Efficacy of a Fibrin Sealant for the Prevention of Lymphocele After Lymphadenectomy

NCT03914963 | Completed Phase 3 FDA Drug

• 1 other identifier: ONC-1111
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: Lymphocele (LC) is a potential complication of lymph node removal. The objective of this study was to assess the efficacy of the Tissucol Duo® (Baxter AG Industriestrasse 67 A-1221 Vienna, Austria) fibrin sealant in decreasing the incidence of LC after pelvic laparoscopic lymph node dissection using harmonic shears. Material and Methods: This prospective double blind randomised study was conducted between February 2012 and June 2016 in Donostia University Hospital (Spain). Overall, 74 patients diagnosed with gynaecological cancer gave written informed consent and were included in the study. After bilateral pelvic lymphadenectomy, the fibrin sealant was used following manufacturer's instructions in one hemipelvis but not the other. Overall, the product was applied in 41 (55.4%) left and 33 (44.6%) right hemipelvises. The primary objective of the study was to determine the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography and magnetic resonance) was performed to detect LC at 3, 6 and 12 months after surgery.

Conditions

Lymphocele

Keywords

Fibrin Tissue Adhesive; Lymph node dissection

Outcome Measures

Primary Outcomes (1)

• assess the efficacy of the Tissucol Duo® (Baxter AG Industriestrasse 67 A-1221 Vienna, Austria) fibrin sealant in decreasing the incidence of LC after pelvic laparoscopic lymph node dissection using harmonic shears

  Tissucol Duo®, marketed under the name of Tisseel® Fibrin Sealant in some countries, is a physiological haemostatic sealant containing fibrinogen and thrombin with haemostatic, sealant, adhesive and healing properties. It can be employed in laparoscopic surgery using a spray system that that spreads the product across the wound surface and, in theory, can help to seal lymph vessels and thereby reduce the incidence of lymphadenectomy and associated complications. The objective of this prospective study was to assess the efficacy of Tissucol Duo® sealant in decreasing the incidence of LC after laparoscopic pelvic lymphadenectomy using harmonic shears

  12 months

Study Arms (2)

Fibrin sealant treatment hemipelvis

EXPERIMENTAL

•Drug: Following the manufacturer´s instructions, 5 ml of sealant was sprayed evenly across the entire surgical bed in only one hemipelvis (the treated hemipelvis).

Biological: Fibrin sealant hemipelvis

Control hemipelvis

PLACEBO COMPARATOR

Other hemipelvis

Biological: Control hemipelvis

Interventions

Fibrin sealant hemipelvis BIOLOGICAL

Following the manufacturer´s instructions, 5 ml of sealant was sprayed evenly across the entire surgical bed in only one hemipelvis (the treated hemipelvis) after pelvis bilateral lymphadenectomy.

Fibrin sealant treatment hemipelvis

Control hemipelvis BIOLOGICAL

Contralateral hemipelvis not treated with fibrin sealant

Control hemipelvis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had endometrial, cervical, or ovarian cancer, underwent PL, an expected survival of more than 12 weeks and appropriate bone marrow, kidney and liver function, as well as that they agreed to participate and signed the informed consent form

You may not qualify if:

• Patients were excluded if they had previously received radiotherapy or chemotherapy, haematological disorders including coagulation defects, a history of thromboembolic disease or lymphatic system disorders (lymphedema or lymphocele), or allergy to aprotinin, as well as if they declined to participate or did not sign the informed consent form.

Sponsors & Collaborators

• IBON JAUNARENA: lead

MeSH Terms

Conditions

Lymphocele

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• IBON JAUNARENA, Consultant

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient, doctors who performed the follow-up and initially the surgeon were blinded to the randomization sequence and site of application. That is, the surgeon was only told to which hemipelvis the sealant was to be applied when he considered that the surgical procedure had been completed.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecologist Oncologist

Model Details: After standard preoperative assessment, patients were randomly assigned to having Tissucol Duo® applied to the surgical bed in only the right or only the left hemipelvis after bilateral pelvic lymphadenectomy. Following the manufacturer´s instructions, 5 ml of sealant was sprayed evenly across the entire surgical bed in only one hemipelvis (the treated hemipelvis). We decided to treat only one hemipelvis in each patient, thereby allowing patients to serve as their own controls, in order to compare outcomes with and without the sealant in the same body with the same clinical characteristics and reduce the influence of other factors beyond the treatment.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: April 16, 2019
• Study Start: February 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 16, 2019

Record last verified: 2019-04