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Liver-directed hepatic arterial therapies are associated with improved survival and effective symptom control for patients with unresectable neuroendocrine liver metastases (NELM). Whether transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) with yttrium-90 (y-90) are associated with improved short- or long-term outcomes is unknown.A retrospective review was performed of all patients with NELM undergoing transarterial therapies, from 2000 to 2018, at 2 academic medical centers. Postoperative morbidity, radiographic response according to response evaluation criteria in solid tumors (RECIST) criteria, and long-term outcomes were compared between patients who underwent TACE vs TARE.Among 248 patients with NELM, 197 (79%) received TACE and 51 (21%) received TARE. While patients who underwent TACE were more likely to have carcinoid syndrome, larger tumors, and higher chromogranin A levels, there was no difference in tumor differentiation, primary site, bilobar disease, or synchronous presentation. Nearly all TARE treatments (92%) were performed as outpatient procedures, while 99% of TACE patients spent at least 1 night in the hospital. There were no differences in overall morbidity (TARE 13.7% vs TACE 22.6%, p = 0.17), grade III/IV complication (5.9% vs 9.2%, p = 0.58), or 90-day mortality. The disease control rate (DCR) on first post-treatment imaging (RECIST partial/complete response or stable disease) was greater for TACE compared with TARE (96% vs 83%, p0.01). However, there was no difference in median overall survival (OS, 35.9 months vs 50.1 months, p = 0.3) or progression-free survival (PFS, 15.9 months vs 19.9 months, p = 0.37).In this retrospective multi-institutional analysis, both TACE and TARE with Y-90 were safe and effective liver-directed therapies for unresectable NELM. Although TARE was associated with a shorter length of hospital stay, TACE demonstrated improved short-term DCR, and both resulted in comparable long term outcomes.

Background In the 8th edition of the American Joint Committee on Cancer melanoma staging system, the T1b category has been redefined based solely on thickness and ulceration. National Comprehensive Cancer Network guidelines recommend consideration of sentinel lymph node biopsy (SLNB) for all patients with T1b melanomas (0.8 to 1.0 mm thick). We hypothesized that the new staging system would lead to excessive use of SLNB in patients with non-ulcerated T1b melanomas with a low risk of positive sentinel lymph nodes. Study Design The National Cancer Database 2015 Melanoma Public Use File was used to select patients undergoing SLNB for thin T1 cutaneous melanoma from 2010 to 2015. Clinicopathologic risk factors for having a positive SLNB were evaluated. Univariable and multivariable logistic regression models and classification and regression tree analysis were performed to identify groups with high and low risk of positive SLNB. Results We selected patients undergoing SLNB without ulceration with thickness 0.75 to 1.04 mm, staged T1b in the new 8th edition American Joint Committee on Cancer by thickness criteria alone (6,894 patients). Independent risk factors for a positive sentinel lymph node were age 56 years or younger (odds ratio [OR] 1.74; 95% CI 1.38 to 2.17), thickness 1.0 vs 0.8 to 0.9 mm (OR 1.36; 95% CI 1.09 to 1.70), female sex (OR 1.36; 95% CI 1.09 to 1.69), and mitotic rate ≥1/mm2 (OR 2.01; 95% CI 1.54 to 2.64). Classification and regression tree analysis identified 2 groups based on age, mitotic rate, and thickness with a risk of positive SLNB Conclusions The new 8th edition American Joint Committee on Cancer melanoma staging system T1b category should not be used to determine use of SLNB in thin melanoma, as more than one half of T1b lesions without ulceration have a low risk of positive sentinel lymph nodes.

This study sought to evaluate re-excision rates, patient satisfaction with their breasts, and healthcare costs before and after publication of 2014 Society of Surgical Oncology/American Society of Radiation Oncology consensus guideline on margins for breast conserving operation with whole-breast irradiation for stage I and II breast cancer at an academic institution.Patients with stage I and II invasive carcinomas who underwent partial mastectomy were divided into 2 groups based on whether they were treated before (PRE) or after (POST) guideline publication in March 2014. Groups were compared with respect to re-excision rates, conversion to mastectomy, specimen volumes, mean cost per patient of surgical care, and prospectively collected patient post-procedure quality of life.A total of 237 patients who underwent partial mastectomy were examined (n = 126 in the PRE group and n = 111 in the POST group). Patients in the POST group were less likely to require re-excision (9% POST vs 37% PRE; p0.001) and were less likely to undergo conversion to mastectomy (5% POST vs 14% PRE; p = 0.02). After consensus guideline publication, mean operative cost per patient decreased ($4,874 POST vs $5,772 PRE; p0.001), and patients had improved breast quality of life scores (77 out of 100 POST vs 61 out of 100 PRE; p = 0.03). On multivariable analysis, publication of the consensus statement was an independent predictor of decreased re-excision rates (odds ratio 0.17; 95% CI 0.08 to 0.38; p0.001) and operative cost per patient (odds ratio 0.14; 95% CI 0.78 to 0.30; p0.001).Widespread implementation of the consensus guideline on margins for breast conserving operation will likely lead to the intended improvements in operative and financial outcomes, as well as patient satisfaction with breast conserving operation.

The value of routine primary (intraoperative) drain placement after major hepatectomy remains unclear. We sought to determine if primary drainage led to decreased rates of complications, specifically, intra-abdominal biloma or infection requiring a secondary (postoperative) drainage procedure.All patients who underwent major hepatectomy (≥3 hepatic segments) at 3 institutions, from 2000 to 2012, were identified. Patients with biliary anastomoses were excluded. Primary outcomes were any complication, rate of secondary drainage procedures, bile leak, and 30-day readmission.There were 1,041 patients who underwent major hepatectomy without biliary anastomosis; 564 (54%) had primary drains placed at the surgeon's discretion. Primary drain placement was associated with increased complications (56% vs 44%; p0.001), bile leaks (7.3% vs 4.2%; p = 0.048), and 30-day readmissions (16.4% vs 8.0%; p0.001), but was not associated with a decrease in secondary drainage procedures (8.0% vs 5.9%; p = 0.23). Patients with primary drains demonstrated higher American Society of Anesthesioloigsts (ASA) class, greater blood loss, more transfusions, and larger resections. After accounting for these significant clinicopathologic variables on multivariate analysis, primary drain placement was not associated with increased risk of any complications. Primary drainage was, however, independently associated with increased risk of bile leak (hazard ratio [HR] 2.04; 95% CI1.02 to 4.09; p = 0.044) and 30-day readmission (HR 1.79; 95% CI1.14 to 2.80; p = 0.011). There still was no reduction in the need for secondary drainage procedures (HR 0.98; p = 0.96).Primary intraoperative drain placement after major hepatectomy does not decrease the need for secondary drainage procedures and may be associated with increased bile leaks and 30-day readmissions. Routine drain placement is not warranted.

