Using the Comprehensive Complication Index to Rethink the ISGLS Criteria for Post-hepatectomy Liver Failure in an International Cohort of Major Hepatectomies.

OBJECTIVE: To compare different criteria for post-hepatectomy liver failure (PHLF) and evaluate the association between International Study Group of Liver Surgery (ISGLS) PHLF and the Comprehensive Complication Index (CCI)" and 90-day mortality. SUMMARY OF BACKGROUND DATA: PHLF is a serious complication following hepatic resection. Multiple criteria have been developed to characterize PHLF. METHODS: Adults who underwent major hepatectomies at twelve international centers (2010-2020) were included. We identified patients who met criteria for PHLF based on three definitions: 1) ISGLS, 2) Balzan (INR > 1.7 and bilirubin > 2.92mg/dL) or 3) Mullen (peak bilirubin >7mg/dL). We compared the 90-day mortality and major morbidity predicted by each definition. We then used logistic regression to determine the odds of CCI>40 and 90-day mortality associated with ISGLS grades. RESULTS: Among 1646 included patients, 19 (1.1%) met Balzan, 68 (4.1%) met Mullen, and 444 (27.0%) met ISGLS criteria for PHLF. Of the three definitions, the ISGLS criteria best predicted 90-day mortality (AUC = 0.72; sensitivity 69.4%). Patients with ISGLS grades B&C were at increased odds of CCI > 40 (grade B OR 4.0; 95% CI: 2.2-7.2; grade C OR 137.0; 95% CI: 59.2-317.4). Patients with ISGLS grade C were at increased odds of 90-day mortality (OR 113.6; 95% CI: 55.6-232.1). Grade A was not associated with CCI> 40 or 90-day mortality. CONCLUSIONS: In this diverse international cohort of major hepatectomies, ISGLS grade A was not associated with 90-day mortality or high CCI, calling into question the current classification of patients in this group as having clinically significant PHLF.

Development and Validation of Prediction Models and Risk Calculators for Posthepatectomy Liver Failure and Postoperative Complications Using a Diverse International Cohort of Major Hepatectomies.

OBJECTIVE: The study aim was to develop and validate models to predict clinically significant posthepatectomy liver failure (PHLF) and serious complications [a Comprehensive Complication Index (CCI)>40] using preoperative and intraoperative variables. BACKGROUND: PHLF is a serious complication after major hepatectomy but does not comprehensively capture a patient's postoperative course. Adding the CCI as an additional metric can account for complications unrelated to liver function. METHODS: The cohort included adult patients who underwent major hepatectomies at 12 international centers (2010-2020). After splitting the data into training and validation sets (70:30), models for PHLF and a CCI>40 were fit using logistic regression with a lasso penalty on the training cohort. The models were then evaluated on the validation data set. RESULTS: Among 2192 patients, 185 (8.4%) had clinically significant PHLF and 160 (7.3%) had a CCI>40. The PHLF model had an area under the curve (AUC) of 0.80, calibration slope of 0.95, and calibration-in-the-large of -0.09, while the CCI model had an AUC of 0.76, calibration slope of 0.88, and calibration-in-the-large of 0.02. When the models were provided only preoperative variables to predict PHLF and a CCI>40, this resulted in similar AUCs of 0.78 and 0.71, respectively. Both models were used to build 2 risk calculators with the option to include or exclude intraoperative variables ( PHLF Risk Calculator; CCI>40 Risk Calculator ). CONCLUSIONS: Using an international cohort of major hepatectomy patients, we used preoperative and intraoperative variables to develop and internally validate multivariable models to predict clinically significant PHLF and a CCI>40 with good discrimination and calibration.

Neoadjuvant Therapy Versus Upfront Resection for Nonpancreatic Periampullary Adenocarcinoma.

