Management of Symptomatic Post-operative Lymphocele

April 3, 2019 updated by: Maciej Stukan, MD, PhD

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a symptomatic lymphocele after retroperitoneal, abdominal, pelvic lymphadenectomy for treatment or staging procedures for cancer management.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maciej Stukan, Gdynia Oncology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Lymphocele

Clinical Trials on Drainage and sclerotherapy.

3
Subscribe