Management of Symptomatic Post-operative Lymphocele

NCT02800980 | Unknown

• 1 other identifier: GCO-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphocele

Keywords

lymphocele; sclerotherapy; drainage; percutaneous

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (3)

• Number of successful catheter insertion into lymphocele lumen.

  1 day

• Number of adverse events concerned with catheter insertion.

  2 months

• Number of adverse events concerned with sclerotherapy.

  2 months

Other Outcomes (1)

• Patient's experience on the treatment.

  2 months.

Study Arms (2)

Drainage and sclerotherapy.

Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.

Procedure: Drainage and sclerotherapy.

Drainage alone.

Patients with symptomatic lymphocele who are managed with percutaneous drainage alone.

Procedure: Drainage alone.

Interventions

Drainage and sclerotherapy. PROCEDURE

Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.

Drainage and sclerotherapy.

Drainage alone. PROCEDURE

Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).

Drainage alone.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maciej Stukan, MD, PhD: lead

Study Sites (1)

Gdynia Oncology Center

Gdynia, 81-519, Poland

RECRUITING

Related Publications (3)

• Stukan M, Dudziak M. Lymphocele in gynecologic oncology practice - management and prophylaxis. Nowotwory Journal of Oncology 61 (3): 272-278, 2011.

  BACKGROUND

• 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.

  PMID: 20537556 RESULT

• 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.

  PMID: 25434633 RESULT

Related Links

• A video step-by-step procedure of vascular catheter insertion into lymphocele lumen followed by sclerotherapy.

MeSH Terms

Conditions

Lymphocele

Interventions

Drainage; Sclerotherapy

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative; Drug Therapy

Study Officials

• Maciej Stukan

  Gdynia Oncology Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Stukan

CONTACT

+48692112481; maciej.stukan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)