Background Hospital readmission is becoming a quality measure, despite poor understanding of the risks of readmission. This study examines readmission risk factors after major hepatectomy and develops a predictive model. Study Design A retrospective review was performed on patients who had undergone major hepatectomy at 1 of 3 academic centers between the years 2000 and 2012. Clinicopathologic and perioperative data were analyzed for risk factors of 90-day readmission using logistic regression. A readmission risk score was developed and validated in a separate validation set to determine its predictive value. Results Of 1,184 hepatectomies performed, 17.3% of patients were readmitted within 90 days. Factors associated with readmission include operative blood loss (odds ratio [OR] = 1.00; 95% CI, 1.000–1.001), any postoperative complication (OR = 4.3; 95% CI, 1.8–10.4), a major postoperative complication (OR = 5.7; 95% CI, 3.2–10.2), postoperative pulmonary embolism (OR = 12.2; 95% CI, 1.9–78.4), no postoperative blood transfusion (OR = 3.3; 95% CI, 1.7–6.2), surgical site infection (OR = 5.3; 95% CI, 2.9–10.0), and post-hepatectomy hyperbilirubinemia (OR = 1.1; 95% CI, 1.1–1.2). A scoring system based on these risk factors accurately predicted readmission in the validation cohort. A score of >20 points had a positive predictive value of 30.8% and negative predictive value of 95.6%, and a score >50 had a positive predictive value of 50.9% and negative predictive value of 87.7%. This risk score accurately stratifies readmission risk. Conclusions The risk of hospital readmission within 90 days after major hepatectomy is high and is reliably predicted with a novel scoring system.

Background Renal insufficiency adversely affects outcomes after cardiac and vascular surgery. The effect of preoperative renal insufficiency on outcomes after major hepatectomy is unknown. Study Design All patients who underwent major hepatectomy (≥3 segments) at 3 institutions from 2000 to 2012 were identified. Resections were performed using low central venous pressure anesthesia. Renal function was analyzed by preoperative serum creatinine (sCr) level. Primary outcomes were major complications (Clavien grade III to V), respiratory failure, renal failure requiring hemodialysis, and 90-day mortality. Results One thousand one hundred and seventy patients had preoperative sCr levels available. Renal function was analyzed using sCr dichotomized at 1.8 mg/dL, 1 SD higher than the mean value (0.97 ± 0.79 mg/dL) for the cohort. Twenty-two patients had sCr ≥1.8 mg/dL. Major complications occurred in 279 patients (23.8%), respiratory failure in 62 (5.3%), and renal failure in 31 (2.6%). Ninety-day mortality rate was 5.4%. On multivariate analysis, patients with sCr ≥1.8 mg/dL remained at significantly increased risk for major complications (hazard ratio = 3.94; 95% CI, 1.48–10.49; p = 0.006), respiratory failure (hazard ratio = 4.43; 95% CI, 1.33–14.80; p = 0.014), and renal failure (hazard ratio = 4.75; 95% CI, 1.19–18.97; p = 0.028). Serum Cr ≥1.8 mg/dL was not independently associated with 90-day mortality on multivariate analysis (p = 0.27). Conclusions Preoperative serum creatinine ≥1.8 mg/dL identifies patients at significantly increased risk of postoperative major complications, respiratory failure, and renal failure requiring dialysis. Patients are well selected for major hepatectomy, and few patients with substantial renal insufficiency are deemed operative candidates.

Background Multiple methods have been proposed to classify the micrometastatic tumor burden in sentinel lymph nodes (SLN) for melanoma. The purpose of this study was to determine the classification scheme that best predicts nonsentinel node (NSN) metastasis, disease-free survival (DFS), and overall survival (OS). Study Design A single reviewer reanalyzed tumor-positive SLN from a multicenter, prospective clinical trial of patients with melanoma ≥1.0 mm Breslow thickness who underwent SLN biopsy. The following micrometastatic disease burden measurements were recorded: Starz classification, Dewar classification (microanatomic location), maximum diameter of the largest focus of metastasis, maximum tumor area, and sum of all diameters. Univariate and multivariate models and Kaplan-Meier analysis were used to evaluate each classification system. Results We reviewed 204 tumor-positive SLNs from 157 patients. On univariate analysis, all criteria except Starz classification were statistically significant risk factors for NSN metastasis. On multivariate analysis, including Breslow thickness, ulceration, age, sex, and NSN status, maximum diameter (using a cut-off of 3 mm) was the only classification system that was an independent risk factor predicting DFS (hazard ratio 2.31, p = 0.0181) and OS (hazard ratio 3.53, p = 0.0005). By Kaplan-Meier analysis, DFS and OS were significantly different among groups using maximum diameter cut-offs of 1 and 3 mm. Conclusions Maximum tumor diameter outperformed other measurements of metastatic tumor burden, including microanatomic tumor location (Dewar classification), Starz classification, maximum tumor area, and sum of all diameters for prediction of survival. Maximum tumor diameter is a simple method of assessing micrometastatic tumor burden that should be reported routinely.

Distal cholangiocarcinoma (DC) and pancreatic ductal adenocarcinoma (PDAC) are often managed as 1 entity, yet direct comparisons are lacking. Our aim was to use 2 large multi-institutional databases to assess treatment, pathologic, and survival differences between these diseases.This study included patients with DC and PDAC who underwent curative-intent pancreaticoduodenectomy from 2000 to 2015 at 13 institutions comprising the US Extrahepatic Biliary Malignancy and Central Pancreas Consortiums. Primary endpoint was disease-specific survival (DSS).Of 1,463 patients, 224 (15%) had DC and 1,239 (85%) had PDAC. Compared with PDAC, DC patients were less likely to be margin-positive (19% vs 25%; p = 0.005), lymph node (LN)-positive (55% vs 69%; p0.001), and receive adjuvant therapy (57% vs 71%; p 0.001). Of DC patients treated with adjuvant therapy, 62% got gemcitabine alone and 16% got gemcitabine/cisplatin. Distal cholangiocarcinoma was associated with improved median DSS (40 months) compared with PDAC (22 months; p0.001), which persisted on multivariable analysis (hazard ratio 0.65; 95% CI 0.50 to 0.84; p = 0.001). Lymph node involvement was the only factor independently associated with decreased DSS for both DC and PDAC. The DC/LN-positive patients had similar DSS as PDAC/LN-negative patients (p = 0.74). Adjuvant therapy (chemotherapy ± radiation) was associated with improved median DSS for PDAC/LN-positive patients (21 vs 13 months; p = 0.001), but not for DC patients (38 vs 40 months; p = 0.62), regardless of LN status.Distal cholangiocarcinoma and pancreatic ductal adenocarcinoma are distinct entities. Distal cholangiocarcinoma has a favorable prognosis compared with PDAC, yet current adjuvant therapy regimens are only associated with improved survival in PDAC, not DC. Therefore, treatment paradigms used for PDAC should not be extrapolated to DC, despite similar operative approaches, and novel therapies for DC should be explored.

