Lymph LeakageNCT03683095
Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
An observational study of Lymph Leakage, run by Ottawa Hospital Research Institute.
Trial summary
BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymph Leakage
- What is being tested?
- Lymphovenous bypass
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-70 years) with International Society of Lymphology Stage I-II lymphedema of the upper or lower extremity will be eligible for lymphovenous bypass.
Who may be able to join
- 18-70 years.
- Lymphedema of the upper or lower extremity.
- International Society of Lymphology Stage I-II.
Who cannot join
- 1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.
About this study
BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control.
Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20.
The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.
- Conditions
- Lymph Leakage
- Being tested
- Lymphovenous bypass
- Keywords
- Lymphedema, Lymphovenous bypass
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphovenous bypassProcedure or surgery
Lymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada).
Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm.
Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required.
The surgery will be performed on an outpatient basis with no planned hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Lymphovenous bypass | Patients with extremity lymphedema treated with lymphovenous bypass. Receives: Procedure: Lymphovenous bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity volume (v)
Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.
Measured: Assessed preoperatively and 12-months postoperatively.
Secondary outcomes (1)
Quality of life assessment tool for lymphedema of the limbs (LYMQOL).
Quality of life assessment tool for lymphedema of the limbs.
Measured: Assessed preoperatively and 12-months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Apr 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Why it stopped: Insufficient resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph LeakageStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moein Momtazi, MD, Principal investigator, Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683095
- Sponsor's protocol ID
- 20180289-01H
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2018
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT03683095
- Acronym / sponsor ID
- 20180289-01H
- Conditions
- Lymph Leakage
- Keywords
- Lymphedema, Lymphovenous bypass
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 25 Sep 2018 (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.
BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control.
Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20.
The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphovenous bypass | – | Procedure: Lymphovenous bypassPatients with extremity lymphedema treated with lymphovenous bypass. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-70 years) with International Society of Lymphology Stage I-II lymphedema of the upper or lower extremity will be eligible for lymphovenous bypass.
Key inclusion criteria (3 listed)
- 18-70 years.
- Lymphedema of the upper or lower extremity.
- International Society of Lymphology Stage I-II.
Key exclusion criteria (1 listed)
- 1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.
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 |
|---|---|---|
| Lymphovenous bypassLymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada). Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm. Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required. The surgery will be performed on an outpatient basis with no planned hospital stay. | Procedure or surgery | Lymphovenous bypass |
Primary outcome
Extremity volume (v)
Time frame: Assessed preoperatively and 12-months postoperatively.
Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.
1 secondary outcome
Quality of life assessment tool for lymphedema of the limbs (LYMQOL).
Time frame: Assessed preoperatively and 12-months postoperatively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Lymph Leakage
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Blood Loss, Intensive Care
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. This study is not recruiting at the moment.
Moein Momtazi, MD principal investigator
Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Leakage, run by Ottawa Hospital Research Institute.
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 3 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: withdrawn, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extremity volume (v) (time frame: Assessed preoperatively and 12-months postoperatively.). 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 22 Sep 2022.