Multicenter Randomized Clinical Trial for Comparison of the Efficacy between Lymph Node Embolization using Glue and Ethanol Sclerotherapy in the Management of Symptomatic Postoperative Pelvic Lymphocele

Seoul National University Hospital0 个研究点目标入组 88 人开始时间: 待定最近更新: 2020年8月18日

试验速览

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•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

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