BACKGROUND: In contrast to pancreatic ductal adenocarcinoma (PDAC), neoadjuvant therapy (NAT) for periampullary adenocarcinomas is not well studied, with data limited to single-institution retrospective reviews with small cohorts. We sought to compare outcomes of NAT versus upfront resection (UR) for non-PDAC periampullary adenocarcinomas. PATIENTS AND METHODS: Using the National Cancer Database (NCDB), we identified patients who underwent surgery for extrahepatic cholangiocarcinoma, ampullary adenocarcinoma, or duodenal adenocarcinoma from 2006 to 2016. We compared outcomes between NAT versus UR groups for each tumor subtype with 1:3 propensity score matching. Cox regression was used to identify predictors of survival. RESULTS: Among 7656 patients who underwent resection for non-PDAC periampullary adenocarcinoma, the proportion of patients who received NAT increased from 6 to 11% for cholangiocarcinoma (p < 0.01), 1 to 4% for ampullary adenocarcinoma (p = 0.01), and 5 to 8% for duodenal adenocarcinoma (p = 0.08). Length of stay, readmission, and 30-day mortality were comparable between NAT and UR. All tumor subtypes were downstaged following NAT (p < 0.01). The R0 resection rate was significantly higher in patients with extrahepatic cholangiocarcinoma who received NAT, and these patients had improved median overall survival (38 vs 26 months, p < 0.001). After adjustment for clinicopathologic factors and adjuvant chemotherapy, use of NAT was associated with improved survival in patients with cholangiocarcinoma [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.54-0.89, p = 0.004] but not duodenal or ampullary adenocarcinoma. The survival advantage for cholangiocarcinoma persisted after propensity matching. CONCLUSION: This national cohort analysis suggests, for the first time, that neoadjuvant therapy is associated with improved survival in patients with extrahepatic cholangiocarcinoma.

National Practice Patterns in Malignant Peritoneal Mesothelioma: Updates in Management and Survival.

BACKGROUND: Malignant peritoneal mesothelioma (MPM) is a rare malignancy with a historically poor prognosis. Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) has emerged as an effective therapy for patients with peritoneal malignancies. A contemporary analysis of trends in management of and survival from MPM is warranted. METHODS: Patients with MPM were identified from the National Cancer Database (2004-2018). Patients were categorized by treatment (CRS-HIPEC, CRS-chemotherapy, CRS only, chemotherapy only, no treatment), and joinpoint regression was employed to compute the annual percent change (APC) in treatment over time. Multivariable Cox proportional hazards models were used to analyze factors associated with survival. RESULTS: Of 2683 patients with MPM, 19.1% underwent CRS-HIPEC, and 21.1% received no treatment. Joinpoint regression revealed a statistically significant increase in the proportion of patients undergoing CRS-HIPEC over time (APC 3.21, p = 0.01), and a concurrent decrease in the proportion of patients who underwent no treatment (APC - 2.21, p = 0.02). Median overall survival was 19.5 months. Factors independently associated with survival included CRS-HIPEC, CRS, histology, sex, age, race, Charlson Comorbidity Index, insurance, and hospital type. Although there was a strong association between year of diagnosis and survival on univariate analysis (2016-2018 HR 0.67, p < 0.001), this association was attenuated after adjustment for treatment. CONCLUSIONS: CRS-HIPEC is increasingly employed as a treatment for MPM. In parallel, there has been a decrease in patients receiving no treatment with an increase in overall survival. These findings suggest that patients with MPM may be receiving more appropriate therapy; however, a substantial proportion of patients may remain undertreated.

Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

Neoadjuvant Chemotherapy for Pancreatic Adenocarcinoma Lessens the Deleterious Effect of Omission of Adjuvant Chemotherapy.

