Prostate or Bladder CancerPhase 4NCT02001857
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
A Phase 4 study testing 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery. in people with Prostate or Bladder Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prostate or Bladder Cancer
- What is being tested?
- 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Aug 2017
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Diagnosis of prostate cancer or bladder cancer on pathology
- Undergoing transperitoneal pelvic lymph node dissection.
Who cannot join
- Previous pelvic surgery or irradiation.
- Any type of clotting disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue sealing. They could reduce lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer surgery.
- Conditions
- Prostate or Bladder Cancer
- Being tested
- 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.
- Keywords
- patients,, undergoing, pelvic, lymph, node, dissection.
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.Drug
at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| TachoSil | Experimental | TachoSil Receives: Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery. |
| No TachoSil | No intervention | No TachoSil |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of a radiographic lymphocele on abdominal ultrasonography
Measured: at week 1 post-surgery
volume of radiographic lymphoceles
Measured: at week 1 post-surgery
duration of postoperative drainage catheter
Measured: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
volume produced by postoperative drainage catheter (lymphorrhea)
Measured: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
specific for bladder cancer
Measured: Daily during standard postoperative care up to date of first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation), with an expected average of 1 day.
development of a radiographic lymphocele on abdominal ultrasonography
Measured: at week 4 post-surgery
volume of radiographic lymphoceles
Measured: at week 4 post-surgery
Secondary outcomes (8)
development of a symptomatic lymphocele.
Measured: at week 1 post-surgery
decrease in serum hemoglobin on the first postoperative day
Measured: at week 1 post-surgery
duration of hospital stay
Measured: at week 1 post-surgery
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Measured: at week 1 post-surgery
development of a symptomatic lymphocele.
Measured: at week 4 post-surgery
decrease in serum hemoglobin on the first postoperative day
Measured: at week 4 post-surgery
duration of hospital stay
Measured: at week 4 post-surgery
total cost
Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.
Measured: at week 4 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate or Bladder CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Nicolaas Lumen, MD, PhD, FEBU, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001857
- Sponsor's protocol ID
- EC/2013/472
- Other IDs
- 2013-000782-36
- Status last verified
- Aug 2017
- First submitted
- 28 Oct 2013
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.
- ClinicalTrials.gov ID
- NCT02001857
- Acronym / sponsor ID
- EC/2013/472
- Conditions
- Prostate or Bladder Cancer
- Keywords
- patients,, undergoing, pelvic, lymph, node, dissection.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Sep 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 Dec 2013 (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.
Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue sealing. They could reduce lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TachoSil | Experimental | Drug: 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.TachoSil |
| No TachoSil | No intervention | –No TachoSil |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old
- Diagnosis of prostate cancer or bladder cancer on pathology
- Undergoing transperitoneal pelvic lymph node dissection.
Key exclusion criteria (2 listed)
- Previous pelvic surgery or irradiation.
- Any type of clotting disorder.
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 |
|---|---|---|
| 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.at the end of surgery | Drug | TachoSil |
Primary outcome
development of a radiographic lymphocele on abdominal ultrasonography
Time frame: at week 1 post-surgery
volume of radiographic lymphoceles
Time frame: at week 1 post-surgery
duration of postoperative drainage catheter
Time frame: Daily during standard postoperative care until removal of the catheter, with an expected average of 1 day.
volume produced by postoperative drainage catheter (lymphorrhea)
Time frame: Daily during standard postoperative care until removal of the drain, with an expected average of 1 day.
time between operation and first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation).
Time frame: Daily during standard postoperative care up to date of first flatus, first peristalsis, first passing of stool and removal of gastrostomy tube (signs of ileus recuperation), with an expected average of 1 day.
specific for bladder cancer
development of a radiographic lymphocele on abdominal ultrasonography
Time frame: at week 4 post-surgery
volume of radiographic lymphoceles
Time frame: at week 4 post-surgery
8 secondary outcomes
development of a symptomatic lymphocele.
Time frame: at week 1 post-surgery
decrease in serum hemoglobin on the first postoperative day
Time frame: at week 1 post-surgery
duration of hospital stay
Time frame: at week 1 post-surgery
total cost
Time frame: at week 1 post-surgery
development of a symptomatic lymphocele.
Time frame: at week 4 post-surgery
decrease in serum hemoglobin on the first postoperative day
Time frame: at week 4 post-surgery
duration of hospital stay
Time frame: at week 4 post-surgery
total cost
Time frame: at week 4 post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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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.
Nicolaas Lumen, MD, PhD, FEBU principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery. in people with Prostate or Bladder Cancer, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 25 Aug 2017. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of a radiographic lymphocele on abdominal ultrasonography (time frame: at week 1 post-surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.