Comparison Study between Lymph Node Embolization and Sclerotherapy for Postoperative Pelvic Lymphocele
- Conditions
- Injury, poisoning and certain other consequences of external causes
- Registration Number
- KCT0003078
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 88
A. Patients with postoperative lymphoceles accounting for symptoms which requires medical intervention, of which cause-effect relation is proved by resolution of the symptoms after the decompression of the lymphoceles by percutaneous catheter drainage.
B. Symptoms requiring medical intervention (1 or more of the following lists)
i. Leg edema, discomfort, pain, skin change caused by extrinsic compression of draining vein by the mass effect of lymphocele
ii. Hydronephrosis caused by extrinsic compression of ureter by the mass effect of lymphocele
iii. Other symptoms (abdominal fullness, discomport, pain, lower urinary tract symptoms) caused by the mass effect of lymphocele
iv. Lymphatic leakage from the fistula between the lymphocele and skin/wound
v. Repeated infection (more than twice) of persisting lymphocele
A.Patients with lymphoceles but without symptoms that are related to their presence
B.Patients with less than 20mL of initial daily drainage amount
C.No improvement of symptoms after percutaneous catheter drainage of lymphocele
D.Absolute contraindication to Lipiodol
E.Patients who cannot undergo sclerotherapy due to hypersensitivity to sclerosant (in this case, ethyl alcohol 99%)
F.Chylous ascites (ascites that is grossly white/turbid or that which contains triglyceride higher than 110 mg/dL)
G.Urinary leak (demonstrated on urography or fluid containing high level creatinine)
H.Exudative fluid collections resulting from malignancies (determined by radiologic imaging or fluid analysis)
I.Lymphocele communicating with peritoneum to manifest as ascites
J.Lymphocele communicating with skin or wound severely, to which Ethanol sclerotherapy cannot be applied
K.Uncontrolled infection of lymphocele (If the infection is controlled within 5 days after percutaneous draiange and antibiotics treatment, the lymphocele can be included)
L.Lymphocele invaded by residual or recurrent malignancy
M.Severe lymphedema (International Society of Lymphology stage 2 or 3)
N.Minors (age under 19 years) and other vulnerable subjects
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary clinical success rate
- Secondary Outcome Measures
Name Time Method Primary treatment period;Secondary clinical success rate;Secondary treatment period;Recurrence rate of symptomatic lymphocele;Reduction rate of the diameter of the lymphocele