LymphoceleNCT02800980
Management of Symptomatic Post-operative Lymphocele
An observational study of Lymphocele, run by Maciej Stukan, MD, PhD at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocele
- What is being tested?
- Drainage and sclerotherapy. and Drainage alone.
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2016to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a symptomatic lymphocele after retroperitoneal, abdominal, pelvic lymphadenectomy for treatment or staging procedures for cancer management.
Who may be able to join
- symptomatic lymphocele after abdominal lymphadenectomy for cancer,
- age > 18 years old,
- informed consent signed,
Who cannot join
- asymptomatic lymphocele,
- apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion),
- significant coagulopathy
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Gdynia Oncology Center
Gdynia, 81-519
Maciej Stukan, MD, +48692112481, mstukan@szpital-morski.pl
+48587260508, maciej.stukan@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Lymphocele
- Being tested
- Drainage and sclerotherapy., Drainage alone.
- Keywords
- lymphocele, sclerotherapy, drainage, percutaneous
- Medical subject headings
- Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage and sclerotherapy.Procedure or surgery
Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.
Drainage alone.Procedure or surgery
Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Drainage and sclerotherapy. | Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy. Receives: Procedure: Drainage and sclerotherapy. | |
| Drainage alone. | Patients with symptomatic lymphocele who are managed with percutaneous drainage alone. Receives: Procedure: Drainage alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful lymphocele treatment.
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.
Measured: 2 months
Secondary outcomes (3)
Number of successful catheter insertion into lymphocele lumen.
Measured: 1 day
Number of adverse events concerned with catheter insertion.
Measured: 2 months
Number of adverse events concerned with sclerotherapy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maciej Stukan, MD, PhD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Maciej Stukan, MD, PhD, Gdynia Oncology Center
- Investigators
- Maciej Stukan, Principal investigator, Gdynia Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800980
- Sponsor's protocol ID
- GCO-3
- Status last verified
- Apr 2019
- First submitted
- 7 Jun 2016
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 20537556Stukan 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.
PubMed 25434633
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study
- ClinicalTrials.gov ID
- NCT02800980
- Acronym / sponsor ID
- GCO-3
- Conditions
- Lymphocele
- Keywords
- lymphocele, sclerotherapy, drainage, percutaneous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maciej Stukan, MD, PhDOther government
- Study start
- Jun 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drainage and sclerotherapy. | – | Procedure: Drainage and sclerotherapy.Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy. |
| Drainage alone. | – | Procedure: Drainage alone.Patients with symptomatic lymphocele who are managed with percutaneous drainage alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a symptomatic lymphocele after retroperitoneal, abdominal, pelvic lymphadenectomy for treatment or staging procedures for cancer management.
Key inclusion criteria (3 listed)
- symptomatic lymphocele after abdominal lymphadenectomy for cancer,
- age > 18 years old,
- informed consent signed,
Key exclusion criteria (3 listed)
- asymptomatic lymphocele,
- apparent infection of the skin or subcutaneus tissue over the lymphocele (in the place of potential catheter insertion),
- significant coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drainage and sclerotherapy.Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy. | Procedure or surgery | Drainage and sclerotherapy. |
| Drainage alone.Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy). | Procedure or surgery | Drainage alone. |
Primary outcome
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.
3 secondary outcomes
Number of successful catheter insertion into lymphocele lumen.
Time frame: 1 day
Number of adverse events concerned with catheter insertion.
Time frame: 2 months
Number of adverse events concerned with sclerotherapy.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- BackgroundStukan M, Dudziak M. Lymphocele in gynecologic oncology practice - management and prophylaxis. Nowotwory Journal of Oncology 61 (3): 272-278, 2011.
- Results publication: PubMed 20537556Mahrer 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.
- Results publication: PubMed 25434633Stukan 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.
- A video step-by-step procedure of vascular catheter insertion into lymphocele lumen followed by sclerotherapy.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lymphocele
Recruiting
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Lymphocele
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Stukan principal investigator
Gdynia Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphocele, run by Maciej Stukan, MD, PhD at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maciej Stukan (+48692112481, maciej.stukan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful lymphocele treatment. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800980, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.