Short summary

This pilot study investigates and tests if we can correctly identify lymphatic vessels and venoles in close proximity to each other using comined ICG lymphography and ultra high frequency ultrasound for identification prior to lymphovenous anastomosis surgery.

Rationale

Late and long term sequelae following breast cancer treatment, such as lymphedema, affects patients quality of life due to many factors, amongst these are reduced functional ability due to affected shoulder and arm function, emotional problems and negative view on body image following treatment.

Lymphovenous anastomosis surgery seems promising in selected patient groups. The teqnique aims to re-establish the lymphatic flow, utilizing the patient's own lymphatic and venous vessels. The literature emphasized the importance of targeted surgery identifying the right vessels for anastomosis.

We therefore wish to investigate and test if we can correctly identify lymphatic vessels and venoles in close proximity to each other using comined ICG lymphography and ultra high frequency ultrasound for identification prior to lymphovenous anastomosis surgery. The number of preoperatively mapped lymphatic- and venous-vessels are compared to the number identified during surgey and used as our primary outcome.

Secondary outcome measures includes changes of arm volume, lymphatic pattern by ICG lymphography, health-related quality of life, lymphatic function and body composition prior to- and at 3 follow up three moths after surgery.

Description of the cohort

This study is designed as a hypothesis generating pilot study with a planned inclusion of 10 patients with a 3 months follow-up period. The study population is based upon patients who is already referred to the outpatient clinic at the Department of Plastic Surgery OUH for assessment of their upper-extremity lymphedema. Only patients who meet the inclusion criteria, will be informed and invited to participate in this trial by the examining physician. Patients with breast cancer related pitting-lymphedema in one of their upper extremities, who is above the age of 18 and capable of providing informed consent, is included. If pitting edema does not occur, the patient may not be included.

Data and biological material

Objective measured data will be collected by the primary investigator through pre- and post-operative examinations, patient journals and during operations.

Collected data provides the following for comparison before and 3 months after surgery:

1) The primary outcome is comparison of the number of lymph vessels and venoles found during surgery and the number originally planned.

2) Arm-volume measurements for each patient will form the basis for calculating the volume difference between the patient's arms. The volume difference before and after surgery will be compared. This applies to data collected from both manual measurements and water-displacement test.

3) Comparison of ICG lymphography video recordings before and 3 months after intervention, with changes in MD Anderson classification system of lymphedema.

4) Changes in LYMPH-Q scores for each individual scale from before and 3 months after intervention.

5) Changes in L-Dex score measured by stand-up bioimpedance before and 3 months after surgery.

6) Changes in measurements of body compositions before and 3 months after LVA surgery.

Collaborating researchers and departments

Department of Plastic Surgey, OUH

• Jens Ahm Sørensen
• Jørn Bo Thomsen