Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001116718
Ethics application status
Approved
Date submitted
2/10/2013
Date registered
4/10/2013
Date last updated
20/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Free lymph node transfer in the treatment of lymphoedema
Scientific title
In patients with upper limb lymphoedema, does free lymph node transfer from the groin, compared to conservative management, improve the limb circumference?
Secondary ID [1] 283340 0
nil
Universal Trial Number (UTN)
U1111-1146-4617
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lymphoedema 290234 0
Condition category
Condition code
Surgery 290625 290625 0 0
Surgical techniques
Cardiovascular 290642 290642 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288063 0
Treatment: Surgery
Comparator / control treatment
Conservative/standard lymphoedema care - this includes massage, bandaging and limb positioning as directed/provided by lymphoedema nurses and physiotherapists.
Control group
Active

Outcomes
Primary outcome [1] 290639 0
Reduction in limb circumference - this is measured by circumferential measurements of the limb at the ulnar styloid and 2 cm proximal to the elbow.
Timepoint [1] 290639 0
6 months
Secondary outcome [1] 304960 0
Quantify the change in limb circumference following this procedure - this is measured by circumferential measurements of the limb at the ulnar styloid and 2 cm proximal to the elbow. And compared to measurements prior to the procedure to create a percentage reduction.
Timepoint [1] 304960 0
6 months
Secondary outcome [2] 304961 0
Complication rates associated with the procedure - developing lymphoedema in the donor limb; necrotic lymph node grafts; infection; poor cosmesis.
All of these would be assessed by clinical examination at each follow up appointment.
Timepoint [2] 304961 0
6 months

Eligibility
Key inclusion criteria
stable lymphoedema in an upper limb, no further surgery required on that limb
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
smoking, BMI > 30, poorly controlled diabetes, comorbidities that could cause limb oedema eg. CHF, cirrhosis, low albumin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Pilot study to assess initial efficacy of technique.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/10/2013
Actual
10/10/2013
Date of last participant enrolment
Anticipated
Actual
5/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 5456 0
New Zealand
State/province [1] 5456 0

Funding & Sponsors
Funding source category [1] 288071 0
Hospital
Name [1] 288071 0
Waikato DHB
Country [1] 288071 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato DHB
Address
c/o Waikato Hospital
Pembroke St
Hamilton 3201
Country
New Zealand
Secondary sponsor category [1] 286794 0
None
Name [1] 286794 0
none
Address [1] 286794 0
Country [1] 286794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289999 0
Central HDEC
Ethics committee address [1] 289999 0
Ethics committee country [1] 289999 0
New Zealand
Date submitted for ethics approval [1] 289999 0
14/08/2013
Approval date [1] 289999 0
01/10/2013
Ethics approval number [1] 289999 0
13/CEN/117

Summary
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.
Trial website
Trial related presentations / publications
Currently submitted and being considered by ANZ Journal of Surgery for publication
Public notes

Contacts
Principal investigator
Name 43410 0
Mr Winston McEwan
Address 43410 0
c/o Waikato Hospital
Pembroke St
Hamilton 3201
Country 43410 0
New Zealand
Phone 43410 0
+64 7 839 8899
Fax 43410 0
Email 43410 0
[email protected]
Contact person for public queries
Name 43411 0
Dr Elizabeth Travis
Address 43411 0
c/o RMO Unit
Waikato Hospital
Pembroke St
Hamilton 3201
Country 43411 0
New Zealand
Phone 43411 0
+64 7 839 8899
Fax 43411 0
Email 43411 0
[email protected]
Contact person for scientific queries
Name 43412 0
Dr Elizabeth Travis
Address 43412 0
c/o RMO Unit
Waikato Hospital
Pembroke St
Hamilton 3201
Country 43412 0
New Zealand
Phone 43412 0
+64 7 839 8899
Fax 43412 0
Email 43412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLymph node grafting in the treatment of upper limb lymphoedema: a clinical trial.2015https://dx.doi.org/10.1111/ans.13171
N.B. These documents automatically identified may not have been verified by the study sponsor.