Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

Circulating Hybrid Cells: A Novel Liquid Biomarker of Treatment Response in Gastrointestinal Cancers.

BACKGROUND: Real-time monitoring of treatment response with a liquid biomarker has potential to inform treatment decisions for patients with rectal adenocarcinoma (RAC), esophageal adenocarcinoma (EAC), and colorectal liver metastasis (CRLM). Circulating hybrid cells (CHCs), which have both immune and tumor cell phenotypes, are detectable in the peripheral blood of patients with gastrointestinal cancers, but their potential as an indicator of treatment response is unexplored. METHODS: Peripheral blood specimens were collected from RAC and EAC patients after neoadjuvant therapy (NAT) or longitudinally during therapy and evaluated for CHC levels by immunostaining. Receiver operating characteristics (ROCs) and the Kaplan-Meier method were used to analyze the CHC level as a predictor of pathologic response to NAT and disease-specific survival (DSS), respectively. RESULTS: Patients with RAC (n = 23) and EAC (n = 34) were sampled on the day of resection, and 11 patients (32%) demonstrated a pathologic complete response (pCR) to NAT. On ROC analysis, CHC levels successfully discriminated pCR from non-pCR with an area under the curve of 0.82 (95% confidence interval [CI], 0.71-0.92; P < 0.001). Additionally, CHC levels in the EAC patients correlated with residual nodal involvement (P = 0.026) and 1-year DSS (P = 0.029). The patients with RAC who were followed longitudinally during NAT (n = 2) and hepatic arterial infusion therapy for CRLM (n = 2) had CHC levels that decreased with therapy response and increased before clinical evidence of disease progression. CONCLUSION: Circulating hybrid cells are a novel blood-based biomarker with potential for monitoring treatment response and disease progression to help guide decisions for further systemic therapy, definitive resection, and post-therapy surveillance. Additional validation studies of CHCs are warranted.

Operative Shutdown and Recovery: Restructuring Surgical Operations During the SARS-CoV-2 Pandemic.

BACKGROUND: During the 2020 SARS-CoV-2 outbreak in New York City, hospitals canceled elective surgeries to increase capacity for critically ill patients. We present case volume data from our community hospital to demonstrate how this shutdown affected surgical care. METHODS: Between March 16 and June 14, 2020, all elective surgeries were canceled at our institution. All procedures performed during this operating room shutdown (ORS) were logged, as well as those 4 weeks before (PRE) and 4 weeks after (POST) for comparison. RESULTS: A total of 2,475 cases were included in our analysis, with 754 occurring during shutdown. Overall case numbers dropped significantly during ORS and increased during recovery (mean 245.0 ± 28.4 PRE versus 58.0 ± 30.9 ORS versus 186.0±19.4 POST cases/wk, P< 0.001). Emergency cases predominated during ORS (26.4% PRE versus 59.3% ORS versus 31.5% POST, P< 0.001) despite decreasing in frequency (mean 64.5 ± 7.9 PRE versus 34.4 ± 12.1 ORS versus 58.5 ± 4.0 POST cases/wk, P< 0.001). Open surgeries remained constant in all three phases (52.2-54.1%), whereas laparoscopic and robotic surgeries decreased (-3.4% and -3.0%, P< 0.001). General and/or vascular surgery, urology, and neurosurgery comprised a greater proportion of caseload (+9.5%, +3.0%, +2.8%), whereas orthopedics, gynecology, and otolaryngology/plastic surgery all decreased proportionally (-5.0%, -4.4%, -5.9%, P< 0.001). CONCLUSION: Operative volume significantly decreased during the SARS-CoV-2 outbreak. Emergency cases predominated during this time, although there were fewer emergency cases overall. General/vascular surgery became the most active service and open surgeries became more common. This reallocation of resources may be useful for future crisis planning among community hospitals.

Specific Tumor Characteristics Predict Upstaging in Early-Stage Esophageal Cancer.

