xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970068</url>
    </required_header>
    <id_info>
      <org_study_id>300-23</org_study_id>
      <nct_id>NCT05970068</nct_id>
    </id_info>
    <brief_title>Hydrophobic Tubes for Lymphedema</brief_title>
    <official_title>Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade do Porto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade do Porto</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional&#xD;
        treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes&#xD;
        shows promise, creating artificial drainage pathways. This approach proved effective in&#xD;
        managing obstructive lymphedema in lower limbs. Further research is needed to validate its&#xD;
        efficacy and explore long-term outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lymphedema is a chronic condition that affects the lymphatic system and accumulates&#xD;
        protein-rich fluid in the interstitial spaces of the affected limb. The condition can occur&#xD;
        after surgery, trauma, radiation therapy, or infection and can cause significant physical,&#xD;
        functional, and psychosocial impairment. The chronic swelling and fibrosis of the affected&#xD;
        limb can lead to difficulty with daily activities, decreased mobility, reduced quality of&#xD;
        life, and increased susceptibility to infections (1).&#xD;
  &#xD;
        Currently, the management of lymphedema involves both conservative and surgical approaches.&#xD;
        Conservative treatment includes complex decongestive therapy, which combines manual lymphatic&#xD;
        drainage, compression therapy, exercise, and skincare (reference here). While this approach&#xD;
        can be effective, it requires long-term commitment and compliance from patients, which can be&#xD;
        challenging (reference here). Surgical approaches, such as lymphaticovenular anastomosis or&#xD;
        vascularized lymph node transfer, are reserved for patients with mild to severe or refractory&#xD;
        lymphedema with moderate results (2).&#xD;
  &#xD;
        Liposuction has been used as a treatment for lower limb lymphedema. The traditional treatment&#xD;
        of lymphedema includes compression garments, exercise, and manual lymphatic drainage, but&#xD;
        these methods are not very effective.&#xD;
  &#xD;
        In advanced cases of lymphedema, where all main lymphatics vessels are obstructed, one&#xD;
        possible solution may be to create artificial pathways for edema fluid to flow away from the&#xD;
        obstructed regions. This can be achieved through the subcutaneous implantation of silicone&#xD;
        tubes, a novel method for draining edema fluid in obstructive lymphedema of limbs (3).&#xD;
  &#xD;
        In the lower limbs, the tubes are placed from the leg to the lumbar or hypogastric region,&#xD;
        creating channels for fluid to flow away from the obstructed areas to the non-obstructed&#xD;
        regions, where absorption can take place.&#xD;
  &#xD;
        The subcutaneous implantation of hydrophobic tubes is a minimally invasive procedure that has&#xD;
        shown promising results in the management of obstructive lymphedema of the lower limbs.&#xD;
  &#xD;
        In a group of 20 patients with obstructive lymphedema of the lower limbs that developed after&#xD;
        lymphadenectomy and irradiation of the pelvis because of uterine cancer, this procedure was&#xD;
        found to be effective after unsuccessful conservative therapy. The patients underwent the&#xD;
        implantation of hydrophobic silicone tubes, followed by external compression using&#xD;
        intermittent pneumatic compression and elastic support of tissues (3).&#xD;
  &#xD;
        Overall, the implantation of hydrophobic tubes presents a promising alternative for managing&#xD;
        obstructive lymphedema of the lower limbs. It has the potential to improve the quality of&#xD;
        life for those who suffer from this condition, especially in advanced cases where other&#xD;
        treatment options have failed. Further research is necessary to validate the efficacy of this&#xD;
        approach and its long-term outcomes as well as to develop new bioengineered tubes for the&#xD;
        drainage of lymphedematous extremities.&#xD;
  &#xD;
          1. Vaillant L, Tauveron V. [Primary lymphedema of limbs]. Presse Med. 2010;39(12):1279-86.&#xD;
  &#xD;
          2. Lee JW, Lee TY, Moon KC, You HJ, Kim DW. Lymphatic complex transfer as combined lymph&#xD;
             vessel and node transfer for advanced stage upper extremity lymphedema. J Vasc Surg&#xD;
             Venous Lymphat Disord. 2023.&#xD;
  &#xD;
          3. Olszewski WL, Zaleska M. A novel method of edema fluid drainage in obstructive&#xD;
             lymphedema of limbs by implantation of hydrophobic silicone tubes. J Vasc Surg Venous&#xD;
             Lymphat Disord. 2015;3(4):401-8.&#xD;
  &#xD;
          4. Kwon HR, Hwang JH, Mun GH, Hyun SH, Moon SH, Lee KH, et al. Predictive role of&#xD;
             lymphoscintigraphy undergoing lymphovenous anastomosis in patients with lower extremity&#xD;
             lymphedema: a preliminary study. BMC Med Imaging. 2021;21(1):188.&#xD;
  &#xD;
          5. Nuri T, Iwanaga H, Otsuki Y, Ueda K. Lymphoscintigraphy for prediction of effect of&#xD;
             lymphaticovenular anastomosis for treatment of secondary lower limb lymphedema. J Vasc&#xD;
             Surg Venous Lymphat Disord. 2022;10(5):1079-86 e2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.&#xD;
  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/.&#xD;
  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.&#xD;