Background We found that a computer model developed by the American Joint Committee on Cancer (AJCC) melanoma staging committee had limitations for predicting prognosis of patients staged by sentinel lymph node (SLN) biopsy. We sought to develop a model that more accurately predicts prognosis in this population. Study Design Using a data set obtained from a prospective multi-institutional study of 2,507 patients with clinically node-negative melanomas ≥1.0 mm Breslow thickness, we developed a prognostic model using a Cox regression formula incorporating a number of significant clinicopathologic factors. The AJCC model and our model were used to predict 5-year survival from this test data set. The concordance correlation coefficient (CCC) was determined and chi-square tests were performed. Our new prognostic model was validated using an independent data set of 1,001 patients. Results Using the test data set, the CCC for the AJCC model was 0.875; chi-square tests demonstrated statistically significant differences between observed and predicted survivals for numerous clinicopathologic factors. The CCC for our model was 0.976 and none of the chi-square tests was statistically significant. Our model performed similarly well in SLN-negative patients (CCC 0.929) and SLN-positive patients (CCC 0.889). The AJCC model performed well in SLN-negative patients (CCC 0.854), but not in SLN-positive patients (CCC 0.626). Using the validation data set, similar findings were obtained. Conclusions Our prognostic model provides superior survival estimates compared with the AJCC model for patients undergoing SLN biopsy. This online tool is available at www.melanomacalculator.com, and will provide important information that can be used to guide adjuvant therapy decisions and stratification in clinical trials.

Background Low platelet count is a marker of portal hypertension but is not routinely included in the standard preoperative evaluation of patients with hepatocellular carcinoma (HCC) because it pertains to liver function (Child/model for end-stage liver disease [MELD] score) and tumor burden (Milan criteria). We hypothesized that low platelet count would be independently associated with increased perioperative morbidity and mortality after resection. Study Design Patients treated with liver resection for HCC between January 2000 and January 2010 at 3 institutions were eligible. Preoperative platelet count, Child/MELD score, and tumor extent were recorded. Low preoperative platelet count (LPPC) was defined as 3 /μL. Postoperative liver insufficiency (PLI) was defined as peak bilirubin >7 mg/dL or development of ascites. Univariate and multivariate regression was performed for predictors of major complications, PLI, and 60-day mortality. Results A total of 231 patients underwent resection, of whom 196 (85%) were classified as Child A and 35 (15%) as Child B; median MELD score was 8. Overall, 168 (71%) had tumors that exceeded Milan criteria and 134 (58%) had major hepatectomy (≥3 Couinaud segments). Overall and major complication rates were 55% and 17%, respectively. PLI occurred in 25 patients (11%), and 21 (9%) died within 60 days of surgery. Patients with LPPC (n = 50) had a significantly increased number of major complications (28% versus 14%, p=0.031), PLI (30% versus 6%, p=0.001), and 60-day mortality (22% versus 6%, p=0.001). When adjusted for Child/MELD score and tumor burden, LPPC remained independently associated with increased number of major complications (odds ratio [OR] 2.8, 95% confidence intervals [CI] 1.1 to 6.8, p=0.026), PLI (OR 4.0, 95% CI 1.4 to 11.1, p=0.008), and 60-day mortality (OR 4.6, 95% CI 1.5 to 14.6, p=0.009). Conclusions LPPC is independently associated with increased major complications, PLI, and mortality after resection of HCC, even when accounting for standard criteria, such as Child/MELD score and tumor extent, used to select patients for resection. Patients with LPPC may be better served with transplantation or liver-directed therapy.

Background Many surgeons are reluctant to use esophageal stents during neoadjuvant therapy for esophageal cancer because of concerns about nutritional status, stent-related complications, or added difficulties during esophagogastrectomy. We hypothesized that esophageal stenting during neoadjuvant therapy allows for optimal nutritional intake without adversely affecting perioperative outcomes. Study Design This study is a prospective, dual-institution, single-arm, phase II evaluation of esophageal cancer patients undergoing neoadjuvant therapy before resection. All patients had a self-expanding polymer stent placed before neoadjuvant therapy. We monitored dysphagia symptoms, nutritional status, stent-related complications, and perioperative complications during the course of therapy and 90 days postoperatively. Results We enrolled 32 patients with dysphagia and weight loss who were eligible for neoadjuvant therapy. After stent placement, 2 patients had stent migrations requiring replacement. No erosive complications were observed. During the course of neoadjuvant therapy, we noted improvement in dysphagia, mild weight loss, and maintenance of performance status. At a median of 50 days (range 18 to 92 days) after completion of neoadjuvant therapy, 20 patients underwent margin-negative esophagogastrectomy (16 Ivor Lewis, 4 minimally invasive) without problems with stent removal or difficulty in surgical dissection. Twelve patients did not undergo resection due to development of metastases (n = 8) or rapid decline in functional status (n = 4). Major perioperative complications included pulmonary embolism (n = 2), chyle leak (n = 1), and bronchial injury (n = 1). No surgical complications were attributed to stent placement. Conclusions Use of esophageal stents during neoadjuvant therapy is safe and results in resolution of dysphagia, mild weight loss, and maintenance of performance status without an effect on intraoperative dissection, perioperative complications, or delay in resection after neoadjuvant therapy.

Background As compared with open distal pancreatectomy (ODP), laparoscopic distal pancreatectomy (LDP) affords improved perioperative outcomes. The role of LDP for patients with pancreatic ductal adenocarcinoma (PDAC) is not defined. Study Design Records from patients undergoing distal pancreatectomy (DP) for PDAC from 2000 to 2008 from 9 academic medical centers were reviewed. Short-term (node harvest and margin status) and long-term (survival) cancer outcomes were assessed. A 3:1 matched analysis was performed for ODP and LDP cases using age, American Society of Anesthesiologists (ASA) class, and tumor size. Results There were 212 patients who underwent DP for PDAC; 23 (11%) of these were approached laparoscopically. For all 212 patients, 56 (26%) had positive margins. The mean number of nodes (± SD) examined was 12.6 ±8.4 and 114 patients (54%) had at least 1 positive node. Median overall survival was 16 months. In the matched analysis there were no significant differences in positive margin rates, number of nodes examined, number of patients with at least 1 positive node, or overall survival. Logistic regression for all 212 patients demonstrated that advanced age, larger tumors, positive margins, and node positive disease were independently associated with worse survival; however, method of resection (ODP vs. LDP) was not. Hospital stay was 2 days shorter in the matched comparison, which approached significance (LDP, 7.4 days vs. ODP, 9.4 days, p=0.06). Conclusions LDP provides similar short- and long-term oncologic outcomes as compared with OD, with potentially shorter hospital stay. These results suggest that LDP is an acceptable approach for resection of PDAC of the left pancreas in selected patients.

