Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants greater than or equal to 18 years of age.
Participants willing to participate.
Participants able to complete informed consent.
Participants with a diagnosis of Melanoma undergoing ALND or ILND.
Disqualifiers
Participant staking anticoagulants within 7 days prior to surgery.
Participants that are known to be pregnant at the time of surgery.
Participants with BMI greater than 50.0
Trial design
Design model
Single group
Treatments tested in this trial
Lymphovenous bypass (LVB)
Procedure/SurgeryAt the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Upper extremity group recieving ALNDExperimental treatment 1 intervention
Group B: Lower extremity group getting ILNDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov