Understanding futility in pancreaticoduodenectomy: Insights from a national cohort.

BACKGROUND AND OBJECTIVES: Pancreaticoduodenectomy (PD), the only surgical option for right-sided pancreatic ductal adenocarcinoma (PDAC), carries significant morbidity. Not all patients may be deriving a survival benefit from this operation. We sought to identify the rate of futile PD and its associated factors in a large national cohort. METHODS: We performed a retrospective analysis using the National Cancer Database (2004-2020), including all patients who underwent PD for non-metastatic PDAC. The primary outcome was operative futility, which was defined as death within 12 months of diagnosis despite PD. Multivariable regression was used to identify factors associated with futility. We performed a subgroup analysis on patients who received neoadjuvant systemic therapy. RESULTS: Data from 66 326 patients were analyzed, and 16 772 (25.3%) underwent PD that met criteria for futility. Macroscopically positive margins (odds ratio [OR]: 2.87; 95% confidence interval [CI]: 2.36-3.48), poor tumor differentiation (OR: 2.44; 95% CI: 2.25-2.65), and N2 nodal stage (OR: 2.09; 95% CI: 1.98-2.20) were associated with the greatest odds of futility. Meanwhile, receipt of any systemic therapy (OR: 0.33; 95% CI: 0.31-0.34), receipt of any radiation (OR: 0.60; 95% CI: 0.57-0.63), and receipt of neoadjuvant systemic therapy (OR: 0.62; 95% CI: 0.57-0.66) were associated with the lowest odds of futility. In the neoadjuvant subgroup, a longer diagnosis-to-surgery interval was associated with lower odds of futility. CONCLUSION: PD was futile in about one quarter of patients. Futility was associated with higher age and worse tumor biology. Receipt of neoadjuvant therapy resulted in fewer futile operations.

Association of Neighborhood Disadvantage with Short- and Long-Term Outcomes After Pancreatectomy for Pancreatic Ductal Adenocarcinoma.

BACKGROUND: While lower socioeconomic status has been shown to correlate with worse outcomes in cancer care, data correlating neighborhood-level metrics with outcomes are scarce. We aim to explore the association between neighborhood disadvantage and both short- and long-term postoperative outcomes in patients undergoing pancreatectomy for pancreatic ductal adenocarcinoma (PDAC). PATIENTS AND METHODS: We retrospectively analyzed 243 patients who underwent resection for PDAC at a single institution between 1 January 2010 and 15 September 2021. To measure neighborhood disadvantage, the cohort was divided into tertiles by Area Deprivation Index (ADI). Short-term outcomes of interest were minor complications, major complications, unplanned readmission within 30 days, prolonged hospitalization, and delayed gastric emptying (DGE). The long-term outcome of interest was overall survival. Logistic regression was used to test short-term outcomes; Cox proportional hazards models and Kaplan-Meier method were used for long-term outcomes. RESULTS: The median ADI of the cohort was 49 (IQR 32-64.5). On adjusted analysis, the high-ADI group demonstrated greater odds of suffering a major complication (odds ratio [OR], 2.78; 95% confidence interval [CI], 1.26-6.40; p = 0.01) and of an unplanned readmission (OR, 3.09; 95% CI, 1.16-9.28; p = 0.03) compared with the low-ADI group. There were no significant differences between groups in the odds of minor complications, prolonged hospitalization, or DGE (all p > 0.05). High ADI did not confer an increased hazard of death (p = 0.63). CONCLUSIONS: We found that worse neighborhood disadvantage is associated with a higher risk of major complication and unplanned readmission after pancreatectomy for PDAC.

Association Between Biliary Pathogens, Surgical Site Infection, and Pancreatic Fistula: Results of a Randomized Trial of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy.

OBJECTIVE: To establish the association between bactibilia and postoperative complications when stratified by perioperative antibiotic prophylaxis. BACKGROUND: Patients undergoing pancreatoduodenectomy experience high rates of surgical site infection (SSI) and clinically relevant postoperative pancreatic fistula (CR-POPF). Contaminated bile is known to be associated with SSI, but the role of antibiotic prophylaxis in mitigation of infectious risks is ill-defined. METHODS: Intraoperative bile cultures (IOBCs) were collected as an adjunct to a randomized phase 3 clinical trial comparing piperacillin-tazobactam with cefoxitin as perioperative prophylaxis in patients undergoing pancreatoduodenectomy. After compilation of IOBC data, associations between culture results, SSI, and CR-POPF were assessed using logistic regression stratified by the presence of a preoperative biliary stent. RESULTS: Of 778 participants in the clinical trial, IOBC were available for 247 participants. Overall, 68 (27.5%) grew no organisms, 37 (15.0%) grew 1 organism, and 142 (57.5%) were polymicrobial. Organisms resistant to cefoxitin but not piperacillin-tazobactam were present in 95 patients (45.2%). The presence of cefoxitin-resistant organisms, 92.6% of which contained either Enterobacter spp. or Enterococcus spp., was associated with the development of SSI in participants treated with cefoxitin [53.5% vs 25.0%; odds ratio (OR)=3.44, 95% CI: 1.50-7.91; P =0.004] but not those treated with piperacillin-tazobactam (13.5% vs 27.0%; OR=0.42, 95% CI: 0.14-1.29; P =0.128). Similarly, cefoxitin-resistant organisms were associated with CR-POPF in participants treated with cefoxitin (24.1% vs 5.8%; OR=3.45, 95% CI: 1.22-9.74; P =0.017) but not those treated with piperacillin-tazobactam (5.4% vs 4.8%; OR=0.92, 95% CI: 0.30-2.80; P =0.888). CONCLUSIONS: Previously observed reductions in SSI and CR-POPF in patients that received piperacillin-tazobactam antibiotic prophylaxis are potentially mediated by biliary pathogens that are cefoxitin resistant, specifically Enterobacter spp. and Enterococcus spp.

Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial.

Importance: Despite improvements in perioperative mortality, the incidence of postoperative surgical site infection (SSI) remains high after pancreatoduodenectomy. The effect of broad-spectrum antimicrobial surgical prophylaxis in reducing SSI is poorly understood. Objective: To define the effect of broad-spectrum perioperative antimicrobial prophylaxis on postoperative SSI incidence compared with standard care antibiotics. Design, Setting, and Participants: Pragmatic, open-label, multicenter, randomized phase 3 clinical trial at 26 hospitals across the US and Canada. Participants were enrolled between November 2017 and August 2021, with follow-up through December 2021. Adults undergoing open pancreatoduodenectomy for any indication were eligible. Individuals were excluded if they had allergies to study medications, active infections, chronic steroid use, significant kidney dysfunction, or were pregnant or breastfeeding. Participants were block randomized in a 1:1 ratio and stratified by the presence of a preoperative biliary stent. Participants, investigators, and statisticians analyzing trial data were unblinded to treatment assignment. Intervention: The intervention group received piperacillin-tazobactam (3.375 or 4 g intravenously) as perioperative antimicrobial prophylaxis, while the control group received cefoxitin (2 g intravenously; standard care). Main Outcomes and Measures: The primary outcome was development of postoperative SSI within 30 days. Secondary end points included 30-day mortality, development of clinically relevant postoperative pancreatic fistula, and sepsis. All data were collected as part of the American College of Surgeons National Surgical Quality Improvement Program. Results: The trial was terminated at an interim analysis on the basis of a predefined stopping rule. Of 778 participants (378 in the piperacillin-tazobactam group [median age, 66.8 y; 233 {61.6%} men] and 400 in the cefoxitin group [median age, 68.0 y; 223 {55.8%} men]), the percentage with SSI at 30 days was lower in the perioperative piperacillin-tazobactam vs cefoxitin group (19.8% vs 32.8%; absolute difference, -13.0% [95% CI, -19.1% to -6.9%]; P < .001). Participants treated with piperacillin-tazobactam, vs cefoxitin, had lower rates of postoperative sepsis (4.2% vs 7.5%; difference, -3.3% [95% CI, -6.6% to 0.0%]; P = .02) and clinically relevant postoperative pancreatic fistula (12.7% vs 19.0%; difference, -6.3% [95% CI, -11.4% to -1.2%]; P = .03). Mortality rates at 30 days were 1.3% (5/378) among participants treated with piperacillin-tazobactam and 2.5% (10/400) among those receiving cefoxitin (difference, -1.2% [95% CI, -3.1% to 0.7%]; P = .32). Conclusions and Relevance: In participants undergoing open pancreatoduodenectomy, use of piperacillin-tazobactam as perioperative prophylaxis reduced postoperative SSI, pancreatic fistula, and multiple downstream sequelae of SSI. The findings support the use of piperacillin-tazobactam as standard care for open pancreatoduodenectomy. Trial Registration: ClinicalTrials.gov Identifier: NCT03269994.

Impact of Preoperative Jaundice and Biliary Drainage on Short- and Long-term Outcomes among Patients with Gallbladder Cancer.

OBJECTIVES: To characterize the prognostic implication of jaundice and preoperative biliary drainage on postoperative outcomes among patients with gallbladder cancer (GBC) undergoing surgical resection. METHODS: Patients who underwent surgical resection of GBC identified from a multicenter database between January 2000 and December 2019 were retrospectively analyzed. Data on clinical and pathological details, as well as short- and long-term overall survival (OS), were obtained and compared among patients with and without preoperative jaundice and biliary drainage. RESULTS: Among 449 patients with GBC, median and 1-, 3-, and 5-year OS were 17.4 months, 63.7%, 28.4%, and 22.1%, respectively. Patients who presented with preoperative jaundice (n = 100, 22.3%) were more likely to have advanced disease, a lower incidence of R0 resection (29.0% vs. 69.1%, p < 0.001), as well as a higher incidence of postoperative liver failure (4% vs. 0, p = 0.002), and worse long-term survival versus patients without jaundice (median OS, 10.4 vs. 27.1 months, p < 0.001). Preoperative biliary drainage was performed for the majority of jaundiced patients (77.0%) and was associated with decreased risk of postoperative liver failure (1.3% vs. 13.0%, p = 0.041); preoperative biliary drainage failed to improve long-term survival (median OS, 10.2 months vs. 12.0 months, p = 0.679). On multivariable analysis, R0 resection (17.5 vs. 7.6 months, p < 0.001) and adjuvant therapy (15.6 vs. 6.6 months, p = 0.027) were associated with improved long-term survival among jaundiced patients. CONCLUSIONS: While preoperative biliary drainage of jaundiced GBC patients decreased the risk of postoperative liver failure, it did not impact long-term outcomes. Rather, preoperative jaundice was associated with a lower chance at R0 resection and worse long-term survival.

Impact of adjuvant therapy on outcomes after curative-intent resection for distal cholangiocarcinoma.

BACKGROUND: The benefit of adjuvant therapy (AT) after curative resection of distal cholangiocarcinoma (DCC) remains unclear. The objective of the current study was to investigate the impact of AT on long-term survival of patients who underwent curative-intent resection for DCC. METHODS: Patients who underwent curative-intent resection for DCC between 2000 and 2020 were identified from a multi-institutional database. The primary outcomes included overall (OS) and recurrence-free survival (RFS). RESULTS: Among 245 patients, 150 (61.2%) patients received AT (chemotherapy alone: n = 43; chemo- and radiotherapy: n = 107) after surgical resection, whereas 95 (38.8%) patients underwent surgery only. Patients who received AT were younger, and more likely to have an advanced tumor with the presence of perineural invasion (PNI), lymph node metastasis (LNM), lymph-vascular invasion, and higher T categories (all p < 0.05). Overall, there was no difference in OS (median, surgery + AT 25.5 vs. surgery alone 24.5 months, p = 0.27) or RFS (median, surgery + AT 15.8 vs. surgery alone 18.9 months, p = 0.24) among patients who did versus did not receive AT. In contrast, AT was associated with improved long-term survival among patients with PNI (median OS, surgery + AT 25.9 vs. surgery alone 17.8 months, p = 0.03; median RFS, surgery + AT 15.9 vs. surgery alone 11.9 months, p = 0.04) and LNM (median, surgery + AT 20.0 vs. surgery alone 17.8 months, p = 0.03), but not among patients with no PNI or LNM (all p > 0.1). CONCLUSIONS: AT was commonly utilized among patients with DCC. Patients with more advanced disease, including the presence of PNI or LNM, benefited the most from AT with improved long-term outcomes among this subset of patients.

Very Early Recurrence After Curative-Intent Surgery for Gastric Adenocarcinoma.

BACKGROUND: Recurrence after curative-intent surgery can occur in more than 50% of gastric cancer (GC) patients. We sought to identify predictors of very early recurrence (VER) among GC patients who underwent curative-intent surgery. METHODS: A multi-institutional database of GC patients undergoing curative-intent surgery between 2000 and 2020 at 8 major institutions was queried. VER was defined as local or distant tumor recurrence within 6 months from surgery. Univariable Cox proportional hazard models were used to evaluate the predictive value of clinical-pathological features on VER. A regularized Cox regression model was employed to build a predictive model of VER and recurrence within 12 months. The discriminant ability of the Cox regularized models was evaluated by reporting a ROC curve together with the calibration plot, considering 200 runs. RESULTS: Among 1133 patients, 65 (16.0%) patients experienced a VER. Preoperative symptoms (HR 1.198), comorbidities (HR 1.289), tumor grade (HR 1.043), LNR (HR 4.339) and T stage (HR 1.639) were associated with an increased likelihood of VER. Model performance was very good at predicting VER at 6 months (AUC of 0.722) and 12 months (AUC 0.733). Two nomograms to predict 6-month and 12-month VER were built based on the predictive model. A higher nomogram score was associated with worse prognosis. There was good prediction between observed and estimated VER with minimal evidence of overfitting and good performance on internal bootstrapping validation. CONCLUSION: One in 6 patients experienced VER following curative-intent surgery for GC. Nomograms to predict risk of VER performed well on internal validation, and stratified patients into distinct prognostic groups relative to 6- and 12-months recurrence.

Using machine learning to preoperatively stratify prognosis among patients with gallbladder cancer: a multi-institutional analysis.

BACKGROUND: Gallbladder cancer (GBC) is an aggressive malignancy associated with a high risk of recurrence and mortality. We used a machine-based learning approach to stratify patients into distinct prognostic groups using preperative variables. METHODS: Patients undergoing curative-intent resection of GBC were identified using a multi-institutional database. A classification and regression tree (CART) was used to stratify patients relative to overall survival (OS) based on preoperative clinical factors. RESULTS: CART analysis identified tumor size, biliary drainage, carbohydrate antigen 19-9 (CA19-9) levels, and neutrophil-lymphocyte ratio (NLR) as the factors most strongly associated with OS. Machine learning cohorted patients into four prognostic groups: Group 1 (n = 109): NLR ≤1.5, CA19-9 ≤20, no drainage, tumor size <5.0 cm; Group 2 (n = 88): NLR >1.5, CA19-9 ≤20, no drainage, tumor size <5.0 cm; Group 3 (n = 46): CA19-9 >20, no drainage, tumor size <5.0 cm; Group 4 (n = 77): tumor size <5.0 cm with drainage OR tumor size ≥5.0 cm. Median OS decreased incrementally with CART group designation (59.5, 27.6, 20.6, and 12.1 months; p < 0.0001). CONCLUSIONS: A machine-based model was able to stratify GBC patients into four distinct prognostic groups based only on preoperative characteristics. Characterizing patient prognosis with machine learning tools may help physicians provide more patient-centered care.

Treatment Inequity: Examining the Influence of Non-Hispanic Black Race and Ethnicity on Pancreatic Cancer Care and Survival in Wisconsin.

INTRODUCTION: We investigated race and ethnicity-based disparities in first course treatment and overall survival among Wisconsin pancreatic cancer patients. METHODS: We identified adults diagnosed with pancreatic adenocarcinoma in the Wisconsin Cancer Reporting System from 2004 through 2017. We assessed race and ethnicity-based disparities in first course of treatment via adjusted logistic regression and overall survival via 4 incremental Cox proportional hazards regression models. RESULTS: The study included 8,490 patients: 91.3% (n = 7,755) non-Hispanic White; 5.1% (n = 437) non-Hispanic Black, 1.8% (n = 151) Hispanic, 0.6% Native American (n = 53), and 0.6% Asian (n = 51) race and ethnicities. Non-Hispanic Black patients had lower odds of treatment than non-Hispanic White patients for full patient (OR, 0.52; 95% CI, 0.41-0.65) and Medicare cohorts (OR, 0.40; 95% CI, 0.29-0.55). Non-Hispanic Black patients had lower odds of receiving surgery than non-Hispanic White patients (full cohort OR, 0.67 [95% CI, 0.48-0.92]; Medicare cohort OR, 0.57 [95% CI, 0.34-0.93]). Non-Hispanic Black patients experienced worse survival than non-Hispanic White patients in the first 2 incremental Cox proportional hazard regression models (model II HR, 1.18; 95% CI, 1.06-1.31). After adding insurance and treatment course, non-Hispanic Black and non-Hispanic White patients experienced similar survival (HR, 0.98; 95% CI, 0.88-1.09). CONCLUSION: Non-Hispanic Black patients were almost 50% less likely to receive any treatment and 33% less likely to receive surgery than non-Hispanic White patients. After including treatment course, non-Hispanic Black and non-Hispanic White patient survival was similar. Increasing non-Hispanic Black patient treatment rates by addressing structural factors affecting treatment availability and employing culturally humble approaches to treatment discussions may mitigate these disparities.

Rethinking Routine Intensive Care After Cytoreductive Surgery With Heated Intraperitoneal Chemotherapy: The Fiscal Argument.

BACKGROUND: Patients undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) are frequently admitted to the intensive care unit (ICU) for mitigation of potential complications, although ICU length of stay (LOS) is a significant driver of cost. This study asked whether a fiscal argument could be made for the selective avoidance of ICU admission after CRS/HIPEC. METHODS: Prospective data for select low-risk patients (e.g., lower peritoneal cancer index [PCI]) admitted to the intermediate care unit (IMC) instead of the ICU after CRS/HIPEC were matched with a historic cohort routinely admitted to the ICU. Cohort comparisons and the impact of the intervention on cost were assessed. RESULTS: The study matched 81 CRS/HIPEC procedures to form a cohort of 49 pre- and 15 post-intervention procedures for patients with similar disease burdens (mean PCI, 8 ± 6.7 vs. 7 ± 5.1). The pre-intervention patients stayed a median of 1 day longer in the ICU (1 day [IQR, 1-1 day] vs. 0 days [IQR, 0-0 days]) and had a longer LOS (8 days [IQR, 7-11 days] vs. 6 days [IQR, 5.5-9 days]). Complications and complication severity did not differ statistically. The median total hospital cost was lower after intervention ($30,845 [IQR, $30,181-$37,725] vs. $41,477 [IQR, $33,303-$51,838]), driven by decreased indirect fixed cost ($8984 [IQR, $8643-$11,286] vs. $14,314 [IQR, $12,206-$18,266]). In a weighted multiple variable linear regression analysis, the intervention was associated with a savings of $2208.68 per patient. CONCLUSIONS: Selective admission to the IMC after CRS/HIPEC was associated with $2208.68 in savings per patient without added risk. In this era of cost-conscious practice of medicine, these data highlight an opportunity to decrease cost by more than 5% for patients undergoing CRS/HIPEC.

Incidence of Second Primary Melanoma in Cutaneous Melanoma Survivors.

BACKGROUND: Cutaneous melanoma survivors are at increased risk of a second primary melanoma. Valid estimates facilitate counseling on recommended surveillance after a melanoma diagnosis. However, most estimates of 5- and 10-year incidences of second melanomas are from older cohorts and/or single institutions. This study aimed to determine the 5- and 10-year incidences of second primary cutaneous melanomas in survivors of cutaneous melanoma. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was used to identify cases of non-metastatic, first cutaneous melanoma diagnosed between 1998 and 2012 (follow-up through December 2017). Eligible survivors were 18 years old or older who underwent surgery as a treatment component. Kaplan-Meier survival analysis was used to estimate 5- and 10-year incidences of a second melanoma, excluding new diagnoses within 3 months after the initial diagnosis. Patients were censored at second melanoma diagnosis, death, or 10-years, whichever was first. Multivariable Cox regression analysis was used to identify factors associated with a second cutaneous melanoma diagnosis. RESULTS: The study cohort comprised 152,811 patients. The incidence of second primary melanoma was 3.9% at 5 years (95% confidence interval [CI], 3.8-4.0%) and 6.7% at 10 years (95% CI, 6.6-6.9%). Older age, male sex, and regional disease were associated with increased risk of a second primary melanoma diagnosis. CONCLUSION: Melanoma survivors are at risk of a second primary melanoma, making routine skin surveillance part of recommended follow-up evaluation. A higher incidence of second melanoma with older age and regional disease at presentation is possibly explained by increased health care use providing more diagnostic opportunities, whereas male sex may represent an inherent risk factor.