BACKGROUND: Despite controversy regarding the role of neoadjuvant chemotherapy (NAC) in pancreatic adenocarcinoma, nearly half of resected patients do not receive chemotherapy postoperatively. This study aimed to examine whether use of NAC compensates for omission of adjuvant chemotherapy (AC) for resected pancreatic adenocarcinoma. METHODS: Adults with resected stages 1 to 3 pancreatic adenocarcinoma were enrolled from the National Cancer Database NCDB (2006-2016). Overall survival (OS) analyses were used to examine the impact of NAC on those who did not receive AC. RESULTS: The study analyzed a national cohort of 56,286 patients: 30% without chemotherapy, 11% with NAC, 54% with AC, and 5% with NAC plus AC. Use of NAC increased by more than 400% from 2006 to 2016, whereas the rates for omission of chemotherapy remained unchanged. The OS rates were similar between the patients who received NAC and those who received AC (hazard ratio, 0.97; p = 0.21). Among the patients who did not receive AC, NAC was associated with improved OS (26.7 vs. 18.4 months; p < 0.0001). The patients who did not receive AC but underwent NAC had a median OS comparable with the OS of those who received AC alone (26.9 vs. 24.7 months). In the adjusted analysis, the use of NAC for those without AC was significantly associated with improved OS (estimate, - 0.24; p < 0.0001). CONCLUSIONS: Although data are limited regarding the survival benefit derived from neoadjuvant versus adjuvant chemotherapy in pancreatic adenocarcinoma, nearly half of patients do not receive adjuvant chemotherapy. This study demonstrates that the use of NAC lessens the survival disadvantage caused by omission of AC. Despite controversy, NAC may be considered for pancreatic adenocarcinoma patients given the high likelihood that adjuvant chemotherapy will be omitted.

Safety and oncologic efficacy of robotic compared to open pancreaticoduodenectomy after neoadjuvant chemotherapy for pancreatic cancer.

BACKGROUND: Emerging data from multi-institutional and national databases suggest that robotic pancreaticoduodenectomy is safe and feasible for pancreatic adenocarcinoma. Nevertheless, there are limited reports evaluating its safety and oncologic efficacy following neoadjuvant chemotherapy. METHOD: This is a retrospective study from the 2010-2016 National Cancer Database comparing the postoperative, pathological and long-term oncologic outcomes between robotic pancreaticoduodenectomy (RPD) and open pancreaticoduodenectomy (OPD) for pancreatic adenocarcinoma following neoadjuvant chemotherapy. RESULTS: We identified 155 (5%) RPD and 3329 (95%) OPD following neoadjuvant chemotherapy. The use of the robot increased from 3 cases in 2010 to 50 cases in 2016. RPD patients were more likely to receive adjuvant chemotherapy and to be treated at academic centers. After adjustment, RPD was associated with a higher proportion of adequate lymphadenectomy, receipt of adjuvant chemotherapy, decreased rate of prolonged length of stay, and similar 90-day mortality. There was no difference in median overall survival between RPD and OPD (25.6 months vs. 27.5 months, Log Rank p = 0.879). The 1-, 3- and 5-year overall survival rates for RPD were 83%, 36% and 22% and for OPD were 86%, 38% and 22%. After adjustment, the use of robotic surgery was associated with similar overall survival compared to the open approach (HR 1.011, 95% confidence interval (CI) 0.776-1.316). CONCLUSIONS: Following neoadjuvant chemotherapy, RPD is associated with similar short- and long-term mortality with the advantage of shorter length of stay, higher proportion of adequate lymphadenectomy and receipt of adjuvant chemotherapy.

Long-term survival following minimally invasive extended cholecystectomy for gallbladder cancer: A 7-year experience from the National Cancer Database.

BACKGROUND: Open extended cholecystectomy (O-EC) has long been the recommended treatment for resectable gallbladder cancer (GBC), while the minimally-invasive approach for EC (MIS-EC) remains controversial. Our aim was to analyze overall survival of GBC patients treated with MIS-EC vs O-EC at the national level. METHODS: A retrospective review of the National Cancer Database of patients with resectable GBC (2010-2016) and treated with either MIS-EC or O-EC was performed. Overall survival (OS) was compared by the surgical approach. RESULTS: A total of 680 patients were identified, of whom 235 (34.6%) underwent MIS-EC. There were no differences in the rates of positive margins between MIS-EC and O-EC (14% vs 19%, respectively; P = .278), and in the mean lymph node yield (6.54 vs 6.66, respectively; P = .914). The median survival following MIS-EC was significantly higher than that of O-EC (39 vs 26 months; P = .048). After stratification by pathological stage and after adjustment, there was no significant difference in OS between the groups (HR = 0.9, 95% CI, 0.6-1.5). CONCLUSION: In this large national cohort, MIS-EC oncologic outcomes were noninferior to the O-EC. Proficiency with MIS techniques, proper patient selection, and referral to specialized centers may allow a greater benefit from this treatment modality.

