Lymphatic ReconstructionNCT06650592
Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
An observational study of Lymphatic Reconstruction, run by University of Chicago at 1 site in United States.
Trial summary
Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Reconstruction
- What is being tested?
- All patients who were candidates for immediate lymphatic reconstruction (ILR)
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.
Who may be able to join
- All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University o Chicago
Chicago, Illinois, 60637
Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu
Carlisa Dixon, 773-834-4337, cdixon520@bsd.uchicago.edu
About this study
Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.
- Conditions
- Lymphatic Reconstruction
- Being tested
- All patients who were candidates for immediate lymphatic reconstruction (ILR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All patients who were candidates for immediate lymphatic reconstruction (ILR)Other
All patients who were candidates for immediate lymphatic reconstruction (ILR)
| Study group | Role | What they receive |
|---|---|---|
| All patients who were candidates for immediate lymphatic reconstruction (ILR) | All patients who were candidates for immediate lymphatic reconstruction (ILR) in the LYMPHA Database Receives: Other: All patients who were candidates for immediate lymphatic reconstruction (ILR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference
Measured: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on volume
Measured: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.
Measured: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.
Measured: 1 Day
Secondary outcomes (3)
the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)
This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)
Measured: 1 Day
the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)
Measured: 1 Day
the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
This is a 17 questionnaire that scales from unable to do it to not difficult.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start26 Nov 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic ReconstructionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Summer Hanson, MD, PhD, FACS, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650592
- Sponsor's protocol ID
- IRB24-1513
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
- ClinicalTrials.gov ID
- NCT06650592
- Acronym / sponsor ID
- IRB24-1513
- Conditions
- Lymphatic Reconstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients who were candidates for immediate lymphatic reconstruction (ILR) | – | Other: All patients who were candidates for immediate lymphatic reconstruction (ILR)All patients who were candidates for immediate lymphatic reconstruction (ILR) in the LYMPHA Database |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.
Key inclusion criteria (1 listed)
- All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All patients who were candidates for immediate lymphatic reconstruction (ILR)All patients who were candidates for immediate lymphatic reconstruction (ILR) | Other | All patients who were candidates for immediate lymphatic reconstruction (ILR) |
Primary outcome
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference
Time frame: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on volume
Time frame: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.
Time frame: 1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.
Time frame: 1 Day
3 secondary outcomes
the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)
Time frame: 1 Day
the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time frame: 1 Day
the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Summer Hanson, MD, PhD, FACS principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Reconstruction, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summer Hanson, MD, PhD, FACS ((773) 702-6302, sehanson@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference (time frame: 1 Day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.