Gynecologic Cancer-related Lower Extremity LymphedemaNCT06920732
Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study
An observational study of Gynecologic Cancer-related Lower Extremity Lymphedema and Lymphedema, run by Zunyi Medical College at 1 site in China.
Trial summary
The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Gynecologic Cancer-related Lower Extremity Lymphedema, Lymphedema
- What is being tested?
- VLNT（Vascularized Lymph Node Transfer）, LVA（Lymphaticovenular Anastomosis） and LS（Liposuction）
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2023
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: From January 1st of 2018 to December 31th of 2023, 125 consecutive patients with secondary lower extremity lymphedema who underwent 3L(LVA+VLNT+LS) or 2L(LVA+LS or VLNT+LS) integrated surgical treatment were identified.
Who may be able to join
- The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.
- .Aged 18-90 years.
Who cannot join
- Lactation, for patients with pregnancy;
- Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;
- Disease history is less than 3 months;
- In patients with mental illness;
- Immunodeficiency patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003
About this study
The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:
Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?
Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.
- Being tested
- VLNT（Vascularized Lymph Node Transfer）, LVA（Lymphaticovenular Anastomosis）, LS（Liposuction）
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLNT（Vascularized Lymph Node Transfer）Procedure or surgery
VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis.
LVA（Lymphaticovenular Anastomosis）Procedure or surgery
LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically <0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema.
LS（Liposuction）Procedure or surgery
LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes.
| Study group | Role | What they receive |
|---|---|---|
| VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction) | This triple-modality intervention combines physiologic and debulking techniques. VLNT is performed to restore lymphatic function by transferring vascularized lymph nodes to the affected limb. LVA further facilitates lymphatic drainage by creating anastomoses between lymphatic vessels and nearby venules. LS is conducted to remove excess fibroadipose tissue and reduce limb volume. This comprehensive approach is hypothesized to provide synergistic and sustained benefits in severe or refractory lymphedema cases. Receives: Procedure: VLNT（Vascularized Lymph Node Transfer）; Procedure: LVA（Lymphaticovenular Anastomosis）; Procedure: LS（Liposuction） | |
| VLNT + LS (Vascularized Lymph Node Transfer + Liposuction) | This dual-modality intervention focuses on both physiologic restoration and volume reduction. VLNT is used to reconstruct lymphatic drainage pathways, while LS addresses tissue hypertrophy. This combination is selected for patients with poor lymphatic function and substantial limb volume increase, in whom LVA is not feasible due to lack of functional lymphatic vessels. Receives: Procedure: VLNT（Vascularized Lymph Node Transfer）; Procedure: LS（Liposuction） | |
| LVA + LS (Lymphaticovenular Anastomosis + Liposuction) | This approach combines a minimally invasive physiologic procedure (LVA) with LS. LVA promotes lymph flow by bypassing obstructed lymphatic channels, while LS removes accumulated fibrofatty tissue. It is suitable for patients with partially preserved lymphatic function and moderate limb volume increase. Receives: Procedure: LVA（Lymphaticovenular Anastomosis）; Procedure: LS（Liposuction） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb volume (mL) measured by circumference-based calculation
Each participant's lower limb circumference will be measured at predefined anatomical landmarks, and limb volume will be calculated using the truncated cone formula.
Measured: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Secondary outcomes (4)
Cellulitis Infection Rate (episodes/year)
The incidence of cellulitis episodes per patient was assessed through retrospective chart review and clinical records. A clinically diagnosed cellulitis episode was defined by acute onset of erythema, warmth, tenderness, and edema. We compared the mean episodes per year among different surgical approach groups.
Measured: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Change in Lymphoedema Quality of Life (LYMQOL) Score
Lymphedema-specific quality of life was measured using the LYMQOL questionnaire, which includes four domains: symptoms, emotions, function, and appearance. The total LYMQOL score was calculated and compared between preoperative and postoperative assessments in different surgical groups. We evaluated both within-group (pre-to-post) and between-group differences.
Measured: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Incidence of Surgical Complications
Surgical complications (e.g., flap infection, necrosis, lymphorrhea, or deep vein thrombosis) were assessed through postoperative clinical evaluations and chart review. Wound healing status was recorded, and the presence of any adverse events was documented.
Measured: Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)
Changes in Lymphoscintigraphy and Ultrasound Findings
Lymphoscintigraphy was performed to assess dermal backflow and collateral lymphatic vessel formation, while ultrasound evaluated lymph node and lymphatic vessels status (e.g., size, vascularity, viability). Postoperative changes were compared to baseline (preoperative) imaging in each group (LVA + VLNT + LS, VLNT + LS, LVA + LS).
Measured: Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Cancer-related Lower Extremity LymphedemaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deng Chengliang, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920732
- Sponsor's protocol ID
- KLLY-2024-093
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen J, Chen Z, Wu X, Li H, Xiao S, Wei Z, Zhang Y, Deng C. Integrated surgical treatment: a new model for treating secondary extremity lymphedema based on algorithms. Front Oncol. 2026 Jan 12;15:1676803. doi: 10.3389/fonc.2025.1676803. eCollection 2025.
