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- Stranne, Johan, 1970, et al.
(författare)
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SPCG-15 : a prospective randomized study comparing primary radical prostatectomy and primary radiotherapy plus androgen deprivation therapy for locally advanced prostate cancer
- 2018
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Ingår i: Scandinavian journal of urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 52:5-6, s. 313-320
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To describe study design and procedures for a prospective randomized trial investigating whether radical prostatectomy (RP) ± radiation improves cause-specific survival in comparison with primary radiation treatment (RT) and androgen deprivation treatment (ADT) in patients with locally advanced prostate cancer (LAPC).Materials and methods: SPCG-15 is a prospective, multi-centre, open randomized phase III trial. Patients are randomized to either standard (RT + ADT) or experimental (RP with extended pelvic lymph-node dissection and with addition of adjuvant or salvage RT and/or ADT if deemed necessary) treatment. Each centre follows guidelines regarding the timing and dosing of postoperative RT and adjuvant treatment such as ADT The primary endpoint is cause-specific survival. Secondary endpoints include metastasis-free and overall survival, quality-of-life, functional outcomes and health-services requirements. Each subject will be followed up for a minimum of 10 years.Results: Twenty-three centres in Denmark, Finland, Norway and Sweden, well established in performing RP and RT for prostate cancer participated. Each country’s sites were coordinated by national coordinating investigators and sub-investigators for urology and oncology. Almost 400 men have been randomized of the stipulated 1200, with an increasing rate of accrual.Conclusions: The SPCG-15 trial aims to compare the two curatively intended techniques supplying new knowledge to support future decisions in treatment strategies for patients with LAPC The Scandinavian healthcare context is well suited for performing multi-centre long-term prospective randomized clinical trials. Similar care protocols and a history of entirely tax-funded healthcare facilitate joint trials.
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- Törnqvist, B, et al.
(författare)
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Original articleSelective intraoperative cholangiography and risk of bile ductinjury during cholecystectomy
- 2015
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Ingår i: British Journal of Surgery. - : Oxford University Press (OUP). - 0007-1323 .- 1365-2168. ; 102:8, s. 952-958
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Whether intraoperative cholangiography can prevent iatrogenic bile duct injury during cholecystectomy remains controversial.METHODS: Data from the national Swedish Registry for Gallstone Surgery, GallRiks (May 2005 to December 2010), were analysed for evidence of iatrogenic bile duct injury during cholecystectomy. Patient- and procedure-related risk factors for bile duct injury with a focus on the rate of intended intraoperative cholangiography were analysed using multivariable logistic regression.RESULTS: A total of 51 041 cholecystectomies and 747 bile duct injuries (1·5 per cent) were identified; 9008 patients (17·6 per cent) were diagnosed with acute cholecystitis. No preventive effect of intraoperative cholangiography was seen in uncomplicated gallstone disease (odds ratio (OR) 0·97, 95 per cent c.i. 0·74 to 1·25). Operating in the presence (OR 1·23, 1·03 to 1·47) or a history (OR 1·34, 1·10 to 1·64) of acute cholecystitis, and open surgery (OR 1·56, 1·26 to 1·94), were identified as significant risk factors for bile duct injury. The intention to perform intraoperative cholangiography was associated with a reduced risk of bile duct injury in patients with concurrent (OR 0·44, 0·30 to 0·63) or a history of (OR 0·59, 0·35 to 1·00) acute cholecystitis.CONCLUSION: Any proposed protective effect of intraoperative cholangiography was restricted to patients with (or a history of) acute cholecystitis.
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