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Background This study was designed to evaluate the safety, efficiency, effectiveness, and overall long-term outcome in patients treated with microwave thermal ablation of hepatic tumors. Microwave ablation technology represents the next generation in ablative techniques for the treatment of hepatic malignancies. Currently there have been no large reports of its use in the United States with appropriate long-term follow-up. Methods An institutional review board-approved prospective phase II study of microwave ablation of hepatic malignancies from January 2004 to January 2009 was performed. All complications were recorded up to 90 days from operation and reported using an established five-point grading scale. Results One hundred patients underwent 270 ablations for hepatic malignancies. The most tumor types were as follows: metastatic colorectal cancer (50%), hepatocellular carcinoma (17%), metastatic carcinoid (11%), and other metastatic disease (22%). A majority of patents (53%) underwent combination hepatic resection and microwave ablation; 38% underwent ablation alone, 9% underwent ablation and additional organ resection, with 68% open procedures. Median tumor size was 3.0 (range, 0.6–6.0) cm, median number of tumors was 2 (range, 1–18), and median total ablation time was 13 (range, 5–45) min. Overall 90-day mortality was 0% and morbidity was 29%. One patient developed a hepatic abscess and no patients experienced bleeding complications. After a median follow-up of 36 months, 5 patients (5%) had incomplete ablation, 2 (2%) had local recurrence at the ablated site, and 37 (37%) developed intrahepatic recurrence at nonablated sites. Conclusions Microwave ablation of hepatic tumors is a safe and effective method for treating unresectable hepatic tumors, with a low rate of local recurrence.

BackgroundEarly recurrence following liver resection for metastatic colorectal cancer generally portends poor survival. We sought to identify factors associated with early disease recurrence after major hepatectomy for metastatic colorectal cancer in order to improve patient selection and prevent futile hepatectomy.MethodsSequential major (four or more segments) liver resections performed for metastatic colorectal cancer between 1995 and 2019 were selected from our prospectively maintained database. Univariate analyses, multivariable regression modelling, and survival analyses were used to identify predictors of futile resection (recurrence within 6 months of hepatectomy).ResultsOf 259 patients included, the median age was 61.3 years (interquartile range [IQR] 15.3) and the median number of liver tumors was 3.0 (IQR 2.0); 78.0% of patients received prehepatectomy chemotherapy. Surgeries were right (56.4%), left (19.3%), and extended hepatectomy (24.3%). Futile resection occurred in 26 (12.6%) patients. Margin positivity was similar in the futile resection group compared with the non-futile resection group (11.5% vs. 11.4%). Extrahepatic disease that disappeared with chemotherapy was present in 23.1% of patients with a futile resection and 7.2% of those without (p = 0.019). After multivariable regression, the factors predictive of futile resection were extrahepatic disease (odds ratio [OR] 5.6; p = 0.004), more than three liver lesions (OR 4.9; p = 0.001), and extended hepatectomy (OR 2.6; p = 0.038). Notably, 70.8% of futile recurrences occurred within the liver remnant and 20.8% were pulmonary metastases. Overall survival was 11.7 months (95% confidence interval [CI] 7.1–16.2) for the futile resection cohort versus 45.6 (95% CI 39.1–52.1) for non-futile hepatectomies (p < 0.001).ConclusionsFutile hepatic resection can be predicted based on preoperative factors and carries a poor prognosis. Improved risk stratification for futility will aid in patient selection and treatment discussions.

BackgroundUnresectable intrahepatic cholangiocarcinoma (ICC) carries a poor prognosis, and currently there are moderately established chemotherapeutic [gemcitabine/cisplatin (Gem/Cis)] treatments to prolong survival. The purpose of this study was to assess the efficacy of irinotecan drug-eluting beads (DEBIRI) therapy by transarterial infusion in combination with systemic therapy in unresectable ICC.Patients and MethodsThis is a prospective, multicenter, open-label, randomized phase II study (Clin Trials: NCT01648023-DELTIC trial) of patients with ICC randomly assigned to Gem/Cis with DEBIRI or Gem/Cis alone. The primary endpoint was response rate.ResultsThe intention-to-treat population comprised 48 patients: 24 treated with Gem/Cis and DEBIRI and 22 with Gem/Cis alone (2 screen failures). The two groups were similar with respect to the extent of liver involvement (35% versus 38%) and presence of extrahepatic disease (29% versus 14%, p = 0.12). Median numbers of chemotherapy cycles were similar (6 versus 6), as were rates of grade 3/4 adverse events (34% for the Gem/Cis-DEBIRI group versus 36% for the Gem/Cis group). The overall response rate was significantly greater in the Gem/Cis-DEBIRI arm versus the Gem/Cis arm at 2 (p < 0.04), 4 (p < 0.03), and 6 months (p < 0.05). There was significantly more downsizing to resection/ablation in the Gem/Cis-DEBIRI arm versus the Gem/Cis arm (25% versus 8%, p < 005), and there was improved median progression-free survival [31.9 (95% CI 8.5–75.3) months versus 10.1 (95% CI 5.3–13.5) months, p = 0.028] and improved overall survival [33.7 (95% CI 13.5–54.5) months versus 12.6 (95% CI 8.7–33.4) months, p = 0.048].ConclusionCombination Gem/Cis with DEBIRI is safe, and leads to significant improvement in downsizing to resection, improved progression-free survival, and overall survival.

