Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema

Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphedema of Leg
• Intervention / Treatment: Procedure: implantation of hydrophobic tubes for edema fluid drainage; Device: Best Medical Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Faculdade de Medicina da Universidade do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Surgery + best medical treatment; The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.	Procedure: implantation of hydrophobic tubes for edema fluid drainage; 1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures.; Device: Best Medical Treatment; Compressive therapy, Phisioterapy, venous intervention
Active Comparator: Group 2: best medical treatment; This control group would receive only the best medical treatment available.	Device: Best Medical Treatment; Compressive therapy, Phisioterapy, venous intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower limb circumference in cm	Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee	Preoperative, six months, one year, second year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMS - Lymphedema quality of life	diseae specific qol questionnaire	preoperative, six months, one year, two years
PROMS - SF 36	Qol questionnaire	preoperative, six months, one year, two years
Lymphoscintigraphy	diagnostic exam	preoperative, one year (only in the intervention group)

Collaborators and Investigators

• Sponsor: Universidade do Porto

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lymphedema; quality of life; lower limb; edema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 300-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only principal Investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No