Objective: Analyzing textbook outcome (TO) following rectal cancer resection and its association with long-term survival when compared to hospital case volume alone. Background: TO is a quality metric representing the ideal result following complex cancer surgery. Prior studies have suggested improved long-term survival for rectal cancer patients undergoing surgery at HV institutions. Methods: Patients undergoing surgery for rectal adenocarcinoma from 2014 to 2015 were identified using the National Cancer Database. Low (LV), medium (MV), and high-volume (HV) hospital strata were defined by quartile cutoffs (low <25th, high >75th, and 25–75th medium volume). TO was achieved with adequate lymph node count (≥12), negative margins (R0 resection), length of stay <75th percentile, absence of 30-day readmission/mortality event, and appropriate plus timely systemic therapy. Adjusted analyses for long-term survival were performed using a hierarchical multivariable Cox regression model. Results: TO was achieved in 28.5% of 48,484 patients. LV or MV hospital patients were more likely to be older, uninsured/Medicaid, and less likely to achieve a TO (HV 31.2% vs MV 29.6% vs LV 23.2%, P < 0.001). TO was associated with improved 5-year survival (84.0% vs 72.0%, P < 0.001). On multivariable analyses, TO was the strongest protective factor against mortality (HR 0.60, 95% confidence interval = 0.56–0.64), even after controlling for case volume. Conclusions: Only 28.5% of patients undergoing resection for rectal cancer achieve TO. However, they had a 40% reduction in long-term mortality independent of hospital volume. Optimizing long-term survival in patients with rectal cancer can be achieved by TO criteria rather than increasing surgical case volume.
Pathologic Complete Response and Survival in Rectal Cancer
Importance Pathologic complete response (pCR) is increasingly used as a surrogate end point for survival in randomized clinical trials (RCTs) in the field of gastrointestinal oncology. Although this approach has been endorsed by the US Food and Drug Administration, it is still novel and incompletely verified. Objective To evaluate the trial-level association between pCR and survival in rectal cancer RCTs examining the effectiveness of neoadjuvant therapy. Data Sources A meta-analysis was conducted to identify eligible RCTs in PubMed, EMBASE, and Cochrane databases published between database inception to January 3, 2024. Study Selection RCTs evaluating neoadjuvant therapies in patients with rectal cancer who underwent subsequent surgical resection and reported pCR, overall survival (OS), and disease-free survival (DFS) were included. Data Extraction and Synthesis Two investigators extracted the data, which were verified by a third author. The risk of bias and the certainty of the evidence were evaluated using the Cochrane Risk of Bias Tool, version 2, and the Grading of Recommendations Assessment, Development, and Evaluation tool, respectively. Adjusted odds and hazard ratios with their 95% CIs were extracted. Weighted linear regression was used to assess the correlation between pCR and both OS and DFS. Main Outcomes and Measures Trial-level correlation between pCR and both OS and DFS. Results Twenty-five RCTs, including 11 882 patients, met the inclusion criteria. On meta-regression analysis, pCR was not correlated with OS (β = 0.37; 95% CI, −0.98 to 1.71; P = .57). Similarly, pCR was not correlated with DFS (β = −0.84; 95% CI, −2.55 to 0.87; P = .32). Two studies (8%) used in the meta-analysis had high risk of bias. On sensitivity analysis excluding these studies, pCR was still not associated with OS or DFS. Subgroup analysis of RCTs using total neoadjuvant therapies was not possible due to limited sample size. Conclusions and Relevance In this systematic review and meta-analysis of RCTs comparing neoadjuvant therapies in rectal cancer, there was no trial-level association between pCR and survival. These results suggest that the use of pCR as a surrogate end point for survival should be reexamined and used more cautiously.