A growing body of evidence supports the use of multigene signature panels (MSPs) in predicting recurrence risk in patients with invasive breast cancer. This study aimed to evaluate trends in MSP use over time and the effect of MSPs on administration of postoperative chemotherapy.The National Cancer Database was queried for all women with invasive breast cancer who underwent resection between 2011 and 2014 and had information about performance of an MSP, hormone receptor status, and receipt of chemotherapy. Multigene signature panel use over time was evaluated, and patterns of use of Oncotype DX (ODX) and MammaPrint (MP) were compared.In a total of 476,128 patients, an MSP was obtained in 153,782 (30.2%). Multigene signature panel use increased over time and was associated with a decreased rate of chemotherapy administration (24.6% MSP vs 37.2% no MSP; p0.001). Oncotype DX remained the most common MSP used throughout the study period. Oncotype DX was used more commonly in stage I disease than MP, and MP was used more commonly in stage II and III disease. MammaPrint was more commonly used in hormone receptor-negative patients, human epidermal growth factor receptor 2-positive patients, and patients with positive lymph nodes. Postoperative chemotherapy was administered to a higher proportion of patients assessed with MP than with ODX (41.3% vs 23.4%, respectively; p0.001).Use of MSPs among patients with breast cancer has increased over time and is associated with a decreased use of adjuvant chemotherapy. Oncotype DX continues to be the most widely used MSP, although MP use has increased over time. Future studies are warranted to determine the optimal use of these MSPs in risk assessment and postoperative decision making.

Background The role of adjuvant chemoradiation therapy (CRT) in pancreatic cancer remains controversial. The primary aim of this study was to determine if CRT improved survival in patients with resected pancreatic cancer in a large, multiinstitutional cohort of patients. Study Design Patients undergoing resection for pancreatic adenocarcinoma from seven academic medical institutions were included. Exclusion criteria included patients with T4 or M1 disease, R2 resection margin, preoperative therapy, chemotherapy alone, or if adjuvant therapy status was unknown. Results There were 747 patients included in the initial evaluation. Primary analysis was performed between patients that had surgery alone (n=374) and those receiving adjuvant CRT (n=299). Median followup time was 12.2 months and 14.5 months for survivors. Median overall survival for patients receiving adjuvant CRT was significantly longer than for those undergoing operation alone (20.0 months versus 14.5 months, p=0.001). On subset and multivariate analysis, adjuvant CRT demonstrated a significant survival advantage only among patients who had lymph node (LN)-positive disease (hazard ratio 0.477, 95% CI 0.357 to 0.638) and not for LN-negative patients (hazard ratio 0.810, 95% CI 0.556 to 1.181). Disease-free survival in patients with LN-negative disease who received adjuvant CRT was significantly worse than in patients who had surgery alone (14.5 months versus 18.6 months, p=0.034). Conclusions This large multiinstitutional study emphasizes the importance of analyzing subsets of patients with pancreas adenocarcinoma who have LN metastasis. Benefit of adjuvant CRT is seen only in patients with LN-positive disease, regardless of resection margin status. CRT in patients with LN-negative disease may contribute to reduced disease-free survival.

Background Colon carcinoid remains an uncommon finding during screening endoscopy or operation, with little known about the longterm prognosis. The reason for this uncertainty is that no staging system exists to appropriately risk stratify or follow these patients for overall survival. We sought to investigate prognostic factors associated with colon carcinoid tumors and create a predictive staging system to accurately estimate prognosis. Study Design A search of the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database identified 15,983 patients with carcinoid tumors, with 2,459 from the colon, from 1973 to 2004. Patients were analyzed to various clinicopathologic factors and a tumor (T1, T2, T3), lymph node (N0, N1), and metastasis (M0, M1) staging system was created according to these parameters. Results Of the 2,459 patients, 1,287 (52%) women and 1,172 (48%) men were identified, with a median age of 63 years (range, 12 to 96 years). Lymph node metastasis was found in 820 (48%), and distant metastatic disease was present in 522 (24%) patients. On multivariate analysis, age, size, depth of invasion, lymph node involvement, distant metastasis, and location were significant. Four stages were created to statistically significant prognostic factors: 13% into stage I, 32% into stage II, 12% into stage III, and 43% into stage IV. Five-year survival rates were 97%, 69%, 21%, and 17% for stages I through IV (p = 0.001). Conclusions The newly developed TNM staging system accurately discriminates prognosis for carcinoid tumors of the colon. Incorporation of this staging system into clinical practice will allow better study of outcomes and development of stage-specific treatment recommendations.

Background Molecular staging of sentinel lymph nodes (SLNs) may identify patients who are node-negative by standard microscopic staging but are at increased risk for regional nodal recurrence; such patients may benefit from completion lymph node dissection (CLND). Study Design In a multicenter, randomized clinical trial, patients with tumor-negative SLNs by standard pathology (hematoxylin and eosin [H and E] serial sections and immunohistochemistry [IHC]) underwent reverse transcriptase polymerase chain reaction (PCR) analysis of SLNs for melanoma-specific mRNA. Microscopically negative/PCR+ patients were randomized to observation, CLND, or CLND with high-dose interferon (HDI). For this post-hoc analysis, clinicopathologic features and survival outcomes, including overall survival (OS) and disease-free survival (DFS), were compared between PCR+ patients who underwent CLND vs observation. Microscopic and molecular node-negative (PCR-) patients were included for comparison. Results A total of 556 patients were PCR+: 180 underwent observation, and 376 underwent CLND. An additional 908 PCR- patients were observed. Median follow-up was 72 months. Disease-free survival (DFS) was significantly better for PCR+ patients who underwent CLND compared with observation (p = 0.0218). No statistically significant differences in OS or distant disease-free survival (DDFS) were seen. Regional lymph node recurrence-free survival (LNRFS) was improved in PCR+ patients with CLND compared to observation (p = 0.0065). The PCR+ patients in the observation group had the worst DFS; those with CLND had similar DFS to that in the PCR- group (p = 0.9044). Conclusions Patients with microscopically negative/PCR+ SLN have an increased risk of nodal recurrence that was mitigated by CLND. Although CLND did not affect OS, these data suggest that molecular detection of melanoma-specific mRNA in the SLN predicts a greater risk of nodal recurrence and deserves further study.

