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

NCT ID: NCT03073096

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-06-03

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.

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.

Conditions

Lymph Node Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention arm

LVA at time of nodal dissection

Group Type: OTHER

LVA at time of nodal dissection

Intervention Type: PROCEDURE

Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection

Interventions

LVA at time of nodal dissection

Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn Nessim, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

20170146 form 6131

Identifier Type: -

Identifier Source: org_study_id