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Management of Symptomatic Post-operative Lymphocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800980
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Maciej Stukan, MD, PhD, Gdynia Oncology Center

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.


Condition or disease Intervention/treatment
Lymphocele Procedure: Drainage and sclerotherapy. Procedure: Drainage alone.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study
Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Group/Cohort Intervention/treatment
Drainage and sclerotherapy.
Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.
Procedure: 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.
Procedure: Drainage alone.
Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of successful catheter insertion into lymphocele lumen. [ Time Frame: 1 day ]
  2. Number of adverse events concerned with catheter insertion. [ Time Frame: 2 months ]
  3. Number of adverse events concerned with sclerotherapy. [ Time Frame: 2 months ]

Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a symptomatic lymphocele after retroperitoneal, abdominal, pelvic lymphadenectomy for treatment or staging procedures for cancer management.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800980


Contacts
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Contact: Maciej Stukan +48692112481 maciej.stukan@gmail.com

Locations
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Poland
Gdynia Oncology Center Recruiting
Gdynia, Poland, 81-519
Contact: Maciej Stukan, MD    +48692112481    mstukan@szpital-morski.pl   
Contact    +48587260508    maciej.stukan@gmail.com   
Sponsors and Collaborators
Maciej Stukan, MD, PhD
Investigators
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Principal Investigator: Maciej Stukan Gdynia Oncology Center
Additional Information:
Publications of Results:
Other Publications:
Stukan M, Dudziak M. Lymphocele in gynecologic oncology practice - management and prophylaxis. Nowotwory Journal of Oncology 61 (3): 272-278, 2011.

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Responsible Party: Maciej Stukan, MD, PhD, Dr, Gdynia Oncology Center
ClinicalTrials.gov Identifier: NCT02800980    
Other Study ID Numbers: GCO-3
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maciej Stukan, MD, PhD, Gdynia Oncology Center:
lymphocele
sclerotherapy
drainage
percutaneous
Additional relevant MeSH terms:
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Lymphocele
Cysts
Neoplasms
Lymphatic Diseases