BACKGROUND: Early-stage esophageal cancer (stages 0-1) has been shown to have relatively good outcomes after local endoscopic or surgical resection. For this reason, neoadjuvant chemoradiation usually is reserved for higher-stage disease. Some early tumors, however, are found after resection to be more advanced than predicted based on initial clinical staging, termed pathologic upstaging. Such tumors may have benefited from alternate treatment models had their true stage been known preoperatively. This study aimed to identify high-risk features in early esophageal cancers that might predict tumor upstaging and guide more individualized treatment algorithms. METHODS: Through retrospective review of a single-institution foregut disease registry, we evaluated patients who underwent esophagectomy for high-grade dysplasia (Tis) or stage 1 esophageal cancer, searching for factors associated with pathologic upstaging. RESULTS: The review included 110 patients (88% male, median age at diagnosis, 64.5 years) treated between January 2000 and June 2016. Upstaging occurred for 20.9% of the patients, and was more common for patients with angiolymphatic invasion (odds ratio [OR], 11.07; 95% confidence interval [CI], 2.96-41.44; P < 0.001) or signet-ring features (OR, 23.9; 95% CI, 2.6-216.8; P = 0.005). In the absence of other predictors, upstaging was associated with decreased overall survival (P = 0.006). CONCLUSIONS: Approximately 20% of patients with early-stage esophageal cancer may be upstaged at resection. Angiolymphatic invasion and signet-ring features may predict tumors likely to be upstaged, resulting in decreased overall survival.

Major Barbara Stimson: A Historical Perspective on the American Board of Surgery Through the Accomplishments of the First Woman to Achieve Board Certification.

: Dr. Barbara Bartlett Stimson, AB, MD, MedScD, FACS (1898-1986) was a pioneering orthopedic surgeon from a prominent American family who, in 1940, became the first woman certified by the American Board of Surgery (ABS, certificate number 860). It would be another 7 years and approximately 2500 candidates before the next female surgeon would be certified. A member of the third class to admit women to Columbia Medical School and the second female surgical resident to complete training at Columbia-Presbyterian Medical Center, Dr. Stimson was a confident and exceptionally accomplished trailblazer for women in surgery. In this biographical sketch based upon documents from the ABS, and the archives of Vassar College and the College of Physicians and Surgeons at Columbia-Presbyterian Medical Center, Dr. Stimson's motivations, attitudes, and unique accomplishments emerge as testimony to the exceptional career of this driven, self-possessed woman. Stimson was undaunted by the sex-based conventions of her time, and achieved a notable career as a surgeon in the profession she loved; first honing her skills at a busy urban fracture service in New York, then serving with distinction in the Royal Army Medical Corps during World War II, and finally returning to the states to become a respected leader in her field. Her life story and unprecedented ABS certification affirm her conviction that proven skill and ability can be used as a means of overcoming unfounded biases, and helped pave the way for future generations of board certified female surgeons in the United States.

Analysis of Gender-based Differences in Surgery Faculty Compensation, Promotion, and Retention: Establishing Equity.

OBJECTIVES: The objectives of this study were to evaluate gender-based differences in faculty salaries before and after implementation of a university-wide objective compensation plan, Faculty First (FF), in alignment with Association of American Medical Colleges regional median salary (AAMC-WRMS). Gender-based differences in promotion and retention were also assessed. SUMMARY BACKGROUND DATA: Previous studies demonstrate that female faculty within surgery are compensated less than male counterparts are and have decreased representation in higher academic ranks and leadership positions. METHODS: At a single institution, surgery faculty salaries and work relative value units (wRVUs) were reviewed from 2009 to 2017, and time to promotion and retention were reviewed from 1998 to 2007. In 2015, FF supplanted specialty-specific compensation plans. Salaries and wRVUs relative to AAMC-WRMS, time to promotion, and retention were compared between genders. RESULTS: Female faculty (N = 24) were compensated significantly less than males were (N = 62) before FF (P = 0.004). Female faculty compensation significantly increased after FF (P < 0.001). After FF, female and male faculty compensation was similar (P = 0.32). Average time to promotion for female (N = 29) and male faculty (N = 82) was similar for promotion to associate professor (P = 0.49) and to full professor (P = 0.37). Promotion was associated with significantly higher retention for both genders (P < 0.001). The median time of departure was similar between female and male faculty (P = 0.73). CONCLUSIONS: A university-wide objective compensation plan increased faculty salaries to the AAMC western region median, allowing correction of gender-based salary inequity. Time to promotion and retention was similar between female and male faculty.

