- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800980
Management of Symptomatic Post-operative Lymphocele
Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maciej Stukan
- Phone Number: +48692112481
- Email: maciej.stukan@gmail.com
Study Locations
-
-
-
Gdynia, Poland, 81-519
- Recruiting
- Gdynia Oncology Center
-
Contact:
- Maciej Stukan, MD
- Phone Number: +48692112481
- Email: mstukan@szpital-morski.pl
-
Contact:
- Phone Number: +48587260508
- Email: maciej.stukan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Drainage and sclerotherapy.
Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.
|
Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.
|
Drainage alone.
Patients with symptomatic lymphocele who are managed with percutaneous drainage alone.
|
Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with successful lymphocele treatment.
Time Frame: 2 months
|
Successful lymphocele treatment means complete resolution of lymphocele after minimally invasive procedures - percutaneous drainage with a vascular catheter followed by sclerotherapy or drainage alone.
Opposite - non successful treatment defined when the patient is refered for a surgical management.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of successful catheter insertion into lymphocele lumen.
Time Frame: 1 day
|
1 day
|
Number of adverse events concerned with catheter insertion.
Time Frame: 2 months
|
2 months
|
Number of adverse events concerned with sclerotherapy.
Time Frame: 2 months
|
2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's experience on the treatment.
Time Frame: 2 months.
|
measured with a questionnaire FACIT-TS-G (Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General) available from http://www.facit.org/facitorg/questionnaires.
Permission to use obtained.
|
2 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maciej Stukan, Gdynia Oncology Center
Publications and helpful links
General Publications
- Stukan M, Dudziak M. Lymphocele in gynecologic oncology practice - management and prophylaxis. Nowotwory Journal of Oncology 61 (3): 272-278, 2011.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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