Insurance Status, Not Race, is Associated With Use of Minimally Invasive Surgical Approach for Rectal Cancer.

OBJECTIVE: To determine the impact of race and insurance on use of minimally invasive (MIS) compared with open techniques for rectal cancer in the United States. BACKGROUND: Race and socioeconomic status have been implicated in disparities of rectal cancer treatment. METHODS: Adults undergoing MIS (laparoscopic or robotic) or open rectal resections for stage I to III rectal adenocarcinoma were included from the National Cancer Database (2010-2012). Multivariate analyses were employed to examine the adjusted association of race and insurance with use of MIS versus open surgery. RESULTS: Among 23,274 patients, 39% underwent MIS and 61% open surgery. Overall, 86% were white, 8% black, and 3% Asian. Factors associated with use of open versus MIS were black race, Medicare/Medicaid insurance, and lack of insurance. However, after adjustment for patient demographic, clinical, and treatment characteristics, black race was not associated with use of MIS versus open surgery [odds ratio [OR] 0.90, P = 0.07). Compared with privately insured patients, uninsured patients (OR 0.52, P < 0.01) and those with Medicare/Medicaid (OR 0.79, P < 0.01) were less likely to receive minimally invasive resections. Lack of insurance was significantly associated with less use of MIS in black (OR 0.59, P = 0.02) or white patients (OR 0.51, P < 0.01). However, among uninsured patients, black race was not associated with lower use of MIS (OR 0.96, P = 0.59). CONCLUSIONS: Insurance status, not race, is associated with utilization of minimally invasive techniques for oncologic rectal resections. Due to the short-term benefits and cost-effectiveness of minimally invasive techniques, hospitals may need to improve access to these techniques, especially for uninsured patients.

Is There a Minimum Number of Thyroidectomies a Surgeon Should Perform to Optimize Patient Outcomes?

OBJECTIVE: To determine the number of total thyroidectomies per surgeon per year associated with the lowest risk of complications. BACKGROUND: The surgeon volume-outcome association has been established for thyroidectomy; however, a threshold number of cases defining a "high-volume" surgeon remains unclear. METHODS: Adults undergoing total thyroidectomy were identified from the Health Care Utilization Project-National Inpatient Sample (1998-2009). Multivariate logistic regression with restricted cubic splines was utilized to examine the association between the number of annual total thyroidectomies per surgeon and risk of complications. RESULTS: Among 16,954 patients undergoing total thyroidectomy, 47% had thyroid cancer and 53% benign disease. Median annual surgeon volume was 7 cases; 51% of surgeons performed 1 case/y. Overall, 6% of the patients experienced complications. After adjustment, the likelihood of experiencing a complication decreased with increasing surgeon volume up to 26 cases/y (P < 0.01). Among all patients, 81% had surgery by low-volume surgeons (≤25 cases/y). With adjustment, patients undergoing surgery by low-volume surgeons were more likely to experience complications (odds ratio 1.51, P = 0.002) and longer hospital stays (+12%, P = 0.006). Patients had an 87% increase in the odds of having a complication if the surgeon performed 1 case/y, 68% for 2 to 5 cases/y, 42% for 6 to 10 cases/y, 22% for 11 to 15 cases/y, 10% for 16 to 20 cases/y, and 3% for 21 to 25 cases/y. CONCLUSIONS: This is the first study to identify a surgeon volume threshold (>25 total thyroidectomies/y) that is associated with improved patient outcomes. Identifying a threshold number of cases defining a high-volume thyroid surgeon is important, as it has implications for quality improvement, criteria for referral and reimbursement, and surgical education.

Alvimopan Provides Additional Improvement in Outcomes and Cost Savings in Enhanced Recovery Colorectal Surgery.