  Group 2: best medical treatment This control group would receive only the best medical treatment available.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lower limb circumference in cm</measure>
      <time_frame>Preoperative, six months, one year, second year</time_frame>
      <description>Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PROMS - Lymphedema quality of life</measure>
      <time_frame>preoperative, six months, one year, two years</time_frame>
      <description>diseae specific qol questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PROMS - SF 36</measure>
      <time_frame>preoperative, six months, one year, two years</time_frame>
      <description>Qol questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lymphoscintigraphy</measure>
      <time_frame>preoperative, one year (only in the intervention group)</time_frame>
      <description>diagnostic exam</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Lymphedema of Leg</condition>
    <arm_group>
      <arm_group_label>Group 1: Surgery + best medical treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: best medical treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This control group would receive only the best medical treatment available.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>implantation of hydrophobic tubes for edema fluid drainage</intervention_name>
      <description>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.</description>
      <arm_group_label>Group 1: Surgery + best medical treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Best Medical Treatment</intervention_name>
      <description>Compressive therapy, Phisioterapy, venous intervention</description>
      <arm_group_label>Group 1: Surgery + best medical treatment</arm_group_label>
      <arm_group_label>Group 2: best medical treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Lower limb lymphedema (Grade II-IV)&#xD;
  &#xD;
            -  Total occlusion at lymphoscintigraphy&#xD;
  &#xD;
            -  Patients treated at Centro Hospitalar Universitário de São João by the same surgical&#xD;
               team&#xD;
  &#xD;
            -  Age &gt;18 years old;&#xD;
  &#xD;
            -  Lymphedema praecox&#xD;
  &#xD;
            -  Lower limb perimeter &gt;15% superior to contralateral limb&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Secondary lymphedema&#xD;
  &#xD;
            -  Congenital lymphedema (Milroy, Meige, Klinefelter, Noonan, and Turner syndromes)&#xD;
  &#xD;
            -  Acute infection of the limb&#xD;
  &#xD;
            -  Chronic venous insufficiency&#xD;
  &#xD;
            -  Neoplasic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculdade de Medicina da Universidade do Porto</name>
        <address>
          <city>Porto</city>
          <zip>4200-319</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <reference>
      <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>
      <PMID>26992618</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34879819</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade do Porto</investigator_affiliation>
      <investigator_full_name>João Rocha Neves</investigator_full_name>
      <investigator_title>MD, MPH, PHD, FEBVS</investigator_title>
    </responsible_party>
    <keyword>Lymphedema</keyword>
    <keyword>quality of life</keyword>
    <keyword>edema</keyword>
    <keyword>lower limb</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphedema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>only principal Investigators</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970068
  org study id: 300-23
  nct id: NCT05970068
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: None (Open Label)
  measure: Lower limb circumference in cm
  time frame: Preoperative, six months, one year, second year
  description: Lower limb circumference in cm - ankle, calf 15 cm below the knee; knee; thigh 15 cm above the knee
  measure: PROMS - Lymphedema quality of life
  time frame: preoperative, six months, one year, two years
  description: diseae specific qol questionnaire
  measure: PROMS - SF 36
  time frame: preoperative, six months, one year, two years
  description: Qol questionnaire
  measure: Lymphoscintigraphy
  time frame: preoperative, one year (only in the intervention group)
  description: diagnostic exam
  arm group label: Group 1: Surgery + best medical treatment
  arm group type: Experimental
  description: The intervention group would receive the novel treatment of implantation of hydrophobic tubes for edema fluid drainage and the best medical treatment available.
  arm group label: Group 2: best medical treatment
  arm group type: Active Comparator
  description: This control group would receive only the best medical treatment available.
  intervention type: Procedure
  intervention name: implantation of hydrophobic tubes for edema fluid drainage
  description: 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.
  arm group label: Group 1: Surgery + best medical treatment
  intervention type: Device
  intervention name: Best Medical Treatment
  description: Compressive therapy, Phisioterapy, venous intervention
  arm group label: Group 1: Surgery + best medical treatment
  arm group label: Group 2: best medical treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Portugal
  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.
  PMID: 26992618
  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.
  PMID: 34879819
  responsible party type: Principal Investigator
  investigator affiliation: Universidade do Porto
  investigator full name: João Rocha Neves
  investigator title: MD, MPH, PHD, FEBVS
  mesh term: Lymphedema
  sharing ipd: No
  ipd description: only principal Investigators