Promoting patient engagement during care transitions after surgery using mobile technology: Lessons learned from the MobiMD pilot study.

BACKGROUND: Poorly coordinated transitions of care in complex abdominal surgery patients contribute to frequent hospital readmissions and inflated healthcare spending. Mobile health (mHealth) transitional care technologies may reduce surgical readmissions yet remain understudied in high-risk surgical populations. METHODS: We conducted a single-group, prepost study of a mHealth transitional care app in 50 complex surgical patients. Eligible patients were adults undergoing complex abdominal surgery in the divisions of Surgical Oncology and Colorectal Surgery. The main outcome was app engagement, calculated by notification response rate (number of participant-entered datapoints divided by the total number of app-requested datapoints) over the 30-day postoperative period. Secondary outcomes included changes in engagement over time and by individual app feature. RESULTS: A total of 85% (50/59) of eligible patients enrolled. Most participants were male (58%, n = 29), and mean age was 50 years (range 24-80 years). Overall notification response rate was 28%. Among the 58% of participants (29/50) who engaged with the app at least once after discharge (app users), the average notification response rate was 45%. The mean notification response rate among app users decreased over time from 50% to 32% between weeks 1 and 4 after hospital discharge. Engagement with individual app features ranged from 48-81%, with highest engagement for symptom reports and lowest engagement for wound care instructions. CONCLUSION: mHealth transitional care is feasible in complex surgical patients using only patients' existing smart devices. Randomized controlled trials are required to determine the impact on hospital readmissions, surgical outcomes, patient satisfaction, and overall resource utilization.

Does the Volume-Outcome Association in Pancreas Cancer Surgery Justify Regionalization of Care? A Review of Current Controversies.

INTRODUCTION: Increasing hospital or surgeon volume is associated with improved outcomes among patients with pancreatic cancer. Promotion of regionalized care is based on this volume-outcome association. However, other research has exposed nuances and complexities inherent to this association that should be considered when promoting regionalized care models. We herein provide a critical review of the literature on the volume-outcome association and a discussion of areas of ongoing controversy. METHODS: A PubMed literature search was conducted for the years 1995-2020. Peer reviewed original research studies were selected for critical review based on study design, potential to draw meaningful conclusions from the data, and discussion of current knowledge gaps. RESULTS: Based on the cumulative published literature, hospital/surgeon volume and patient mortality are inversely related. However, it remains unclear whether volume is a proxy for other more causative variables inherent in high-volume centers. Interpretation of the volume-outcome association is made more difficult to interpret due to the large variation in the definition of high volume, difficulty in isolating the individual impact of surgeon versus hospital volume, challenges in quantifying health system processes related to volume, and the fact that some low-volume centers consistently achieve excellent clinical results. Implementation of true regionalized care models has been rare, likely reflecting both health system and patient level challenges. CONCLUSION: The volume-outcome association has been consistently demonstrated to be important to the care of patients with pancreas cancer. The underlying mechanism of this association to explain the overall benefit is likely multifactorial. Better understanding of what drives the volume-outcome association may increase access to optimized care for a broader range of hospital systems and patients.

Development of a Prognostic Nomogram and Nomogram Software Application Tool to Predict Overall Survival and Disease-Free Survival After Curative-Intent Gastrectomy for Gastric Cancer.

