Kidney CancerEfficacy and Safety of TachoSil® as Haemostatic Treatment versus Standard Suturing in Kidney Tumour Resection: A Randomised Prospective Study☆
Introduction
Over recent years, nephron-sparing surgery (NSS) has become the standard treatment for small (<4 cm), peripherally located kidney tumours in patients with a normal contralateral kidney [1], [2], [3], [4]. The benefits of NSS include decreased risk of renal insufficiency [5] and positive impact on quality of life [6], [7]. It is likely that partial nephrectomy will become increasingly common [8]. In addition, recent publications recommend nephron-sparing surgery even in selected patients with localised RCC > 4 cm with an optimal long-term outcome [9], [10], [11], [12].
However, despite the move towards less extensive surgery and the availability of numerous treatment modalities, intra- and postoperative haemorrhage of the kidney resection surface remains a challenge. The current standard haemostatic method is suturing, although actual techniques may vary slightly between centres.
TachoSil is a sterile ready-to-use absorbable patch for intraoperative topical application. It consists of an equine collagen patch coated with the fibrin glue components, human fibrinogen and human thrombin. It thus combines the assets of a pliable patch material with the haemostatic and adhesive properties of the coagulation factors. The product is currently approved in Europe for supportive haemostatic treatment in surgery. The efficacy and safety of Tachosil have been demonstrated in liver resection [12], [14] and pulmonary lobectomy [15], [16] trials. The predecessors of TachoSil (TachoComb® and TachoComb® H) have proven to be efficacious haemostats and tissue sealants from several years of clinical use.
This study evaluated TachoSil as a haemostatic adjunct treatment in NSS and compared the haemostatic efficacy and safety of TachoSil with standard suturing.
Section snippets
Study design and objectives
This was an open, randomised, prospective, multicentre and multinational, parallel group phase 3 trial. Resection of small, superficial kidney tumours not extending into the collecting duct system were performed by open surgery by using standard techniques. However, use of laser scalpel, infrared coagulator, or argon beamer was not allowed for the resection, and the integrity of the pelvicalyceal system was to be maintained. Primary control of major haemorrhagic points was performed by using
Results
A total of 208 patients were screened, with 185 being included in the trial at 13 centres in Austria, Belgium, and Germany between September 2002 and October 2004. The ITT population consisted of patients randomly allocated to TachoSil (n = 92) and standard suturing (n = 93). A total of 3 patients discontinued from the trial (TachoSil: 1 patient because of nephrectomy and 1 because of patient noncompliance; standard suturing: 1 patient because of nephrectomy; Fig. 1). One TachoSil patch was used in
Discussion
The present trial demonstrates that TachoSil provides a useful adjunctive treatment option to primary haemostasis in NSS. Earlier studies have demonstrated that long-term cancer-free survival after NSS is comparable to that of radical nephrectomy, especially in low-stage renal carcinoma with localised, cortical tumours with a diameter ≤4 cm and with a normal contralateral kidney (elective indication) [1], [2], [3], [5], [17], [18], [19], [20] provided a sufficiently large margin of resection [18]
Conflicts of interest
The study was sponsored by Nycomed Denmark and the Department of Urology of the University of the Saarland was reimbursed financially for all expenses made.
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