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Supplemental material, sj-docx-1-sjs-10.1177_14574969231181228 for Practice patterns in diagnostics, staging, and management strategies of gallbladder cancer among Nordic tertiary centers by Sini Takala, Kristoffer Lassen, Kjetil Søreide, Ernesto Sparrelid, Jon-Helge Angelsen, Erling A. Bringeland, Malin S. Eilard, Oskar Hemmingsson, Bengt Isaksson, Heikki Karjula, Jukka-Pekka Lammi, Peter N. Larsen, Maija Lavonius, Gert Lindell, Frank V. Mortensen, Kim Mortensen, Arno Nordin, Torsten Pless, Per Sandström, Oddvar Sandvik, Yrjö Vaalavuo, Christina Villard and Ville Sallinen in Scandinavian Journal of Surgery

Background Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of choice although almost half of the resected patients get recurrence in the liver. Methods The ASAC trial is a Scandinavian, multicentre, double-blinded, randomized, placebo-controlled study to determine whether adjuvant treatment with low-dose aspirin (acetylsalicylic acid (ASA)) can improve disease-free survival in patients treated for colorectal cancer liver metastases (CRCLM). Up to 800 patients operated for CRCLM will be randomized to Arm#1 ASA 160 mg once daily or Arm#2 Placebo, for a period of 3 years or until disease recurrence. The patients will be recruited at all major hepatobiliary surgical units in Norway, Sweden and Denmark and have follow-up according to standard of care and the National Guidelines. Discussion The ASAC trial will be the first clinical interventional trial to assess the potential beneficial role of ASA in recurrence of CRCLM and survival. ASA is an inexpensive, well-tolerated and easily accessible drug that will be highly potential as adjuvant drug in secondary prevention of CRCLM if the study shows a beneficial effect. We will also determine the effect of ASA as adjuvant treatment on Health-Related Quality of Life and the cost-effectiveness. Trial registration ClinicalTrials.gov NCT03326791. Registered on 31 October 2017.

Introduction: Occurrence of liver metastases is common following colorectal cancer (CRC), and resection is the only option with a potential for cure offered to a minor part of these patients. During the last decades there have been major improvements in the oncosurgical treatment, along with expansions in inclusion criteria for surgery. The majority of the patients will unfortunately experience post-resection recurrence. Divergent results have been presented regarding the need of clear resection margins (RMs) to accomplish an optimal outcome. Data on national resection rates in patients with CLM are sparse. Aim of the thesis: I: To study RMs and the correlation with local recurrence (LR) pattern, time to recurrence (TTR) and overall survival (OS) in patients resected for CLM. II: To study patterns of recurrence, and post-recurrence survival (PRS) according to sites of recurrence following resection for CLM. III: To study resection rates in patients diagnosed with CLM in Norway, focusing on characteristics like age, geographical regions and primary tumour. Methods: Paper I and II are based on a combined retrospective (1998-2008) and prospective (2009-2012) retrieved database of consecutive patients treated with resection for CLM at Haukeland University Hospital. Paper III is based on synchronized data from the Norwegian Patient Registry (NPR) and the Cancer Registry of Norway (CRN) where patients with a diagnosis of CRC (ICD-10: C18-20) and liver metastases (C78.7) were enrolled (2011-2013). Cumulative resection rates (CRR) following CLM were retrieved from any registration of hepatic resection (NCSP: JJB) in the data set. TTR, OS and CRR (paper I-III) were obtained using Kaplan Meier method with Log-rank test (univariate) and COX regression analysis (multivariate). All the studies were accepted by the Regional Committee for Medical and Health Research Ethics (REKVest). Results: A total of 242, 311 and 2960 patients were enrolled in paper I, II and III, respectively. In paper I the patients were grouped according to the width of the resection margins

We determined prognostic impact of KRAS, BRAF, PIK3CA and TP53 mutation status and mutation heterogeneity among 164 colorectal cancer (CRC) patients undergoing liver resections for metastatic disease. Mutation status was determined by Sanger sequencing of a total of 422 metastatic deposits. In univariate analysis, KRAS (33.5%), BRAF (6.1%) and PIK3CA (13.4%) mutations each predicted reduced median time to relapse (TTR) (7 vs. 22, 3 vs. 16 and 4 vs. 17 months; p, What's new? Preliminary evidence suggests that poor outcome after liver resection in metastatic colorectal cancer (CRC) is predicted by mutations in KRAS and BRAF and by intra‐individual heterogeneity involving copy number alterations that vary from one metastatic lesion to the next. Little is known, however, about the clinical implications of intra‐individual mutation heterogeneity in CRC. Here, in a comparison of KRAS and BRAF wild‐type status, mutational homogeneity, and mutational heterogeneity, mutation heterogeneity was found to be the strongest predict or of reduced disease‐specific survival following liver resection in metastatic CRC. Knowledge of intra‐individual mutation heterogeneity in KRAS and BRAF in CRC could facilitate therapeutic decisions.

Background: Despite progress in resection for colorectal liver metastases (CLM), the majority of patients experience recurrence. We aimed to evaluate factors influencing time to recurrence (TTR), treatment and post-recurrence survival (PRS) related to site of recurrence. Methods: This is a retrospective population-based cohort study (1998–2012) of consecutive patients without extrahepatic disease treated with resection for CLM in a referral centre. Results: A total of 311 patients underwent resection for CLM. After a median follow-up of 4.2 years (range 1.2–15.2), 209 (67.4 %) patients developed recurrence, hepatic 90, extrahepatic 59 and both 60. Median TTR was 14.0 months, and 5-year recurrence-free status was 25.7 %. Five- and 10-year overall survival (OS) was 38.8 and 22.0 %, respectively. Median OS was 45 months. A multivariate analysis displayed synchronous disease (hazard ratio (HR) 1.50), American Society of Anaesthesiologists (ASA) score (HR 1.40), increasing number (HR 1.24) and size of metastases (HR 1.08) to shorten TTR (all p

Background: The purpose of this study was to evaluate the clinical course and possible benefit of a percutaneous cholecystostomy in patients with acute cholecystitis. Methods: Retrospective study of 104 patients with severe cholecystitis or cholecystitis not responding to antibiotic therapy treated with percutaneous drainage of the gall bladder (PC) during the period 2007 – 2013. Primary outcome was relief of cholecystitis, complications following the procedure and need for later cholecystectomy. Results: There were 57 men and 47 women with a median age of 73,5 years (range 22 – 96). 43% of the patients were ASA III or IV and 91% had cholecystitis Grade 2 or 3. About 60% of the patients had severe comorbidity (cardiovascular disease or active cancer). Drain insertion was successful in all but one patient and complications were mild, apart from two patients that needed percutaneous drainage of intraabdominal fluid collection due to bile leakage. The drain was left in place for 1 – 75 days (median 6,5). When evaluated clinically and by blood tests (CRP and white blood cell counts) we found resolution of symptoms in 101 patients (97,2%), whereas 2 patients had no obvious effect of drainage. Four patients died within 30 days, no deaths were related to the drainage procedure. Follow-up after drainage was median 12 months (range 0 – 78). During that time cholecystectomy was performed in 30 patients and 24 patients had died. Following cholecystectomy, two had died, both from cancer and more than one year after the operation. Conclusion: Patients with acute cholecystitis were promptly relieved from their symptoms following PC. There were only minor complications following the procedure and only about 30% of the patients had a later cholecystectomy. publishedVersion