Background Level 1 data demonstrate that adjuvant chemotherapy (ACT) improves survival after surgical resection of pancreatic ductal adenocarcinoma (PDAC), (adjuvant gemcitabine, CONKO-001 study; adjuvant 5-FU, ESPAC3 study). The role of adjuvant chemoradiation therapy (ACRT) remains controversial. What is less clear is whether adjuvant therapy influences patterns of recurrence. The purpose of this study was to perform the first multicenter study analyzing patterns of recurrence after adjuvant therapy for PDAC. Study Design Patients undergoing resection for PDAC from 8 medical centers over a 10-year period were analyzed. Demographics, tumor characteristics, operative treatment, type of adjuvant therapy, recurrence pattern, and survival were reviewed. Using Cox-proportional hazards multivariate (MV) regression, the impact of ACT and ACRT on overall survival (OS), local recurrence (LR), and distant recurrence (DR) was investigated. Results There were 1,130 patients who were divided into those having surgery alone (n = 392), ACT (n = 291), or ACRT (n = 447). Median follow-up was 18 months. Compared with patients undergoing surgery alone, ACT, but not ACRT, demonstrated a significant OS advantage on MV analysis. Patients receiving ACT had significantly fewer recurrences (LR and DR); those receiving ACRT had significantly less LR but not DR. On subset MV analysis, ACT and ACRT resulted in less LR in patients with lymph node (LN) positive and margin negative disease. No improvements in LR, DR, or OS were seen in margin positive patients with either ACT or ACRT. Conclusions This is the first analysis demonstrating differences in recurrence patterns in PDAC patients based on type of adjuvant therapy. Adjuvant chemotherapy provided an OS advantage likely related to its effect on reducing both LR and DR. Adjuvant chemoradiation therapy appears to decrease LR, but not DR, and therefore has less impact on OS. Future investigations and treatment protocols should consider additional ACT rather than ACRT in the treatment of PDAC.

Background Combined major hepatectomy with pancreatectomy (MHP) is a rarely used operation for the treatment of hepatobiliary cancer. Few reports have discussed the utility of this procedure and its indications are poorly defined. The aim of this study was to review our experience with MHP. Study design A review of our prospective hepatobiliary surgical database between January 1994 and July 2000 identified 17 patients who had undergone MHP. Preoperative radiographic and laboratory data, intraoperative findings, hospital outcomes, and longterm followup were obtained. Results A total of 3,579 patients with hepatobiliary malignancy were seen at our institution, of which 1,280 underwent resection and 17 (1.3%) had an MHP. The median age was 58 years (range 24 to 76). Histology was as follows: eight neuroendocrine carcinoma, three sarcoma, two cholangiocarcinoma, one ampullary carcinoma, one gallbladder carcinoma, one gastric carcinoma recurrence, and one benign fibrosis. All 17 patients underwent resection of two or more hepatic segments. Nine patients underwent a distal pancreatectomy and eight underwent a pancreaticoduodenectomy. Median operative time was 6 hours (range 4 to 8) and the median blood loss was 900 mL (range 150 to 2,500). Postoperative complications occurred in eight patients (47%), and there were three perioperative deaths (18%). All three deaths occurred in patients who underwent a pancreaticoduodenectomy combined with a hemi-hepactomy or greater. Eight patients are free of disease with a median followup of 54 months. Six patients have recurred, two of whom have died of disease with a median disease-free interval of 8 months. Conclusions MHP is associated with a high morbidity and mortality and should only be considered in highly selected patients when a significant potential oncologic benefit is possible.

BACKGROUND: In gastric adenocarcinoma, only complete resection (R0) translates into survival benefit. Given the potential for increased morbidity and mortality from multiple organ resection we asked the question as to whether extended (multiple organ) resection was justified for advanced gastric cancer. STUDY DESIGN: From July 1985 to July 2000, 1,283 patients underwent gastric resection for adenocarcinoma at Memorial Sloan-Kettering Cancer Center, and were entered and followed in a prospectively recorded database. Four hundred eighteen patients (33%) underwent primary resection and had one or more organs resected in addition to the stomach. Eight hundred twenty-six patients (64%) underwent gastrectomy alone, with 39 patients (3%) not undergoing gastrectomy. Clinicopathologic, operative, and morbidity data were evaluated in this group. Complications were categorized by severity on a scale from 0 to 5, 0 being no complication to 5 being death. Chi-square analysis and the logistic regression method were used to compare and estimate factors significantly associated with having a complication. RESULTS: Three hundred thirty-seven patients had a single additional organ resected, 63 had two organs, and 18 had three organs. Five hundred eighty complications occurred in 33% of patients (404 of 1,283). The perioperative mortality was 4% (48 patients). Logistic regression identified the number of organs resected, two or greater, to be predictive of complications (RR 2.0), as well as age greater than 70 years old (RR 1.57). When excluding minor complications (values 1 and 2), only the number of organs resected (RR 3.8) was a major factor for severe complications (values 3, 4, and 5). CONCLUSIONS: Resection of two or more adjacent organs in advanced gastric adenocarcinoma is associated with a greater risk of developing a complication. The use of a graded surgical complication scale is needed for better reporting and comparison of complications. Achieving an R0 resection should still be considered the goal, even in locally advanced gastric cancer, but resection of additional organs should be performed judiciously.

Background Stenting across the gastroesophageal (GE) junction for adenocarcinoma has historically been contraindicated secondary to the concerns for severe GE reflux (GER) symptoms. The aim of this study was to assess reflux symptoms and quality of life (QOL) effects in patients undergoing esophageal stenting across the GE junction. Study Design We performed a prospective single arm QOL clinical trial evaluating patients with stage 2/3 GE junction adenocarcinoma, undergoing neoadjuvant therapy (from baseline to 10 weeks post-stenting) after stenting across the GE junction, for GER symptoms and QOL-GER assessments (EORTC-QLQ-O25 and Functional Assessment of Cancer Therapy-Esophageal [FACT-E]). Results Forty consecutive patients were enrolled in this clinical trial. The median age was 62 years (range 47 to 83 years); 84% were male and 19% were female patients. Median dysphagia score of 3 (only liquids tolerated) pre-stent was significantly improved to a score of 0 (ability to eat all foods) post-stent (p = 0.01). There was a significantly improved and sustained swallowing QOL from 2 weeks up to 10 weeks post-stent. The GER-QOL scores were similar 2 weeks post-stent, but were significantly improved throughout the rest of the study. Proton pump inhibitors were being used in 58% of patients pre-stent and in 85% of patients at 2- to 10-week follow-up. Planned chemotherapy and/or chemo-radiation therapy was completed in 95% of all patients. Stent migration (radiologic and/or complete) was seen in 63% of patients at some time during their therapy and corresponded to pathologic response in 85% of those patients. Conclusions Esophageal stenting across the GE junction remains the optimal therapy for dysphagia relief in esophageal malignancies and does not adversely affect a patient's GER-QOL. Esophageal stenting across the GE junction is not contraindicated and should be the initial therapy in patient management.

