lymphedema
Conditions
Interventions
As a preoperative test for lymphaticovenular anastomosis (LVA), MR lymphangiography (MRL) is performed using gadobutrol as a contrast agent to measure the location of the contrast reach point and the
Sponsors
Yasunaga Yoshichika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with a diagnosis of secondary lymphedema of the lower or upper extremities who are scheduled for surgery. (2) The planned procedure is lymphaticovenular anastomosis (LVA). (3) International Society of Lymphology (ISL) stage II (early stage II, late stage II) (4) Patients whose written consent has been obtained prior to enrollment (5) Age: 20 years or older (6) Performance Status (PS) Score: 0 or 1 according to Eastern Cooperative Oncology Group (ECOG) criteria
Exclusion criteria
Exclusion criteria: (1) Patients with contraindications to MRI imaging (non-MRI-compatible metals, body metals not confirmed as 3T MRI-compatible in the product document, claustrophobia) (2) History of allergy to gadolinium-based contrastagent (3) Patients undergoing treatment for bronchial asthma (4) Patients with renal dysfunction (eGFR < 30mL/min/1.73m2) (5) Others: Patients who, in the judgment of the physician, are considered to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of adverse events with gadobutrol MRL (pain during subcutaneous injection of gadobutrol,anaphylactic reaction for 7 days after the test, and skin disorder for 7 days after the test) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Height of the contrast reach point of gadobutrol MRL (2) Depth of gadbutrol MRL-detected lymphatic vessels anastomosed in LVA surgery (3) Thickness of gadbutrol MRL-detected lymphatic vessels anastomosed in LVA surgery (4) Water volume reduction in the affected limb at1 year postoperatively (5) Edema reduction rate at 1 year postoperatively(unilateral cases only) (6) Number of cellulitis incidents in the affected limb during the first year postoperatively | — |
Contacts
Public ContactJun Araki
Shizuoka Cancer Center
Outcome results
None listed