A 10-Year Real-world Assessment of Longitudinal Outcomes Following Bailout Procedures for Severe Cholecystitis
Objective: We comparatively analyzed the longitudinal outcomes of conversion to open procedure, laparoscopic subtotal cholecystectomy (CCY), and laparoscopic cholecystostomy tube placement. Background: Severe cholecystitis often causes dense inflammation that distorts the hepatocystic anatomy and can make safe dissection during CCY challenging. However, controversy exists regarding the optimal bailout procedure in such situations. Methods: The New York and Florida State all-claims databases were queried for patients who underwent laparoscopic CCY for acute cholecystitis from 2012 to 2021. Hierarchical logistic regression models were used to obtain adjusted estimates, with fixed effects assigned to patient-level variables and random effects assigned to hospital identifiers to adjust for intraclass correlation. Results: Of 384,948 laparoscopic CCYs performed, 5448 (1.4%) were not completed laparoscopically; 1370 underwent conversion to open procedure, 2646 underwent laparoscopic subtotal CCY, and 1432 underwent laparoscopic cholecystostomy tube placement. The conversion to open rate decreased from 0.6% in 2012 to 0.3% in 2021, while the laparoscopic subtotal CCY rate increased from 0.2% in 2012 to 1.4% in 2021. The 1-year bile duct injury (BDI) rate was highest for the conversion to open group (4.4%), followed by the laparoscopic subtotal CCY (0.8%) and laparoscopic cholecystostomy tube groups (0.3%, P<0.001). On adjusted analyses with the conversion to open group as the control, laparoscopic subtotal CCY (OR: 0.17, P<0.001) and laparoscopic cholecystostomy tube were associated with lower BDI rates (OR: 0.08, P<0.001, Figure). The 1-year postoperative endoscopic biliary intervention rate was lowest for the conversion to open group (4.2%), followed by the laparoscopic subtotal CCY (8.4%) and the laparoscopic cholecystostomy tube groups (8.8%, P<0.001). The completion CCY rates for the laparoscopic subtotal CCY and laparoscopic cholecystostomy tube groups were 2.1% and 23.4%, respectively. Among completion CCYs, the open rates were 56.4% in the laparoscopic subtotal CCY group versus 24.5% in the laparoscopic cholecystostomy tube group (P<0.001). Conclusions: In patients with severe cholecystitis requiring a bailout procedure, the BDI rate was highest after conversion to open procedure. Laparoscopic subtotal CCY and laparoscopic cholecystostomy tube were associated with lower BDI rates at the cost of higher postoperative endoscopic biliary intervention rates. Completion CCYs were required in 2.1% and 23.4% of patients who underwent laparoscopic subtotal CCY and laparoscopic cholecystostomy tube placement, respectively, of which the former group’s CCY was more likely to require an open operation.
Invited Commentary: Navigating the Fog: Practical Use of Imaging to Guide HIPEC
The National Cancer Database (NCDB) collects data from approximately 1,500 Commission on Cancer (CoC) facilities and represent 73.7% of newly diagnosed cancers nationwide. The American College of Surgeons Cancer Program developed it first annual report from the NCDB 2021 participant user file reporting new observations and recent trends of cancer diagnoses, patient demographics, and treatments as well as an in-depth report on treatment and outcomes in breast, pancreas, and colon cancers. Of the 1,328,131 cancers diagnosed in 2021 at 1,281 reporting CoC hospitals, one-fifth continue to be female breast cancer. In 2021, the NCDB’s 5 most common adult cancers were breast, prostate, lung, colon, and melanoma and varied by patient sex. Use of neoadjuvant systemic therapy increased in recent years in pancreas, breast, and urinary bladder cancer, although a slight decrease in pancreas and breast cancer was observed in 2021. Breast cancer has high survival rates, especially in lower-stage disease and estrogen receptor-positive/human epidermal growth factor receptor 2-negative disease. There is increase in neoadjuvant systemic therapy use, especially in human epidermal growth factor receptor 2-positive disease and estrogen receptor-negative disease. Colon cancer presents most commonly as stage III or II with a primary in the cecum or ascending colon in 38.9%. The majority are microsatellite instability stable, Kirsten rat sarcoma viral oncogene homologue normal, and CEA positive. Survival is most dependent on stage but also associated with microsatellite instability stability, abnormal Kirsten rat sarcoma viral oncogene homologue, and positive CEA. Pancreatic cancer presents with stage IV disease in nearly half, although an increase in stage I disease is seen. The most common location is pancreatic head. Survival is relatively low and most dependent on stage.
Differential utilization of thyroid lobectomy after the 2015 American Thyroid Association guideline update
Background The 2015 American Thyroid Association (ATA) guidelines added thyroid lobectomy (TL) as the appropriate treatment for low-risk differentiated thyroid cancer (DTC). We aimed to investigate the population-level factors that influence the utilization of TL. Methods The Surveillance, Epidemiology and End Results (SEER) database was queried for all DTC patients fitting low-risk criteria as defined by the ATA. Trends in total thyroidectomy (TT) and TL were identified using a Cochrane–Armitage test. Multivariable logistic regression identified patient and socioeconomic characteristics associated with TL, and difference-in-difference analysis was used to control for secular trends over time. Results A total of 43,526 patients with low-risk DTC were identified in the SEER database; 39,411 pre-2015 and 4115 post-2015. After 2015, TT continued to outnumber TL (76.2% vs 23.8%), although the rate of TL increased significantly (11.6% to 23.8%, P < 0.001). However, difference-in-difference analysis found that age > 55 (OR 1.11, 95% CI 1.01–1.19, P < 0.001) and rurality (OR 1.16, 95% CI 1.05–1.28, P < 0.001) were independently associated with TT. TL was associated with T1 disease (OR 1.11, 95% CI 1.04–1.19, P = 0.001). Conclusion Although the 2015 ATA guideline update led to an increase in TL for low-risk DTC, most patients still underwent TT. Age and neighborhood significantly impact the odds of receiving guideline-appropriate TL for low-risk DTC, especially for T2 disease.