Modern diagnosis and treatment of hiatal hernias.

PURPOSE: Hiatal hernias are a common finding on radiographic or endoscopic studies. Hiatal hernias may become symptomatic or, less frequently, can incarcerate or become a volvulus leading to organ ischemia. This review examines latest evidence on the diagnostic workup and management of hiatal hernias. METHODS: A literature review of contemporary and latest studies with highest quality of evidence was completed. This information was examined and compiled in review format. RESULTS: Asymptomatic hiatal and paraesophageal hernias become symptomatic and necessitate repair at a rate of 1% per year. Watchful waiting is appropriate for asymptomatic hernias. Symptomatic hiatal hernias and those with confirmed reflux disease require operative repair with an anti-reflux procedure. Key operative steps include the following: reduction and excision of hernia sac, 3 cm of intraabdominal esophageal length, crural closure with mesh reinforcement, and an anti-reflux procedure. Repairs not amenable to key steps may undergo gastropexy and gastrostomy placement as an alternative procedure. CONCLUSIONS: Hiatal hernias are commonly incidental findings. When hernias become symptomatic or have reflux disease, an operative repair is required. A minimally invasive approach is safe and has improved outcomes.

Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.

BACKGROUND & AIMS: Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS: We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS: By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS: TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Major bile duct injury requiring operative reconstruction after laparoscopic cholecystectomy: a follow-on study.

BACKGROUND: Bile duct injury (BDI) after laparoscopic cholecystectomy (LC) has significant cost impact and is a significant source of morbidity and mortality. We undertook a population-based assessment of the national experience with BDI between 2001 and 2011 and compared this to our report for the prior decade. METHODS: Using the nationwide inpatient sample (NIS) for 2001-2011, we identified patients who underwent LC or partial cholecystectomy, with and without biliary reconstruction. Data were analyzed using methods that accounted for the hierarchical, stratified random sampling of the NIS. Both univariate modeling and multivariate modeling were performed. RESULTS: LCs increased from 71.1 % in 2001 to 79.0 % in 2011 (p < 0.0001). Annual mortality decreased from 0.56 to 0.38 % (p = 0.002). In 2001, 0.11 % of LCs were associated with biliary reconstruction versus 0.09 % in 2011 (p = 0.15) with rates ranging from 0.08 to 0.12 %. The need for reconstruction was associated with an average in-hospital mortality rate of 4.4 %. Mortality rates from LC remained consistent across the study period (average mortality, 0.10 %, p = 0.57). Under multivariate analysis, admission to rural or urban non-teaching centers was associated with a decreased rate of injury; the majority of major BDIs were admitted from clinic or outpatient settings. These results are consistent with results from the prior decade. Neither emergent admission nor race was associated with increased odds of BDI, and this differs from our prior analysis. CONCLUSION: LC continued to increase in utilization between 2001 and 2011. Although rates of BDI have decreased, the need for reconstruction continues to be associated with a significant mortality. In addition, mortality related to biliary reconstruction is also higher than previously published series and may reflect the complexity of managing biliary injury as well as the higher likelihood of these patients having comorbid conditions.

The Global Burden of Esophageal Cancer: A Disability-Adjusted Life-Year Approach.

