Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

LYMPHA: Eliminating the Burden of Lymphedema in Patients Requiring Nodal Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03073096
Recruitment Status : Active, not recruiting
First Posted : March 8, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Lymphedema is the build-up of lymph fluid in the body's tissue causing chronic, debilitating swelling. This commonly occurs as a result of a disruption of the lymphatic system during lymph node dissection surgeries. In melanoma patients, the incidence of lymphedema ranges from 5-10% in the arms following an axillary dissection, and 28-40% in the legs following groin dissection. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an innovative microsurgical technique where blocked lymphatic vessels are drained into the blood circulation by surgically creating a shunt between a lymphatic channel and a blood vessel called a lymphatic-venous bypass. Recently, LYMPHA has been shown to prevent lymphedema when performed at the time of nodal dissection. We propose a prospective pilot study evaluating the practice of the LYMPHA technique for the primary prevention lymphedema at The Ottawa Hospital. The novel use of the LYMPHA technique holds the potential to prevent lymphedema rather than to attempt to treat it once it has already progressed and as a result will not only improve the quality of life of the cancer patients, but also decrease health care costs associated with treating lymphedema.

Condition or disease Intervention/treatment Phase
Lymph Node Disease Procedure: LVA at time of nodal dissection Not Applicable

Detailed Description:

Consenting patients will have the LYMPHA procedure at the time of planned axillary or groin dissection surgery for the prevention of upper and lower extremity lymphedema, respectively. The node dissection will be performed by Dr. Nessim, while the LYMPHA technique will be performed by the plastic surgeon, Dr. Momtazi, trained in microsurgical technique. The LYMPHA procedure consists of performing lymphatic-venous anastomoses (LVA) at the time of the node dissection. Patent blue dye will be injected into the patient approximately 10 minutes before skin incision. This will allow mapping of the lymphatic channels for identification for bypass. The node dissection will then be performed with preservation of the saphenous vein in the leg and the anterior branch of the axillary vein in the axilla. Afferent lymphatic vessels will be sutured into the saphenous vein or a branch of the axillary vein distal to a competent valve, respectively. The total duration of the surgery is approximately 3 hours. The LYMPHA technique accounts for an additional 30 minutes to the standard 2-2.5 hours allocated to the node dissection.

Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected limbs (arms or legs). Patients will be followed up clinically at every 3 months up to a year, and then again at the end of the second year (at the 24 month-mark only). At each follow-up visit, patients will have a physical examination and their circumferential limb measurements will be taken with measuring tape at three specific intervals up the limb. For example, patients undergoing an axillary dissection will have the circumference of their wrist taken, and then again 4 cm proximal to the wrist, then 8 cm proximal to the wrist, and so forth. The method will be used for the legs but starting at the ankle. Volume will be calculated indirectly, using Dr. Brorson's truncated cone method (13). Patients will also fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL) administered by the Clinical Research Coordinator pre- and post-surgery. Each patient will have a total of 2 years of participation time.

Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected limbs (arms or legs). Patients will be followed up clinically at every 3 months up to a year, and then again at the second year. At each follow-up visit, patients will have a physical examination and their circumferential limb measurements will be taken with measuring tape at three specific intervals up the limb. Patients will also fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL) administered pre- and post-surgery.

  1. Primary Objective: To evaluate the success rate of performing the LYMPHA procedure. Success is defined as a completed LYMPHA procedure i.e. successful LVA.
  2. Secondary Objective: To evaluate the feasibility of follow-up assessments i. establish the ability to obtain pre- and post- limb measurements ii. obtain limb-specific quality of life information iii. design a protocol for a randomized controlled trial comparing lymphedema rates in patients receiving a lymphadenectomy + lymphatic-venous bypass versus lymphadenectomy alone.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All melanoma and other skin cancers (merkel cell carcinoma, squamous cell carcinoma as well as sarcoma patients requiring a nodal dissection (groin or axillary) will be offered to have a LVA at time of nodal dissection to prevent lymphedema.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Performing a Lymphatic-venous Anastomosis at Time of Nodal Dissection in Patients Requiring Complete Axillary or Groin Dissection for the Prevention of Lymphedema
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Intervention arm
LVA at time of nodal dissection
Procedure: LVA at time of nodal dissection
Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection




Primary Outcome Measures :
  1. Difference in limb volume between surgery-affected and surgery-unaffected limb at baseline, 3, 6, 9, 12 and 24 months [ Time Frame: every 3 months up to a year, again at year 2 ]
    At each follow-up visit, patients will have a physical examination and their circumferential limb measurements will be taken with measuring tape at three specific intervals up the limb. For example, patients undergoing an axillary dissection will have the circumference of their wrist taken, and then again 4 cm proximal to the wrist, then 8 cm proximal to the wrist, and so forth. The method will be used for the legs but starting at the ankle. Volume will be calculated indirectly, using Dr. Brorson's truncated cone method.


Secondary Outcome Measures :
  1. Limb-lymphedema-specific Quality of life assessment at baseline, 3, 6, 9, 12 and 24 months through the LYMQOL questionnaire [ Time Frame: every 3 months up to a year, again at year 2 ]
    Patients will fill out a limb lymphedema-specific quality of life questionnaire (LYMQOL). This includes the LYMQOL-arm or the LYMQOL-leg.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary melanoma, soft tissue sarcoma, squamous cell carcinoma or merkel cell carcinoma of the trunk or chest.
  • Node-positive cancer requiring an axillary or groin lymphadenectomy

Exclusion Criteria:

  • Patients receiving a sentinel lymph node biopsy alone
  • Patients with a cancer on the upper or lower extremities are excluded (i.e. arms or legs).
  • Patients with established preoperative lymphedema
  • Patients with post-thrombotic syndrome, peripheral vascular disease
  • Pregnant patients

Information from the National Library of Medicine

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): NCT03073096


Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Carolyn Nessim, MD The Ottawa Hospital

Publications:

Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03073096     History of Changes
Other Study ID Numbers: 20170146 form 6131
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:
axillary nodal dissection
groin nodal dissection

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphedema
Lymphatic Diseases