OncologyProspective Randomized Controlled Trial Exploring the Effect of TachoSil on Lymphocele Formation After Extended Pelvic Lymph Node Dissection in Prostate Cancer
Section snippets
Trial Design and Patients
Between 2013 and 2016, patients with prostate cancer undergoing a PLND at Ghent University Hospital were offered to sign an informed consent to be included in this phase 4 randomized controlled trial with parallel design (ClinicalTrials.gov, NCT02001857). The patients were randomized 1:1 for bilateral TachoSil placement using a random number generator (producing consecutive numbers 0-9, as much as required) and completed block allocation. The patients were stratified according to the type of
Patient and Tumor Characteristics
Between October 17, 2013, and September 2, 2016, we enrolled 100 patients with prostate cancer who were set to undergo staging PLND before external beam radiotherapy (n = 50) or PLND concomitant with RP (n = 50) (Supplementary Fig. S2). As presented in Table 1, no significant differences were observed in patient and tumor characteristics between the TachoSil and the control groups, neither for patients undergoing sole PLND nor for patients undergoing PLND with RP.
Patients undergoing sole PLND
Comment
This prospectively randomized study was set up to explore whether TachoSil reduces the development of lymphoceles after PLND in patients with prostate cancer. Lymphatic vessels have no muscular layer as opposed to blood vessels. Transection of a blood vessel will lead to vasoconstriction and eventual stopping of the bleeding thanks to this muscular layer. This is not the case with lymphatic vessels, and transection will lead to prolonged lymphorrhea. Therefore, the most effective way to prevent
Conclusion
Patients undergoing bilateral TachoSil placement after PLND seem less likely to develop a radiographic lymphocele early postoperatively. However, no difference was seen in lymphocele volume, symptomatic lymphocele rate, lymphorrhea, overall complications, or length of hospital stay. Therefore, the clinical relevance of the use of TachoSil as a lymphostatic agent remains highly debatable.
References (21)
- et al.
Pelvic lymph node dissection in prostate cancer
Eur Urol
(2009) - et al.
Impact of extent of lymphadenectomy on survival after radical prostatectomy for prostate cancer
Urology
(2006) - et al.
More extensive pelvic lymph node dissection improves survival in patients with node-positive prostate cancer
Eur Urol
(2015) - et al.
Predictors of symptomatic lymphocele after lymph node excision and radical prostatectomy
Urology
(2010) - et al.
The use of a surgical patch in the prevention of lymphoceles after extraperitoneal pelvic lymphadenectomy for prostate cancer: a randomized prospective pilot study
J Urol
(2009) - et al.
Evaluation of absorbable hemostatic powder for prevention of lymphoceles following robotic prostatectomy with lymphadenectomy
Urology
(2016) - et al.
Radiotherapy in prostate cancer patients with pelvic lymphocele after surgery: clinical and dosimetric data of 30 patients
Clin Genitourin Cancer
(2015) - et al.
Efficacy and safety of tachosil ® as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study
Eur Urol
(2007) - et al.
Extended pelvic lymphadenectomy in patients undergoing radical prostatectomy: high incidence of lymph node metastasis
J Urol
(2002) - et al.
Sclerotherapy in the management of postoperative lymphocele
J Vasc Interv Radiol
(2010)
Cited by (0)
Financial Disclosure: The authors declare that they have no relevant financial interests.
Funding Support: This work was supported by the Clinical Research Fund from the Ghent University Hospital. Furthermore, this study was sponsored by Takeda by providing the required TachoSil sponges.