Clinical trial NCT02800980: Management of Symptomatic Post-operative Lymphocele
Official title: Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphocele
Keywords: lymphocele
sclerotherapy
drainage
percutaneous
Lead sponsor: Gdynia Oncology Center
Sponsor class: OTHER_GOV
First posted: 2016-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a symptomatic lymphocele after retroperitoneal, abdominal, pelvic lymphadenectomy for treatment or staging procedures for cancer management.

Brief summary: Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. Management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat LC, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic LC is diagnosed.

The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic LC - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.

Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated volume of LC and other organs failure if appear is recorded. Management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. After vascular catheter insertion into LC and fluid evacuation, patient is followed with active drainage. Patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. In case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice.

Data concerning feasibility, safety and efficacy are noted in designated templates. Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.

The study is observational. Primary outcome measure is to establish efficacy of the method. Secondary outcome measures are safety and patient's experience on the treatment.

Investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.


Eligibility criteria: Inclusion Criteria:

* symptomatic lymphocele after abdominal lymphadenectomy for cancer,
* age \> 18 years old,
* informed consent signed,

Exclusion Criteria:

* asymptomatic lymphocele,
* apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion),
* significant coagulopathy

Primary outcomes:
measure: Number of patients with successful lymphocele treatment.
timeFrame: 2 months
Secondary outcomes:
measure: Number of successful catheter insertion into lymphocele lumen.
timeFrame: 1 day
measure: Number of adverse events concerned with catheter insertion.
timeFrame: 2 months
measure: Number of adverse events concerned with sclerotherapy.
timeFrame: 2 months
Other outcomes:
measure: Patient's experience on the treatment.
timeFrame: 2 months.
Locations:
city: Gdynia
country: Poland
facility: Gdynia Oncology Center
Study officials:
affiliation: Gdynia Oncology Center
name: Maciej Stukan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stukan M, Dudziak M. Lymphocele in gynecologic oncology practice - management and prophylaxis. Nowotwory Journal of Oncology 61 (3): 272-278, 2011.
citation: Mahrer A, Ramchandani P, Trerotola SO, Shlansky-Goldberg RD, Itkin M. Sclerotherapy in the management of postoperative lymphocele. J Vasc Interv Radiol. 2010 Jul;21(7):1050-3. doi: 10.1016/j.jvir.2010.03.014. Epub 2010 Jun 2.
citation: Stukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M. Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecol Oncol. 2015 Mar;136(3):466-71. doi: 10.1016/j.ygyno.2014.11.073. Epub 2014 Nov 28.