BACKGROUND: We sought to derive and validate a prediction model of survival and recurrence among Western patients undergoing resection of gastric cancer. METHODS: Patients who underwent curative-intent surgery for gastric cancer at seven US institutions and a major Italian center from 2000 to 2020 were included. Variables included in the multivariable Cox models were identified using an automated model selection procedure based on an algorithm. Best models were selected using the Bayesian information criterion (BIC). The performance of the models was internally cross-validated via the bootstrap resampling procedure. Discrimination was evaluated using the Harrell's Concordance Index and accuracy was evaluated using calibration plots. Nomograms were made available as online tools. RESULTS: Overall, 895 patients met inclusion criteria. Age (hazard ratio [HR] 1.47, 95% confidence interval [CI] 1.17-1.84), presence of preoperative comorbidities (HR 1.66, 95% CI 1.14-2.41), lymph node ratio (LNR; HR 1.72, 95% CI 1.42-2.01), and lymphovascular invasion (HR 1.81, 95% CI 1.33-2.45) were associated with overall survival (OS; all p < 0.01), whereas tumor location (HR 1.93, 95% CI 1.23-3.02), T category (Tis-T1 vs. T3: HR 0.31, 95% CI 0.14-0.66), LNR (HR 1.82, 95% CI 1.45-2.28), and lymphovascular invasion (HR 1.49; 95% CI 1.01-2.22) were associated with disease-free survival (DFS; all p < 0.05) The models demonstrated good discrimination on internal validation relative to OS (C-index 0.70) and DFS (C-index 0.74). CONCLUSIONS: A web-based nomograms to predict OS and DFS among gastric cancer patients following resection demonstrated good accuracy and discrimination and good performance on internal validation.

Surgical treatment of gastric adenocarcinoma: Are we achieving textbook oncologic outcomes for our patients?

BACKGROUND AND OBJECTIVES: Composite measures are increasingly used to assess quality of care in surgical oncology. We sought to define the incidence of "textbook oncologic outcome" (TOO) following resection of gastric adenocarcinoma among a large, international cohort of patients. METHODS: Gastric adenocarcinoma patients undergoing resection between 2000 and 2020 were identified from an international database. TOO was defined as margin-negative resection, examination of ≥16 lymph nodes, no prolonged length-of-stay (LOS), no 30-day mortality, and stage-appropriate receipt of chemotherapy. RESULTS: Among a total of 910 patients, 321 patients (35.3%) achieved a postoperative TOO. While failure to evaluate ≥16 lymph nodes (n = 591, 65.0%) and receipt of chemotherapy (n = 651, 71.5%) had the greatest negative impact on the ability to obtain a TOO, no 30-day mortality (n = 880, 96.7%), margin-negative resection (n = 831, 91.3%), and no extended LOS (n = 706, 77.6%) were more commonly achieved. No postoperative complications (OR: 0.44; 95% CI: 0.31-0.63) and T1a/T1b-stage disease (OR: 2.87; 95% CI: 1.59-5.18) were independently associated with achieving a TOO (p < 0.05). The odds of achieving a TOO improved over time (p-trend < 0.05), which was largely attributable to improved odds of evaluating ≥16 lymph nodes (2010-2014 vs. 2000-2004: OR, 5.21; 95% CI: 3.22-8.45). CONCLUSIONS: Only about one in three patients achieved a TOO following resection of gastric adenocarcinoma. Odds of TOO increased over time, largely due to improved lymph node evaluation.

Protocol for the MobiMD trial: A randomized controlled trial to evaluate the effect of a self-monitoring mobile app on hospital readmissions for complex surgical patients.

BACKGROUND: Hospital readmissions are estimated to cost $17.4 billion per year in the Medicare population alone, with readmission rates as high as 30% for patients undergoing complex abdominal surgery. Improved transitional care and self-monitoring may reduce preventable readmissions for such high-risk populations. In this study, we will conduct a single-institution randomized controlled trial (RCT) to assess the effect of a novel transitional care mobile app, MobiMD, on hospital readmission in complex abdominal surgery patients. METHODS: Three hundred patients will be randomized 1:1 to standard of care (SOC) versus SOC plus MobiMD app in a parallel, single-blinded, two-arm RCT. Eligible patients are those who undergo complex abdominal surgery in the division of Surgical Oncology, Colorectal Surgery or Transplant Surgery. The MobiMD app provides push notification reminders directly to the patient's smart device, prompting them to enter clinical data and patient-reported outcomes. Clinical data collected via the MobiMD app include vital signs, red flag symptoms, daily wound and surgical drain images, ostomy output, drain output, medication compliance, and wound care compliance. These data are reviewed daily by a physician. The primary outcome is the proportion of participants readmitted to the hospital within 30 days of surgery. Secondary outcomes are 90-day hospital readmission, emergency department and urgent care visits, complication severity, and total readmission cost. DISCUSSION: If effective, mobile health apps such as MobiMD could be routinely integrated into surgical transitional care programs to minimize unnecessary hospital readmissions, emergency department visits and healthcare resource utilization. Clinical trials identifier: NCT04540315.