OBJECTIVE: To examine the impact of alvimopan on outcomes and costs in a rigorous enhanced recovery colorectal surgery protocol. BACKGROUND: Postoperative ileus remains a major source of morbidity and costs in colorectal surgery. Alvimopan has been shown to reduce incidence of postoperative ileus in enhanced recovery colorectal surgery; however, data are equivocal regarding its benefit in reducing length of stay and costs. METHODS: Patients undergoing major elective enhanced recovery colorectal surgery were identified from a prospectively-collected database (2010-2013). Multivariable analyses were employed to compare outcomes and hospital costs among patients who had alvimopan versus no alvimopan by adjusting for demographic, clinical, and treatment characteristics. RESULTS: A total of 660 patients were included; 197 patients received alvimopan and 463 patients had no alvimopan. In unadjusted analysis, the alvimopan group had a faster return of bowel function, shorter length of stay, and lower rates of ileus, Foley re-insertion, and urinary tract infection (all P < 0.01). After adjustment, alvimopan was associated with a faster return of bowel function by 0.6 day (P = 0.0006), and lower incidence of postoperative ileus (odds ratio 0.23, P = 0.0002). With adjustment, alvimopan was associated with a shorter length of stay by 1.6 days (P = 0.002), and a hospital cost savings of $1492 per patient (P = 0.01). CONCLUSIONS: Alvimopan administration as an element of enhanced recovery colorectal surgery is associated with faster return of bowel function, lower incidence of postoperative ileus, shorter hospitalization, and a significant cost savings. These results suggest that alvimopan is cost-effective in the setting of enhanced recovery colorectal surgery protocols, and should therefore be considered in these programs.

Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients.

OBJECTIVES: To describe national practice patterns regarding utilization of minimally invasive pancreaticoduodenectomy (MIPD) and compare short-term outcomes with those following open pancreaticoduodenectomy for cancer. BACKGROUND: There is increasing interest in use of MIPD; however, published data are limited to single institutional experiences. METHODS: Adult patients undergoing pancreaticoduodenectomy were identified from the National Cancer Database, 2010-2011. Descriptive statistics and multivariable modeling were employed to characterize use of MIPD (laparoscopic or robotic) and compare short-term outcomes to those following open pancreaticoduodenectomy. RESULTS: A total of 7061 patients underwent pancreaticoduodenectomy: 983 had MIPD and 6078 had open procedures. The use of MIPD increased by 45% (179 cases) from 2010 to 2011. The majority of hospitals (92%) performing MIPD were low volume (≤ 10 cases/2 years). Factors independently associated with undergoing MIPD included fewer comorbidities, treatment at an academic institution, and a neuroendocrine tumor diagnosis (all P < 0.01). The unadjusted 30-day mortality rate was 5.1% for MIPD versus 3.1% after open surgery. For patients with adenocarcinoma, there were no differences between MIPD and open pancreaticoduodenectomy after multivariable adjustment in number of lymph nodes removed, rate of positive surgical margins, length of stay, or readmissions. However, 30-day mortality was higher for patients undergoing MIPD versus open surgery (odds ratio = 1.87, confidence interval: 1.25-2.80, P = 0.002). CONCLUSIONS: While there is increasing interest in employing MIPD for adenocarcinoma, its use is associated with increased 30-day mortality. The majority of hospitals performing MIPD were low volume. These results may suggest that MIPD is a complex procedure for which comprehensive protocols outlining criteria for implementation might be warranted to optimize patient safety.

Impact of Timeliness of Resection and Thyroidectomy Margin Status on Survival for Patients with Anaplastic Thyroid Cancer: An Analysis of 335 Cases.

BACKGROUND: Controversies regarding anaplastic thyroid cancer (ATC) surround aggressiveness of tumor resection in the presence of extrathyroidal extension and the impact of delayed surgery on patient survival. Our goal was to analyze the survival implications of complete and timely resections. METHODS: Adult patients with ATC were culled from the National Cancer Data Base for the years 2003-2006. Kaplan-Meier curves and Cox proportional hazard regression analyses were used for univariate and multivariate survival analyses, respectively. RESULTS: A total of 680 ATC patients were identified. In the surgical cohort (n = 335), the female-to-male ratio was 1.6:1; mean age was 68.6 years. Patients with ATCs were staged as IVA in 42.7 % of cases, IVB in 32.2 %, and IVC in 25.1 %. Median time from diagnosis to surgery was 15 days. Negative margin status was more often achieved in patients diagnosed with stage IVA disease (p < 0.001). Compared to surgical patients, those who did not receive thyroid resections were older and had a more advanced stage of disease (both p < 0.001). In multivariable analyses, positive margin status was associated with increased mortality in stage IVA ATC (p = 0.017) but had no survival impact in stages IVB and IVC (p > 0.05). After adjustment for possible confounders, increasing time from diagnosis to surgery was not found to be associated with compromised survival outcomes for any disease stage. CONCLUSIONS: Timely and aggressive surgical management should be pursued in patients with intrathyroidal disease; however, aggressive resections may not be recommended for patients with stage IVB and IVC disease when morbidity and operative risks outweigh the limited benefits of surgery.