Purpose This international, multicenter, single-arm trial assessed efficacy and safety of intralesional rose bengal (PV-10) in 80 patients with refractory cutaneous or subcutaneous metastatic melanoma. Methods Sixty-two stage III and 18 stage IV melanoma patients with disease refractory to a median of six prior interventions received intralesional PV-10 into up to 20 cutaneous and subcutaneous lesions up to four times over a 16-week period and were followed for 52 weeks. Objectives were to determine best overall response rate in injected target lesions and uninjected bystander lesions, assess durability of response, and characterize adverse events. Results For target lesions, the best overall response rate was 51 %, and the complete response rate was 26 %. Median time to response was 1.9 months, and median duration of response was 4.0 months, with 8 % of patients having no evidence of disease after 52 weeks. Response was dependent on untreated disease burden, with complete response achieved in 50 % of patients receiving PV-10 to all of their disease. Response of target lesions correlated with bystander lesion regression and the occurrence of locoregional blistering. Adverse events were predominantly mild to moderate and locoregional to the treatment site, with no treatment-associated grade 4 or 5 adverse events. Conclusions Intralesional PV-10 yielded durable local control with high rates of complete response. Toxicity was confined predominantly to the injection site. Cutaneous bystander tumor regression is consistent with an immunologic response secondary to ablation. This intralesional approach for local disease control could be complementary to current and investigational treatments for melanoma.

Purpose The aim of this prospective trial was to assess the compliance of a prehabilitation protocol on post-operative outcome after major abdominal and head and neck surgery. Methods A single-arm, prospective 7-day intervention trial was approved by our local IRB for patients undergoing major abdominal and head-and-neck (H&N) surgery from 8/2018 to 3/2019. This was a 7-day intervention trial at the time of pre-admission testing to assess compliance for pulmonary, nutritional, and physical activity prior to surgery. Results Seventy-six patients were enrolled in this compliance with IS use that was 85%, with a median of 2200 cc (range 1500–2500cc), pre-operative nutritional drink (89.5%), and chlorhexidine gluconate use was 92%. Ambulation/step compliance was only 32 patients (44%), with median steps of 7500 (range 400–15,000). Compared with the non-prehabilitation patients, we found significant improvement in immediate post-operative mobility (OR 0.73, 95% CI 0.46–0.97, p = 0.04), and improvement in prevention of pulmonary morbidity (OR 0.82, 95% CI 0.23–1.18, p = 0.07) was observed in the prehabilitation group. No significant difference in overall infectious complications (18% vs 27%), surgical site infections (14% vs 22%), length of stay (median 6 days vs 6), or readmissions (18% vs 22%). Conclusions A simple 7-day prehabilitation protocol at the time of pre-admission testing is feasible with a high degree of compliance regardless of a patient’s disease type, education, or socioeconomic background.

The University of Louisville has observed a near 70% drop in resectable/borderline resectable metastatic colorectal cancer in the past 5 years. The aim of this study was to evaluate the distribution of colon cancer metastasis at diagnosis and at recurrence. Stage was defined by the American joint committee on cancer (AJCC) eighth edition. Institutional review board approval was granted for post hoc review of stage II and III patients with colon cancer from the University of Louisville prospective hepatic database from 2002 to 2023, as well as for the National cancer database (NCDB) Participant user file (PUF) 2021. The Surveillance epidemiology and end-results (SEER) 22 database was also utilized to corroborate the findings in the NCDB. Between 2018 and 2021 pathological M1a decreased annually (51.9-46.3%), while M1c increased year-over-year (26.6-32.4%) and M1b stayed relatively the same (21.4-21.3%). These differences were significant on chi-squared analysis with a p value of < 0.001. Univariate analysis of the post hoc review between 2017 and 2020 revealed significant differences between stage 4a and 4c in terms of race (p value 0.018), carcinoembryonic antigen (CEA) at diagnosis (p value 0.037), CEA at recurrence (p value 0.012), presence of liver metastasis (p value 0.003), and referral pattern (p value 0.014). Multivariate analysis identified stage 4b as an independent predictor for hepatic metastasis (odds ratio; OR 4.69, p value 0.011). A significant change in the distribution of colon cancer metastases has occurred at an institutional and national level over the past 3-5 years. Interdisciplinary treatment strategies will have to be modified accordingly.

Background Exocrine pancreatic insufficiency (EPI) occurs when pancreatic enzyme activity in the intestinal lumen is insufficient for normal digestion to occur. The true incidence and diagnosis of EPI after pancreatectomy has not been fully understood and optimized. The aim of this study was to present incidence and diagnostic criteria for EPI after pancreatectomy for cancer and provide a guide for management and optimal therapy in pancreatectomy patients with cancer. Methods A comprehensive review of the literature with publication dates from 2014 to 2019 was performed. A comprehensive diagnostic and treatment algorithm was then created based on literature review and current treatment options. Results In total, 30 studies were included, 19 combined both pancreaticoduodenectomy (PD) and distal pancreatectomy (DP), 9 for central pancreatectomy, and 2 others. EPI was defined subjectively without definitive testing using any of the established diagnostic studies in the majority of studies 23 (76%). Preoperative EPI was calculated to be 11.52%. Most studies assessed exocrine function at least 6 months postoperatively with four studies extending the follow-up period beyond 12 months. EPI diagnosed postoperatively at 1 month (40.27%), 3 months (30.94%), 6 months (36.06%), and 12 months (34.69%). After PD, the median prevalence of postoperative EPI was 43.14%, CP, the median prevalence was 4.85%, DP, median prevalence of postoperative EPI of 11.94%. Conclusion EPI is a frequent outcome that is often misdiagnosed or under-reported by the patient post-pancreatectomy. Given the increasing overall survival in pancreatectomy patients for cancer, surgeon awareness and assessment is critical to improving patients’ overall quality of life.