Dynamic Prediction of Survival after Curative Resection of Gastric Adenocarcinoma: A landmarking-based analysis.

BACKGROUND: Accurate estimation of survival and recurrence are important to inform decisions regarding therapy and surveillance. We sought to design and validate a dynamic prognostic model for patients undergoing resection for gastric adenocarcinoma. METHODS: Patients who underwent curative-intent surgery for gastric adenocarcinoma between 2000 and 2020 were identified using a multi-institutional database. Landmark analysis was used to create dynamic OS and DFS prediction models. Model performance was internally cross-validated via bootstrap resampling. RESULTS: Among 895 patients, 507 (57.2%) patients underwent partial gastrectomy (n = 507, 57.2%) while 380 (42.8%) had total gastrectomy. Median tumor size was 40 mm (IQR: 25-65), most tumors were located in the antrum (n = 344, 39.5%) and infiltrated the subserosa (T3 tumors: n = 283, 31.9%) or serosa (T4 tumors: n = 253, 28.5%); lymph node metastasis occurred in 528 (59.1%) patients. Median OS and DFS were 17.5 (IQR: 7.5-42.8) and 14.3 months (IQR: 6.5-39.9), respectively. The impact of age, sex, preoperative comorbidities, tumor size and location, extent of lymphadenectomy and total number of lymph nodes examined, Lauren class, T and N category, postoperative complications, and tumor recurrence varied over time (all p < 0.05). An online tool to predict dynamic OS and DFS based on patient survival relative to time survived was developed and made available for clinical use. Discrimination ability of OS and DFS was excellent (C-index: 0.84 and 0.86, respectively) and calibration plots revealed good prediction. CONCLUSIONS: An online dynamic prognostic tool was developed and validated to predict OS and DFS following resection of gastric adenocarcinoma. Landmark analysis to predict long-term outcomes based on follow-up time may be helpful to surgeons and patients.

Microwave ablation for colorectal cancer metastasis to the liver: a single-center retrospective analysis.

BACKGROUND: The purpose of this study is to evaluate the safety and intermediate-term efficacy of percutaneous microwave (MW) ablation for the treatment of colorectal liver metastases (CRLM) at a single institution. METHODS: A retrospective review was performed of all CRLM treated with MW ablation from 3/2011 to 7/2020 (102 tumors; 72 procedures; 57 patients). Mean age was 60 years (range, 36-88) and mean tumor size was 1.8 cm (range, 0.5-5.0 cm). The patient population included 19 patients with extra-hepatic disease. Chemotherapy (pre- and/or post-ablation) was given in 98% of patients. Forty-five sessions were preceded by other focal CRLM treatments including resection, ablation, radiation, and radioembolization. Kaplan-Meier curves were used to estimate local tumor progression-free survival (LTPFS), disease-free survival (DFS), and overall survival (OS) and multivariate analysis (Cox Proportional Hazards model) was used to test predictors of OS. RESULTS: Technical success (complete ablation) was 100% and median follow-up was 42 months (range, 1-112). There was a 4% major complication rate and an overall complication rate of 8%. Local tumor progression (LTP) rate during the entire study period was 4/98 (4%), in which 2 were retreated with MW ablation for a secondary LTP-rate of 2%. LTP-free survival at 1, 3, and 5 years was 93%, 58%, and 39% and median LTP-free survival was 48 months. OS at 1, 3, and 5 years was 96%, 66%, 47% and median OS was 52 months. There were no statistically significant predictors of OS. CONCLUSIONS: MW ablation of hepatic colorectal liver metastases appears safe with excellent local tumor control and prolonged survival compared to historical controls in selected patients. Further comparative studies with other local treatment strategies appear indicated.