Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA

NCT ID: NCT06323200

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 189 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-03-31

Brief Summary

This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching.

Detailed Description

With an increase in the incidence and treatment of breast and gynecological cancers, an increase in the prevalence of secondary lymphedema has been witnessed1. As a consequence of lymphadenectomy and adjuvant radiotherapy, swollen limbs result from the accumulation of protein rich fluid2. Lymphedema is predicted to arise in 20-40% of patients with cervical and breast cancer3, which is a chronic disease that can significantly hamper quality of life4-6. Affected limbs may suffer from lifelong swelling with functional impairment and repeated cellulitis, and some may eventually progress to late-stage diseases such as elephantiasis and lymphorrhea7-9.

Supermicrosurgical lymphaticovenous anastomosis (LVA) is a well-documented minimally invasive treatment modality that bypasses lymph into the venous system to alleviate lymphedema10-14. It was a common belief that a longer lymphedema duration (LD) may be associated with inferior lymphatic vessel (LVs) quality, as well as excess fibrous components in the affected limbs, which are characteristics of advanced lymphedema. Consequently, owing to inferior LV quality, LVA is considered unsuitable for advanced cases; instead, vascularized lymph node transfer (VLNT) or excisional procedures are recommended7,15.

However, growing evidence has demonstrated the effectiveness of LVA for the treatment of severe lymphedema16-19. These findings, contrary to common beliefs, raise questions regarding the association between LD, LV quality, and outcomes after LVA. This study aimed to address the impact of LD on the quality of LV as well as the outcome after LVA using propensity score matching.

Conditions

Lymphedema

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Lymphedema duration > 3.6 years

lymphaticovenous anastomosis

Intervention Type: PROCEDURE

The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).

Lymphedema duration ≤ 3.6 years

lymphaticovenous anastomosis

Intervention Type: PROCEDURE

The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).

Interventions

lymphaticovenous anastomosis

The patients were under intravenous general anesthesia with local anesthetic infiltration for each incision21. LVs were detected by intradermal injection of ICG into the web spaces between the toes and on the medial and lateral malleoli. ICG flow with linear dermal backflow(DB) patterns was detected immediately using a handheld near-infrared camera. The recipient veins were marked using B-mode echo Doppler, close to the marked linear pattern. In case of DB pattern, the incision was made along the great saphenous vein. A 3 cm incision was made and the lymphatics and recipient veins were identified. All patients underwent supermicrosurgical LVA with 11- 0 nylon sutures using a high-power surgical microscope by a single senior surgeon. LVAs are performed using only antegrade flow lymphatics and lymphaticovenous end-to-end anastomosis (LVEEA) and end-to-side anastomosis (LVESA).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.

Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria

• Primary lymphedema, bilateral lower limb lymphedema, history of previous LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure, and those that were lost to follow-up.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202400221B0

Identifier Type: -

Identifier Source: org_study_id