Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema (Biobridge)
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|ClinicalTrials.gov Identifier: NCT02734979|
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : July 15, 2021
Last Update Posted : October 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Lymphedema Edema||Device: Biobridge and lymph node transfer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema|
|Actual Study Start Date :||July 20, 2016|
|Actual Primary Completion Date :||July 7, 2018|
|Actual Study Completion Date :||October 29, 2020|
Experimental: Biobridge and lymph node transfer
The investigators will investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm. The investigators will perform lymph scans (lymphoscintigrams) before surgery and one year following surgery to determine the success of the surgery. In addition, the volume of the operated arm will be monitored by repeated measurement with a tape measure. The investigators will also track bioimpedance, a painless technique to detect fluid in the tissues. The investigators will obtain small skin biopsies and blood samples to detect the biological changes that may occur as a result of successful surgery.
Device: Biobridge and lymph node transfer
Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
- Change in Limb Volume [ Time Frame: 1 year ]Lymphoscintigraphy, a measure of limb volume indicative of adequate limb drainage, was conducted on the arm receiving BioBridge implantation (affected arm) and the contralateral (unaffected) arm, before surgery (baseline) and 1 year following surgical implantation of the Biobridge device. The outcome is reported as the median difference in the pre-implantation baseline value and the value 1 year after surgery for each arm.
- Serial Lymphoscintigraphy (LSG) [ Time Frame: 1 year ]Lymphoscintigraphy, a measure of limb volume for which changes are indicative of adequate limb drainage, was conducted on the arm receiving the BioBridge implantation (baseline) and 1 year following the Biobridge implantation. The outcome is reported as the median difference in measured volume for affected arm from baseline to 1 year.
- Bioimpedance Spectroscopy [ Time Frame: 1 year ]Bioimpedance spectroscopy (BIS) is a non-invasive technique to measure the volume of fluid in various parts of the body, and can be used to assess the extent of lymphedema. BIS involves passing an extremely low-strength electrical current through the area and measuring how the flow of the current is slowed by the fluid in the body, and is reported as Ri in ohms, meaning the resistance of the intracellular fluid. BIS was conducted on the arm with the BioBridge implant, at baseline and 1 year after surgery. The outcome is reported as the median difference between baseline and 1 year after surgery in the arm receiving the BioBridge implant.
- Caliper Skin-fold Thickness [ Time Frame: 1 year ]Skin fold thickness as measured by calipers was used as a measure of fluid retention. Skin fold thickness was measured at the upper arm, forearm, and back of the hand, at baseline and at 1 year following surgical implantation of the Biobridge device. An increase in skin thickness means increased fluid retention. The outcome is reported as the median difference of skin fold thickness in millimeters (mm) for each location on the arm receiving the BioBridge implant, from baseline to 1 year.
- Cutaneous Punch Biopsy of Skin [ Time Frame: 1 year ]Serial changes in histopathology will be determined via a blinded assessment of serial cutaneous punch biopsies specimens.
- Quality of Life for Limb Lymphoedema (LYMQOL) [ Time Frame: 1 year ]Quality-of-life was assessed using the LYMQOL survey, a 5-question survey for improved function, appearance, symptoms, mood, and overall QOL. Overall QoL was reported on a 10-point scale with 10 being best, and the other assessments were for disease impact on a 4-point response scale consisting of 1 (none), 2 (a little), 3 (quite a bit), 4 (a lot), with lower values representing minimal disease (lymphedema) impact on the parameter and higher values representing a greater negative effect on the parameter. The outcome is reported as the median.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734979
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Stanley G Rockson, MD||Stanford University|