Background Controversy exists regarding the value and indications for inguinal dissection alone or in combination with an iliac/obturator lymph node dissection for melanoma. Study Design We reviewed patients from a multicenter prospective clinical trial and a single center who underwent inguinal dissection alone or combined with an iliac/obturator dissection for cutaneous melanoma. Analyses were stratified and compared by microscopic or macroscopic (palpable or detected by imaging) disease. Results The study was composed of 134 patients with a median follow-up of 39 months. Indications for inguinal dissection were microscopic disease in 94 (70%) patients and macroscopic nodal disease in 40 (30%) patients. An iliac/obturator dissection yielded tumor-positive pelvic nodes in 25% vs 55% in the microscopic vs macroscopic groups, respectively (p = 0.10). No risk factors for positive pelvic nodes were identified. For both microscopic and macroscopic disease, addition of an iliac/obturator dissection to an inguinal dissection did not significantly reduce the risk of pelvic nodal recurrence. Five-year overall survival rates for 4 groups were compared: microscopic disease, inguinal dissection alone (72%); microscopic disease, iliac/obturator dissection (68%); macroscopic disease, inguinal dissection alone (51%); and macroscopic disease, iliac/obturator dissection (44%) (p = 0.0163). On survival analysis, addition of an iliac/obturator dissection in either microscopic or macroscopic disease did not affect disease-free survival or regional lymph node recurrence-free survival. Conclusions The addition of an iliac/obturator dissection to an inguinal dissection for both microscopic and macroscopic nodal disease did not significantly affect lymph node recurrence rates, disease-free survival, or overall survival.

Background Intraoperative evaluation of successful pancreatic tumor ablation using irreversible electroporation (IRE) is difficult secondary to lack of visual confirmation. The IRE generator provides feedback by reporting current (amperage), which can be used to calculate changes in tumor tissue resistance. The purpose of the study was to determine if resistance can be used to predict successful tumor ablation during IRE for pancreatic cancers. Study Design All patients undergoing pancreatic IRE from March 2010 to December 2012 were evaluated using a prospective database. Intraoperative information, including change in tumor resistance during ablation and slope of the resistance curve, were used to evaluate effectiveness of tumor ablation in terms of local failure or recurrence (LFR) and disease-free survival (DFS). Results A total of 65 patients underwent IRE for locally advanced pancreatic cancer. Median follow-up was 23 months. Local failure or recurrence was seen in 17 patients at 3, 6, or 9 months post IRE. Change in tumor tissue resistance and the slope of the resistance curve were both significant in predicting LFR (p = 0.02 and p = 0.01, respectively). The median local disease-free survival was 5.5 months in patients who had recurrence compared with 12.6 months in patients who did not recur (p = 0.03). Neither mean change in tumor tissue resistance nor the slope of the resistance curve significantly predicted overall DFS. Conclusions Mean change in tumor tissue resistance and the slope of the resistance curve could be used intraoperatively to assess successful tumor ablation during IRE. Larger sample size and longer follow-up are needed to determine if these parameters can be used to predict DFS.

Background Recent studies have suggested that sentinel lymph node (SLN) biopsy is of limited value in desmoplastic melanoma. This study was performed to compare the rate of positive SLN biopsy in the Surveillance, Epidemiology, and End Results (SEER) database with that of a multi-institutional clinical trial and to investigate relevant prognostic factors in desmoplastic melanoma. Study Design Patients with desmoplastic melanoma ≥1.0 mm Breslow thickness, who underwent SLN biopsy in a multi-institutional prospective clinical trial, were combined with a single institution melanoma database (combined database) and compared with patients from the SEER database (1998 to 2009). Disease-free survival (DFS) and overall survival (OS) were summarized using Kaplan-Meier curves and compared using Cox proportional hazard models. Results The rate of positive SLN in the combined database was 17.0% (8 of 47). By comparison, the rate of positive SLN in SEER was lower: 2.5% (15 of 594). On multivariable analysis, Breslow thickness ≥2.6 mm (hazard ratio 8.17, 95% CI 1.26 to 160.1; p = 0.0259) and an interaction between SLN status and ulceration (p = 0.0013) were independent risk factors for worse OS in the combined database; patients with ulceration and a positive SLN had significantly worse OS. In the combined database on multivariable analysis, SLN positivity (p = 0.0161) and ulceration (p = 0.0004) were independent risk factors for worse DFS. Conclusions The rate of positive SLN in desmoplastic melanoma may be higher than that reported in the SEER database. Sentinel lymph node biopsy may be considered as part of the comprehensive staging of desmoplastic melanoma ≥1.0 mm Breslow thickness.

Background The Response Evaluation Criteria in Solid Tumors (RECIST), which evaluates maximum tumor diameter only, is commonly used to determine response to chemotherapy in patients with colorectal liver metastases. Limitations of RECIST include its inability to assess the changes in tumor enhancement. The aim of this study was to assess the correlation of these criteria as well as the modified RECIST (mRECIST) with pathologic tumor response. A novel semi-automated volumetric assessment of tumor size was also investigated. Study Design A review of a 1,948-patient prospective hepatic database to assess response and pathologic criteria was performed. Patients undergoing preoperative chemotherapy before hepatic resection for colorectal liver metastases were reviewed. Radiographic responses according to RECIST and mRECIST were determined. The percentage of viable tumor cells compared with the total tumor area was determined from the pathologic specimens. Results We identified 38 patients with adequate imaging who had undergone anatomic hepatic resection and full pathologic evaluation. The percentages of residual viable tumor in the resected specimens were significantly different across RECIST categories (p = 0.045), but not mRECIST (p = 0.305). For mRECIST, there were improved and significant linear trends for residual viable tumor, necrosis, and necrosis + fibrosis when compared with RECIST (p = 0.056). Neither RECIST nor mRECIST responses were predictive of residual viable tumor burden in regression analyses. A novel semi-automated volumetric assessment of tumor size correlated well with pathologic tumor size. Conclusions Neither RECIST nor mRECIST were predictive of residual viable burden, although the linear trend for mRECIST and residual necrosis + fibrosis compared favorably with RECIST. Continued evaluation for tumor enhancement and standardization of tumor size remain a critical unmet need in patients with solid organ disease.

Background Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. Study Design We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. Results Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. Conclusions IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012.

