Clinical trial NCT05970068: Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema
Official title: Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphedema of Leg
Keywords: Lymphedema
quality of life
edema
lower limb
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once eligible patients have been identified, they would be randomized into one of two groups - the intervention group or the control group.

Randomization will help ensure that the two groups are comparable in terms of baseline characteristics, which can minimize the risk of bias in the study. The program used will be https://www.random.org/lists/.

Group 1: Surgery + best medical treatment The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage, in addition to the best medical treatment available.

Group 2: best medical treatment This control group would receive only the best medical treatment available.
Primary purpose: TREATMENT

Brief summary: Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.

Detailed description: Lymphedema is a chronic condition that affects the lymphatic system and accumulates protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur after surgery, trauma, radiation therapy, or infection and can cause significant physical, functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected limb can lead to difficulty with daily activities, decreased mobility, reduced quality of life, and increased susceptibility to infections (1).

Currently, the management of lymphedema involves both conservative and surgical approaches. Conservative treatment includes complex decongestive therapy, which combines manual lymphatic drainage, compression therapy, exercise, and skincare (reference here). While this approach can be effective, it requires long-term commitment and compliance from patients, which can be challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or vascularized lymph node transfer, are reserved for patients with mild to severe or refractory lymphedema with moderate results (2).

Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but these methods are not very effective.

In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one possible solution may be to create artificial pathways for edema fluid to flow away from the obstructed regions. This can be achieved through the subcutaneous implantation of silicone tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3).

In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region, creating channels for fluid to flow away from the obstructed areas to the non-obstructed regions, where absorption can take place.

The subcutaneous implantation of hydrophobic tubes is a minimally invasive procedure that has shown promising results in the management of obstructive lymphedema of the lower limbs.

In a group of 20 patients with obstructive lymphedema of the lower limbs that developed after lymphadenectomy and irradiation of the pelvis because of uterine cancer, this procedure was found to be effective after unsuccessful conservative therapy. The patients underwent the implantation of hydrophobic silicone tubes, followed by external compression using intermittent pneumatic compression and elastic support of tissues (3).

Overall, the implantation of hydrophobic tubes presents a promising alternative for managing obstructive lymphedema of the lower limbs. It has the potential to improve the quality of life for those who suffer from this condition, especially in advanced cases where other treatment options have failed. Further research is necessary to validate the efficacy of this approach and its long-term outcomes as well as to develop new bioengineered tubes for the drainage of lymphedematous extremities.

1. Vaillant L, Tauveron V. \[Primary lymphedema of limbs\]. Presse Med. 2010;39(12):1279-86.
2. Lee JW, Lee TY, Moon KC, You HJ, Kim DW. Lymphatic complex transfer as combined lymph vessel and node transfer for advanced stage upper extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2023.
3. Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015;3(4):401-8.
4. Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, et al. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021;21(1):188.
5. Nuri T, Iwanaga H, Otsuki Y, Ueda K. Lymphoscintigraphy for prediction of effect of lymphaticovenular anastomosis for treatment of secondary lower limb lymphedema. J Vasc Surg Venous Lymphat Disord. 2022;10(5):1079-86 e2.

Eligibility criteria: Inclusion Criteria:

* Lower limb lymphedema (Grade II-IV)
* Total occlusion at lymphoscintigraphy
* Patients treated at Centro Hospitalar Universitário de São João by the same surgical team
* Age \>18 years old;
* Lymphedema praecox
* Lower limb perimeter \>15% superior to contralateral limb

Exclusion Criteria:

* Secondary lymphedema
* Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)
* Acute infection of the limb
* Chronic venous insufficiency
* Neoplasic disease

Primary outcomes:
measure: Lower limb circumference in cm
timeFrame: Preoperative, six months, one year, second year
Secondary outcomes:
measure: PROMS - Lymphedema quality of life
timeFrame: preoperative, six months, one year, two years
measure: PROMS - SF 36
timeFrame: preoperative, six months, one year, two years
measure: Lymphoscintigraphy
timeFrame: preoperative, one year (only in the intervention group)
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculdade de Medicina da Universidade do Porto
Study officials:
References:
citation: Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):401-408. doi: 10.1016/j.jvsv.2015.05.001. Epub 2015 Jun 30.
citation: Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, Choi JY. Predictive role of lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity lymphedema: a preliminary study. BMC Med Imaging. 2021 Dec 8;21(1):188. doi: 10.1186/s12880-021-00713-1.