INTRODUCTION: Esophageal cancer is the eighth most common cancer worldwide and the sixth leading cause of cancer-related deaths. As a significant cause of morbidity and mortality, its burden on society has yet to be fully characterized. The aim of this study is to examine its global burden through estimation of the disability-adjusted life years (DALYs) attributable to it. METHODS: Global incidence and mortality estimates for esophageal cancer were obtained from the International Agency for Research on Cancer GLOBOCAN 2008 database. DALYs were calculated, using methodology established by the World Health Organization. RESULTS: In 2008, 3,955,919 DALYs were attributed to esophageal cancer, at a global rate of 0.58 DALYs per 1000 people annually. Years of life lost (YLL) accounted for 96.8 % of DALYs, while years lived with disability (YLD) accounted for 3.2 %. 83.8 % of the global DALYs occurred in less-developed countries, with most accrued in Eastern Asia, comprising 50.9 % of the total. The highest rate of DALY accrual was in Southern Africa, at 1.62 DALYs per 1000 people annually. CONCLUSIONS: A substantial number of years of life were lost or affected by esophageal cancer worldwide in 2008, with the burden resting disproportionately on less-developed countries. Geographically, the greatest burden is in Eastern Asia. The vast majority of DALYs were due to YLL, rather than YLD, indicating the need to focus resources on disease prevention and early detection. Our findings provide an additional basis upon which to formulate global priorities for interventions that affect DALY reduction in esophageal cancer.

Labia Minora, Labia Majora, and Clitoral Hood Alteration: Experience-Based Recommendations.

Aesthetic alteration of the genitalia is increasingly sought by women unhappy with the size, shape, and appearance of their vulva. Although the labia minora are usually the focus of concern, the entire anatomic region--minora, labia majora, clitoral hood, perineum, and mons pubis--should be evaluated in a preoperative assessment of women seeking labiaplasty. Labiaplasty is associated with high patient satisfaction and low complication rates. The three basic labia minora reduction techniques--edge excision, wedge excision, and central deepithelialization--as well as their advantages and disadvantages are discussed to assist the surgeon in tailoring technique selection to individual genital anatomy and aesthetic desires. We present key points of the preoperative anatomic evaluation, technique selection, operative risks, perioperative care, and potential complications for labia minora, labia majora, and clitoral hood alterations, based on a large operative experience. Labiaplasty competency should be part of the skill set of all plastic surgeons.

Nomogram for predicting the benefit of neoadjuvant chemoradiotherapy for patients with esophageal cancer: a SEER-Medicare analysis.

BACKGROUND: The survival impact of neoadjuvant chemoradiotherapy (CRT) on esophageal cancer remains difficult to establish for specific patients. The aim of the current study was to create a Web-based prediction tool providing individualized survival projections based on tumor and treatment data. METHODS: Patients diagnosed with esophageal cancer between 1997 and 2005 were selected from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. The covariates analyzed were sex, T and N classification, histology, total number of lymph nodes examined, and treatment with esophagectomy or CRT followed by esophagectomy. After propensity score weighting, a log-logistic regression model for overall survival was selected based on the Akaike information criterion. RESULTS: A total of 824 patients with esophageal cancer who were treated with esophagectomy or trimodal therapy met the selection criteria. On multivariate analysis, age, sex, T and N classification, number of lymph nodes examined, treatment, and histology were found to be significantly associated with overall survival and were included in the regression analysis. Preoperative staging data and final surgical margin status were not available within the SEER-Medicare data set and therefore were not included. The model predicted that patients with T4 or lymph node disease benefitted from CRT. The internally validated concordance index was 0.72. CONCLUSIONS: The SEER-Medicare database of patients with esophageal cancer can be used to produce a survival prediction tool that: 1) serves as a counseling and decision aid to patients and 2) assists in risk modeling. Patients with T4 or lymph node disease appeared to benefit from CRT. This nomogram may underestimate the benefit of CRT due to its variable downstaging effect on pathologic stage. It is available at skynet.ohsu.edu/nomograms.