The optimal method for classifying lymph node (LN) status in breast cancer patients is unknown. We sought to determine if LN ratio (LNR) improves axillary staging.Kentucky Cancer Registry data (1996 to 2007) were used to compare LN categorization schemas. Overall survival (OS) was evaluated using the Kaplan-Meier method and log rank tests. Schemas included: LN positive (+) vs negative (-) disease, current American Joint Committee on Cancer (AJCC) staging (0 vs 1 to 3 vs 4 to 9 vs ≥10 LN+), and LNR 0 vs 0.01 to 0.20 vs 0.21 to 0.65 vs0.65 (LN- vs low, intermediate, and high risk LN+ groups).There were 1,436 patients who had complete LN evaluation data: 880 (61.3%) were LN- and 556 (39.6%) were LN+; 309 (21.5%) had 1 to 3 positive LNs, 138 (9.6%) had 4 to 9 positive LNs, and 109 (7.6%) had 10 or more positive LNs. For LN+ patients, the median number of positive LNs was 3; median LNR was 0.23. The median follow-up was 65 months. LN status was associated with 5-year OS (91.3% and 73.3% for LN- and LN+ groups, respectively, p0.001). Increasing AJCC pN stage was associated with worse OS (5-year OS 80.5%, 75.3%, and 49.8% for pN1 to N3, respectively, p0.001). LNR was also associated with OS (5-year OS of 83.1%, 72.7%, and 52.7% for the low, intermediate, and high risk LN+ groups, respectively, p0.001). In subgroup analyses of patients in the 1 to 3 and 4 to 9 LN+ groups, OS was statistically associated with LNR (p = 0.021 and p = 0.016, respectively). On multivariable survival analysis, LNR was associated with OS, independent of AJCC categorization, p = 0.003.LNR was associated with OS, regardless of AJCC LN categories.

Background Hepatic intra-arterial therapy for unresectable hepatocellular cancer (HCC) has been shown to improve overall survival, but can have significant toxicity. A recent prospective randomized controlled trial demonstrated superior response rates and significantly less morbidity and doxorubicin-related adverse events with drug-eluting beads with doxorubicin (DEBDOX) compared with conventional chemoembolization. The aim of this study was to confirm the efficacy of DEBDOX for the treatment of unresectable HCC. Study Design This open-label, multicenter, multinational single-arm study included 118 intermediate-staged HCC patients who were not candidates for transplantation or resection. Patients received DEBDOX at each treatment. Complications and response rates to treatment were analyzed. Results There were 118 patients who received a total of 186 DEBDOX treatments with a median total treatment dose of 75 mg (range 38 to 150 mg), and median overall total hepatic exposure of 150 mg (range 150 to 600 mg). Five lesions were targeted, with a median size of 5.3 cm (range 1.0 to 16.9 cm). Severe adverse events related to liver dysfunction were seen after 4% of treatments. Overall survival was a median of 14.2 months (range 5 to 30 months), with progression-free survival of 13 months and hepatic-specific progression-free survival of 16 months. Okuda class less than 1 at time of treatment, reduction of alpha-fetoprotein of 1,000 ng/mL at the first post-treatment evaluation, delivery of more than 200 mg doxorubicin, and less than 25% liver involvement were all predictors of favorable overall survival assessed by multivariable analyses. Conclusions Hepatic intra-arterial injection of DEBDOX is safe and effective in the treatment of HCC, as demonstrated by a minimal complication rate and robust and durable tumor response.

As compared with open hepatic lobectomy (OHL), laparoscopic hepatic lobectomy (LHL) carries a substantial learning curve and potential for improved perioperative outcomes. The purpose of this analysis was to compare the outcomes of patients undergoing LHL with those of patients undergoing OHL.Analysis of a 1,545-patient prospective hepato-pancreatico-biliary database from January 2000 to June 2009 identified 450 hepatic lobectomy patients, in whom 90 were LHL. A 4:1 case-matched analysis comparing LHL with 360 OHL patients, controlling for age, American Society of Anesthesiologists class, tumor size, histology, and tumor location was performed.A total of 450 patients underwent hepatic lobectomy for malignant or benign lesions, with LHL performed in 90 (20%) patients. There was a significant increase in the percentage of LHL performed during 3 intervals of time: 1995 to 1999, 0%; 2000 to 2004, 1%; 2005 to 2009, 24% (p0.0001). There were no significant differences in age (60 versus 62 years), American Society of Anesthesiologists class, body mass index (28.1 versus 26.4), size of largest tumor (4.0 cm versus 6.4 cm), location of tumor(s), or number of tumors (1 versus 1) comparing LHL versus OHL, respectively. There were substantial differences in estimated blood loss, Pringle maneuver, transfusion requirements, complications, and length of stay. Proportional hazards model for all 450 patients demonstrated that OHL (odds ratio = 2.5; 95% CI, 1.2-8.7), blood transfusion, and blood loss were all independently associated with increased complications.In this prospective evaluation, LHL was associated with substantial improvements in operative time, Pringle maneuver time, blood loss, transfusion requirements, length of stay, and morbidity without compromising resection margins. These results suggest that LHL is appropriate in selected patients with hepatic tumors.

BACKGROUND: The aim of this study was to compare postoperative outcomes of patients with synchronous colorectal liver metastases treated with either simultaneous or staged colectomy and hepatectomy. STUDY DESIGN: From July 1997 to June 2008, a review of our 1,344-patient prospective hepato-pancreaticobiliary database identified 230 patients treated surgically for primary adenocarcinoma of the large bowel and synchronous hepatic metastasis. Clinicopathologic, operative, and perioperative data, complications, and grade of complications (grade 1, minor, to grade 5, death) were reviewed to evaluate selection criteria, operative methods, and perioperative outcomes. Chisquare and proportional hazard model were used to evaluate predictors of outcomes. RESULTS: Seventy patients underwent simultaneous resection of colon primary and liver metastasis in a single operation; 160 patients underwent staged operations. Simultaneous resections were similar for size (median 4 cm versus 3.7 cm) and number (median 3 cm versus 3 cm) of liver metastases. Major liver resections (3 Couinaud segments) were similar between staged and simultaneous (32% versus 33%, respectively), as was type of colectomy (p 0.2). Complication rates and severity were similar in both groups: 39 of 70 patients (56%) in the simultaneous groupexperienced63complicationsversus88of160patients(55%)with162complicationsin the staged group (p 0.24). Multivariate analysis identified blood transfusion as a predictor of complication (odds ratio 2.98, p 0.001). Patients having simultaneous resection required fewer days in the hospital (median 10 days versus 18 days, p 0.001). CONCLUSIONS: By avoiding a second laparotomy, simultaneous colon and hepatic resection reduces overall hospitalstay,withnodifferenceinmorbidityandmortalityratesorinseverityofcomplications, comparedwithstagedresection.Simultaneousresectionisanacceptableoptioninpatientswith resectable synchronous colorectal metastasis. (J Am Coll Surg 2009;208:842–852. © 2009 by the American College of Surgeons) Synchronous liver metastasis, commonly defined as liver metastasis occurring within 12 months of the colon primary, represents 13% to 25% of 90,000 newly diagnosed colorectal liver metastases. 1,2 Through the expansion of multidisciplinary care with advances in surgical training, surgical techniques (laparoscopy and ablation), anesthetic management, and chemotherapy, the overall survival of

