Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study

NCT06920732 | Completed DMC

• 1 other identifier: KLLY-2024-093
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Gynecologic Cancer-related Lower Extremity Lymphedema; Lymphedema

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

Secondary Outcomes (4)

• Cellulitis Infection Rate (episodes/year)

  Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

• Change in Lymphoedema Quality of Life (LYMQOL) Score

  Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)

• Incidence of Surgical Complications

  Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)

• Changes in Lymphoscintigraphy and Ultrasound Findings

  Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months

Study Arms (3)

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.

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.

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.

Procedure: LVA（Lymphaticovenular Anastomosis）; Procedure: LS（Liposuction）

Interventions

VLNT（Vascularized Lymph Node Transfer） PROCEDURE

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.

VLNT + LS (Vascularized Lymph Node Transfer + Liposuction); VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction)

LVA（Lymphaticovenular Anastomosis） PROCEDURE

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.

LVA + LS (Lymphaticovenular Anastomosis + Liposuction); VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction)

LS（Liposuction） PROCEDURE

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.

LVA + LS (Lymphaticovenular Anastomosis + Liposuction); VLNT + LS (Vascularized Lymph Node Transfer + Liposuction); VLNT + LVA + LS (Vascularized Lymph Node Transfer + Lymphaticovenular Anastomosis + Liposuction)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zunyi Medical College: lead

Study Sites (1)

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

Location

Related Publications (1)

• 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.

  PMID: 41602404 DERIVED

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Burn and Plastic Surgery

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CN (1)