PubMed 41602404
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06920732
- Acronym / sponsor ID
- KLLY-2024-093
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Apr 2025 (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.
The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:
Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?
Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction) | – | Procedure: VLNT（Vascularized Lymph Node Transfer）, Procedure: LVA（Lymphaticovenular Anastomosis）, Procedure: LS（Liposuction）This triple-modality intervention combines physiologic and debulking techniques. VLNT is performed to restore lymphatic function by transferring vascularized lymph nodes to the affected limb. LVA further facilitates lymphatic drainage by creating anastomoses between lymphatic vessels and nearby venules. LS is conducted to remove excess fibroadipose tissue and reduce limb volume. This comprehensive approach is hypothesized to provide synergistic and sustained benefits in severe or refractory lymphedema cases. |
| VLNT + LS (Vascularized Lymph Node Transfer + Liposuction) | – | Procedure: VLNT（Vascularized Lymph Node Transfer）, Procedure: LS（Liposuction）This dual-modality intervention focuses on both physiologic restoration and volume reduction. VLNT is used to reconstruct lymphatic drainage pathways, while LS addresses tissue hypertrophy. This combination is selected for patients with poor lymphatic function and substantial limb volume increase, in whom LVA is not feasible due to lack of functional lymphatic vessels. |
| LVA + LS (Lymphaticovenular Anastomosis + Liposuction) | – | Procedure: LVA（Lymphaticovenular Anastomosis）, Procedure: LS（Liposuction）This approach combines a minimally invasive physiologic procedure (LVA) with LS. LVA promotes lymph flow by bypassing obstructed lymphatic channels, while LS removes accumulated fibrofatty tissue. It is suitable for patients with partially preserved lymphatic function and moderate limb volume increase. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 1st of 2018 to December 31th of 2023, 125 consecutive patients with secondary lower extremity lymphedema who underwent 3L(LVA+VLNT+LS) or 2L(LVA+LS or VLNT+LS) integrated surgical treatment were identified.
Key inclusion criteria (2 listed)
- The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.
- .Aged 18-90 years.
Key exclusion criteria (5 listed)
- Lactation, for patients with pregnancy;
- Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;
- Disease history is less than 3 months;
- In patients with mental illness;
- Immunodeficiency patients.
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 |
|---|---|---|
| VLNT（Vascularized Lymph Node Transfer）VLNT is a physiologic surgical procedure in which vascularized lymph nodes are harvested from a donor site (e.g., groin or submental region) and transplanted to the affected limb to restore lymphatic drainage. The transferred lymph nodes are anastomosed to recipient vessels to ensure perfusion, aiming to reconstruct lymphatic flow and reduce lymphedema-related swelling and fibrosis. | Procedure or surgery | VLNT + LS (Vascularized Lymph Node Transfer + Liposuction), VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction) |
| LVA（Lymphaticovenular Anastomosis）LVA is a supermicrosurgical technique designed to improve lymphatic drainage by creating anastomoses between functional lymphatic vessels and nearby venules. Under high magnification, lymphatic vessels (typically <0.8 mm) are identified and connected to subdermal venules to bypass obstructed lymphatic pathways, facilitating improved lymph flow and symptom relief in patients with early-stage lymphedema. | Procedure or surgery | LVA + LS (Lymphaticovenular Anastomosis + Liposuction), VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction) |
| LS（Liposuction）LS is a volume-reduction procedure used in the management of advanced lymphedema characterized by fibroadipose tissue hypertrophy. Tumescent liposuction is performed to remove excess subcutaneous adipose tissue, thereby reducing limb volume and improving limb contour. This procedure is often combined with physiologic surgical techniques for optimal long-term outcomes. | Procedure or surgery | LVA + LS (Lymphaticovenular Anastomosis + Liposuction), VLNT + LS (Vascularized Lymph Node Transfer + Liposuction), VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction) |
Primary outcome
Change in lower limb volume (mL) measured by circumference-based calculation
Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Each participant's lower limb circumference will be measured at predefined anatomical landmarks, and limb volume will be calculated using the truncated cone formula.
4 secondary outcomes
Cellulitis Infection Rate (episodes/year)
Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Change in Lymphoedema Quality of Life (LYMQOL) Score
Time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Incidence of Surgical Complications
Time frame: Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)
Changes in Lymphoscintigraphy and Ultrasound Findings
Time frame: Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 41602404Chen J, Chen Z, Wu X, Li H, Xiao S, Wei Z, Zhang Y, Deng C. Integrated surgical treatment: a new model for treating secondary extremity lymphedema based on algorithms. Front Oncol. 2026 Jan 12;15:1676803. doi: 10.3389/fonc.2025.1676803. eCollection 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gynecologic Cancer-related Lower Extremity Lymphedema and Lymphedema, run by Zunyi Medical College at 1 site in China.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 10 Apr 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in lower limb volume (mL) measured by circumference-based calculation (time frame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920732, which also lists 1 linked publication.
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 10 Apr 2025.