BACKGROUND: The goal of this study was to examine the safety and efficacy of selective internal radioembolization (SIR) for hepatocellular carcinoma (HCC) with portal vein or caval thrombosis (VT), or both. Recent reports have demonstrated that SIR is safe for patients with HCC, but the impact on efficacy of venous thrombosis is unknown. STUDY DESIGN: Prospective single-arm study of the use of Therasphere in patients with unresectable HCC enrolled from January 2004 to June 2007. Patients were categorized into three groups based on VT status and therapy. RESULTS: Fifty-two patients were enrolled: 20 patients without VT who received SIR, 15 patients with VT who were treated, and 17 patients (10 with VT) who were not treated because of preprocedure screening failure. Fifty-eight treatments were administered, with a median of two treatments per patient (range of one to three treatments). Child's score was different between groups. Of the VT patients treated, 67% had portal VT, 7% had cava VT, and 26% had both. There were no treatment-related deaths. There was no difference in complications among groups (p = 0.34). Treated patients without thrombosis had a median overall survival of 13.9 months versus 2.7 months for those treated with thrombosis and 5.2 months for the untreated group given best supportive care only (p = 0.01). CONCLUSIONS: SIR is safe in patients with HCC. Although SIR can be delivered with minimal morbidity, there might be no benefit for patients with VT. Continued emphasis on multimodality therapy in this population is needed to improve survival.

The optimal surgical strategy for the treatment of synchronous resectable colorectal liver metastasis has not been defined. The aims of this study were to review our experience with synchronous colorectal metastasis and to define the safety of simultaneous versus staged resection of the colon and liver.From September 1984 through November 2001, 240 patients were treated surgically for primary adenocarcinoma of the large bowel and synchronous hepatic metastasis. Clinicopathologic, operative, and perioperative data were reviewed to evaluate selection criteria, operative methods, and perioperative outcomes.One hundred thirty-four patients underwent simultaneous resection of a colorectal primary and hepatic metastasis in a single operation (Group I), and 106 patients underwent staged operations (Group II). Simultaneous resections tend to be performed for right colon primaries (p0.001), smaller (p0.01) and fewer (p0.001) liver metastases, and less extensive liver resection (p0.001). Complications were less common in the simultaneous resection group, with 65 patients (49%) sustaining 142 complications, compared with 71 patients (67%) sustaining 197 complications for both hospitalizations in the staged resection group (p0.003). Patients having simultaneous resection required fewer days in the hospital (median 10 days versus 18 days, p = 0.001). Perioperative mortality was similar (simultaneous, n = 3; staged, n = 3).Simultaneous colon and liver resection is safe and efficient in the treatment of patients with colorectal cancer and synchronous liver metastasis. By avoiding a second laparotomy, the overall complication rate is reduced, with no change in operative mortality. Given its reduced morbidity, shorter treatment time, and similar cancer outcomes, simultaneous resection should be considered a safe option in patients with resectable synchronous colorectal metastasis.

Background Major hepatic resection is indicated for selected patients with colorectal metastasis to the liver. Transfusion of fresh frozen plasma (FFP) might be required after major hepatectomy because of blood loss or coagulopathy, but there are no standard criteria for the use of FFP in this setting. Methods We identified 260 patients from our prospective database who underwent major (≥3 Couinaud segments) hepatectomy between May 1997 and February 2001 for colorectal metastasis. FFP use was determined and tested for its relationship to clinical and pathologic factors. A survey on FFP use was sent to 12 other hepatobiliary centers worldwide. Results There were 142 (55%) men, 118 (45%) women, and the median age was 63 years. The most common hepatic resections performed were right lobectomy (37%) and extended right lobectomy (33%). There were 83 (32%) patients who received FFP. In these patients, a total of 405 units of FFP were administered with a median of 4 units. The majority of patients who received FFP were transfused within the first two postoperative days, while there were only five (2%) patients who initially received FFP beyond that time. FFP was administered for a median prothrombin time of 16.9. Only one (0.4%) patient required reoperation for bleeding. Right lobectomy and extended right lobectomy were found to predict FFP use on multivariate analysis. Postoperative complications did not correlate with FFP use. The criteria used for FFP administration at other major hepatobiliary centers were found to be variable. Conclusions There is no universal standard for FFP use following major hepatic resection for colorectal metastasis. Our criterion of a prothrombin time of 16–18 seconds is conservative but results only rarely in reoperation for bleeding. Prospective evaluation of a higher threshold for FFP administration, such as an International Normal Ratio of 2.0, should be performed to better define the guidelines for FFP use in patients undergoing major hepatectomy who have normal underlying hepatic parenchyma.

BACKGROUND: Evaluation of peritoneal cytology provides valuable staging information in patients with gastric and pancreatic adenocarcinoma, but its usefulness in patients with extrahepatic cholangiocarcinoma is unclear. The aim of this study was to evaluate the predictive value of peritoneal cytology in patients with potentially resectable hilar cholangiocarcinoma. This study evaluated a possible association between positive peritoneal cytology and percutaneous transhepatic biliary drainage, which is commonly used in these patients and may result in peritoneal biliary leakage and peritoneal seeding. STUDY DESIGN: From October 1997 through June 2000 26 patients with hilar cholangiocarcinoma underwent staging laparoscopy immediately before planned open exploration and resection. Peritoneal washings were obtained during laparoscopic examination before any biopsies were taken. Cytologic analysis was performed using the Papanicolau technique. RESULTS: There were 18 men and 8 women, with a median age of 69 years (range 42 to 81 years). The most common presenting symptom was jaundice (n = 19). Previous biliary drainage was performed in 23 patients: 9 percutaneous and 14 endoscopic. Metastatic disease was suspected preoperatively in six patients, three to the liver, two to the peritoneum, and one to regional lymph nodes, all of which were confirmed at laparoscopy. Laparoscopy identified five additional patients with metastatic disease. Peritoneal cytology was positive for malignant cells in two patients, both of whom had gross peritoneal metastases. Nine other patients had metastatic disease to distant sites within the abdomen, but none had positive cytology. Overall, six patients had metastatic disease to the peritoneal cavity, only one of whom had undergone earlier percutaneous biliary drainage. CONCLUSIONS: Peritoneal cytology was not predictive of occult metastatic disease. Laparoscopic staging identified some patients with unresectable hilar cholangiocarcinoma, but analysis of peritoneal cytology provided no additional information. There was no association between percutaneous transhepatic biliary drainage and peritoneal tumor seeding.