfer in the treatment of upper limb lymphoedema following axillary clearance. Our study hypothesises that lymph nodes act to move lymphatic fluid from the soft tissues into lymphatic vessels through the ‘pump effect’. The study hypothesises that vascular supply by diffusion is sufficient to facilitate this, and that microvascular transfer is not required for a reduction in lymphoedema.

Interventions

Free transfer of lymph nodes from groin to upper limb. This involves an incision in the groin with removal of up to 4 nodes under local anaesthetic. They will then be transplanted to the elbow or wrist of the affected limb. We estimate the duration of the procedure to be approx 60 mins.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

stable lymphoedema in an upper limb, no further surgery required on that limb

Exclusion criteria

smoking, BMI > 30, poorly controlled diabetes, comorbidities that could cause limb oedema eg. CHF, cirrhosis, low albumin

Outcome results