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Comparison Study between Lymph Node Embolization and Sclerotherapy for Postoperative Pelvic Lymphocele

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003078
Enrollment
88
Registered
2018-08-07
Start date
2018-08-21
Completion date
Unknown
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Both groups: The lymphocele will be targeted under ultrasound guidance and a drainage catheter will be placed in the lymphocele cavity under fluoroscopy. Thereafter, the patients w
of the initial amount of fluid that was evacuated from the cavity. Maximum treatemnt period for each group is up to 10 days. Sclerotherapy group: 99&#37
ethyl alcohol is used as a sclerosant. The amount of sclerosant is dependent on the size of the lymphocele cavity, where 50&#37
of the daily drainage volume recorded on the last day is administered into the cavity. The maximum amount should not exceed 100 mL to prevent risk of alcohol intoxication. Five minutes after administe

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Primary clinical success rate

Secondary

MeasureTime frame
Primary treatment period;Secondary clinical success rate;Secondary treatment period;Recurrence rate of symptomatic lymphocele;Reduction rate of the diameter of the lymphocele

Countries

Korea, Republic of

Contacts

Public ContactSaebeom Hur

Seoul National University Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026