Sex differences in altmetric attention scores and traditional impact metrics of top‐cited general surgery literature: Cracks in the ceiling?
AbstractBackgroundSex disparities have previously been identified in surgical academia. This study examines sex differences in the top‐cited contemporary general surgery articles and compares Altimetric Attention Score (AAS) and other impact metrics between male and female corresponding authors (CAs).MethodsWe conducted a bibliometric analysis of the 100 most cited articles published between 2019 and 2021 in each of the top 10 general surgery journals based on the 2021 Journal Impact Factor. Impact metrics included AAS, citation count, and H‐index of the CA. We used multivariable regression analyses to investigate whether the sex of the CA or first author (FA) was independently associated with AAS and citation count.ResultsAmong 1000 articles, 23.1% had female CAs and 27.4% female FAs. Female CA articles had higher AAS (13.0 [2.0–63.0] vs. 8.0 [1.0–28.5]; p < 0.001) and lower H‐indices (24.0 [11.0–45.0] vs. 31.0 [17.0–50.0]; p = 0.015). Although median citation count did not differ by CA sex, articles with Level 1 evidence and a female CA were cited more often (35.5 [24.0–85.0] vs. 25.0 [16.0 vs. 46.0]; p < 0.05). In multivariable regression, female CA articles had higher AAS (OR: 1.002 [95% CI: 1.001–1.004]) and lower H‐index (OR: 0.987 [95% CI: 0.977–0.997]).ConclusionDespite having similar citation counts, articles authored by female CAs exhibit higher AAS scores compared to those authored by their male counterparts. While it is heartening that research authored by female surgeons achieves significant visibility, it remains to be understood how this translates into academic impact and scholarly recognition.
Contemporary Approaches to the Surgical Management of Pancreatic Neuroendocrine Tumors
The incidence of pancreatic neuroendocrine tumors (PNETs) is on the rise primarily due to the increasing use of cross-sectional imaging. Most of these incidentally detected lesions are non-functional PNETs with a small proportion of lesions being hormone-secreting, functional neoplasms. With recent advances in surgical approaches and systemic therapies, the management of PNETs have undergone a paradigm shift towards a more individualized approach. In this manuscript, we review the histologic classification and diagnostic approaches to both functional and non-functional PNETs. Additionally, we detail multidisciplinary approaches and surgical considerations tailored to the tumor’s biology, location, and functionality based on recent evidence. We also discuss the complexities of metastatic disease, exploring liver-directed therapies and the evolving landscape of minimally invasive surgical techniques.
Distinguishing Clinical From Statistical Significances in Contemporary Comparative Effectiveness Research
Objective: To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER). Background: In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity. Methods: CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the “Methods.” Results: Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = −0.30, P = 0.038). Conclusions: In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.
ImportanceCancer is one of the leading causes of death in the United States, with the obesity epidemic contributing to its steady increase every year. Recent cohort studies find an association between bariatric surgery and reduced longitudinal cancer risk, but with heterogeneous findings.ObservationsThis review summarizes how obesity leads to an increased risk of developing cancer and synthesizes current evidence behind the potential for bariatric surgery to reduce longitudinal cancer risk. Overall, bariatric surgery appears to have the strongest and most consistent association with decreased incidence of developing breast, ovarian, and endometrial cancers. The association of bariatric surgery and the development of esophageal, gastric, liver, and pancreas cancer is heterogenous with studies showing either no association or decreased longitudinal incidences. Conversely, there have been preclinical and cohort studies implying an increased risk of developing colon and rectal cancer after bariatric surgery. A review and synthesis of the existing literature reveals epidemiologic shortcomings of cohort studies that potentially explain incongruencies observed between studies.Conclusions and RelevanceStudies examining the association of bariatric surgery and longitudinal cancer risk remain heterogeneous and could be explained by certain epidemiologic considerations. This review provides a framework to better define subgroups of patients at higher risk of developing cancer who would potentially benefit more from bariatric surgery, as well as subgroups where more caution should be exercised.