Minimally Invasive Distal Pancreatectomy for Cancer: Short-Term Oncologic Outcomes in 1,733 Patients.

BACKGROUND: Data from high-volume institutions suggest that minimally invasive distal pancreatectomy (MIDP) provides favorable perioperative outcomes and adequate oncologic resection for pancreatic cancer; however, these outcomes may not be generalizable. This study examines patterns of use and short-term outcomes from MIDP (laparoscopic or robotic) versus open distal pancreatectomy (ODP) for pancreatic adenocarcinoma in the United States. METHODS: Adult patients undergoing distal pancreatectomy were identified from the National Cancer Database, 2010-2011. Multivariable modeling was applied to compare short-term outcomes from MIDP versus ODP for pancreatic adenocarcinoma. RESULTS: 1733 patients met inclusion criteria: 535 (31 %) had MIDP and 1198 (69 %) ODP. Use of MIDP increased 43 % between 2010 and 2011; the conversion rate from MIDP to ODP was 23 %. MIDP cases were performed at 215 hospitals, with 85 % of hospitals performing <10 cases overall. After adjustment, pancreatic adenocarcinoma patients undergoing MIDP versus ODP had a similar likelihood of complete resection (OR 1.48, p = 0.10), number of lymph nodes removed (RR 1.01, p = 0.91), and 30-day readmission rate (OR 1.02, p = 0.96); however, length of stay was shorter (RR 0.84, p < 0.01). CONCLUSIONS: Use of MIDP for cancer is increasing, with most centers performing a low volume of these procedures. Use of MIDP for body and tail pancreatic adenocarcinoma appears to have short-term outcomes that are similar to those of open procedures with the benefit of a shorter hospital stay. Larger studies with longer follow-up are needed.

Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients.

OBJECTIVE: To examine the association between the extent of surgery and overall survival in a large contemporary cohort of patients with papillary thyroid cancer (PTC). BACKGROUND: Guidelines recommend total thyroidectomy for PTC tumors >1 cm, based on older data demonstrating an overall survival advantage for total thyroidectomy over lobectomy. METHODS: Adult patients with PTC tumors 1.0-4.0 cm undergoing thyroidectomy in the National Cancer Database, 1998-2006, were included. Cox proportional hazards models were applied to measure the association between the extent of surgery and overall survival while adjusting for patient demographic and clinical factors, including comorbidities, extrathyroidal extension, multifocality, nodal and distant metastases, and radioactive iodine treatment. RESULTS: Among 61,775 PTC patients, 54,926 underwent total thyroidectomy and 6849 lobectomy. Compared with lobectomy, patients undergoing total thyroidectomy had more nodal (7% vs 27%), extrathyroidal (5% vs 16%), and multifocal disease (29% vs 44%) (all Ps < 0.001). Median follow-up was 82 months (range, 60-179 months). After multivariable adjustment, overall survival was similar in patients undergoing total thyroidectomy versus lobectomy for tumors 1.0-4.0 cm [hazard ratio (HR) = 0.96; 95% confidence interval (CI), 0.84-1.09); P = 0.54] and when stratified by tumor size: 1.0-2.0 cm [HR = 1.05; 95% CI, 0.88-1.26; P = 0.61] and 2.1-4.0 cm [HR = 0.89; 95% CI, 0.73-1.07; P = 0.21]. Older age, male sex, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (P < 0.0001). CONCLUSIONS: Current guidelines suggest total thyroidectomy for PTC tumors >1 cm. However, we did not observe a survival advantage associated with total thyroidectomy compared with lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.