Elsevier

Urology

Volume 118, August 2018, Pages 134-140
Urology

Oncology
Prospective Randomized Controlled Trial Exploring the Effect of TachoSil on Lymphocele Formation After Extended Pelvic Lymph Node Dissection in Prostate Cancer

https://doi.org/10.1016/j.urology.2018.05.008Get rights and content

Objective

To explore whether TachoSil, a hemostatic patch, can reduce the incidence of lymphocele formation. Development of a lymphocele is a frequent complication after pelvic lymph node dissection (PLND) for nodal staging in prostate cancer.

Materials and Methods

From 2013 to 2017, 100 patients with prostate cancer who were set to undergo a staging PLND before external beam radiotherapy (n = 50) or PLND concomitant with radical prostatectomy (RP) (n = 50) were prospectively randomized 1:1 between bilateral TachoSil placement or nonplacement. Primary end points were radiographic lymphocele development, lymphocele volume (1 week and 1 month postoperatively), and the duration and volume of postoperative catheter drainage.

Results

Patient, tumor, and surgical characteristics of the TachoSil and the control groups did not differ significantly. In total, 65 patients (65%) experienced a radiographic lymphocele up to 3 months after surgery: 29 (58%) in the TachoSil group and 36 (72%) in the control group (P = .34). Significantly less radiographic lymphoceles were observed 1 week postoperatively for patients who underwent sole PLND and 1 month postoperatively for patients who underwent PLND with RP in the TachoSil group compared with the control group (16% vs 48%, P = .024, and 24% vs 52%, P = .047, respectively). The other postoperative characteristics presented no significant differences between the 2 groups, neither for patients undergoing sole PLND nor for patients undergoing PLND with RP.

Conclusion

Patients undergoing bilateral TachoSil placement after PLND seem less likely to develop a radiographic lymphocele early postoperatively. Nevertheless, the clinical relevance of the use of TachoSil remains highly debatable.

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.

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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.

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