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CivaSheet intraoperative radiation therapy for pancreatic cancer

Taylor, Ross J; Todor, Dorin; Kaplan, Brian J; Stover, Weston; Fields, Emma C
The treatment of borderline resectable (BR) pancreatic cancer is challenging and requires a multidisciplinary approach with chemotherapy, radiation and surgical resection. Despite using chemotherapy and radiotherapy in the neoadjuvant setting, achievement of negative surgical margins remains technically challenging. Positive margins are associated with increased local recurrences and worse overall survival and there are no standard options for treatment. The CivaSheet is an FDA-cleared implantable sheet with a matrix of unidirectional planar low-dose-rate (LDR) Palladium-103 (Pd-103) sources. The sources are shielded on one side with gold to spare radio-sensitive structures such as the bowel. The sheet can easily be customized and implanted at the time of surgery when there is concern for close or positive margins. The CivaSheet provides an interesting solution to target the region of close/positive margins after pancreatectomy. Here we discuss the physical properties, the dosimetry, clinical workflow and early patient outcomes with the CivaSheet in pancreatic cancer.
PMID: 35031255
ISSN: 1873-1449
CID: 5436032

First report on the feasibility of a permanently implantable uni-directional planar low dose rate brachytherapy sheet for patients with resectable or borderline resectable pancreatic cancer

Dault, Joshua B; Todor, Dorin; Kaplan, Brian J; Myers, Jennifer L; Fields, Emma C
BACKGROUND:Margin negative resection in pancreatic cancer remains the only curative option but is challenging, especially with the retroperitoneal margin. Intraoperative radiation therapy (IORT) can improve rates of local control but requires specially designed facilities and equipment. This retrospective review describes initial results of a novel implantable mesh of uni-directional low dose rate (LDR) Pd-103 sources (sheet) used to deliver a focal margin-directed high-dose boost in patients with concern for close or positive margins. METHODS:Eleven consecutive patients from a single institution with resectable or borderline resectable pancreatic cancer with concern for positive margins were selected for sheet placement and retrospectively reviewed. Procedural outcomes, including the time to implant the device and complications, and clinical outcomes, including survival and patterns of failure, are reported. A dosimetric comparison of the LDR sheet with hypothetical stereotactic body radiotherapy (SBRT) boost is reported. RESULTS:One patient had a resectable disease, and 10 patients had a borderline resectable disease and underwent neoadjuvant treatment. Sheet placement added 15 min to procedural time with no procedural or sheet-related complications. At a median follow up of 13 months, 64% (n = 7) of patients are alive and 55% (n = 6) are disease-free. Compared to a hypothetical SBRT boost, the LDR sheet delivered a negligible dose to kidneys, liver, and spinal cord with a 50% reduction in max dose to the small bowel. CONCLUSION:This is the first report of the use of an implantable uni-directional LDR brachytherapy sheet in patients with resected pancreatic cancer with concern for margin clearance, with no associated toxicity and favorable clinical outcomes.
PMID: 32978081
ISSN: 1873-1449
CID: 5435742

Esophagus and Gastrointestinal Junction Tumors

Kurtom, Saba; Kaplan, Brian J
Esophageal squamous cell carcinoma and adenocarcinoma account for 95% of all esophageal malignancies. The rates of esophageal adenocarcinoma have increased in Western countries, making it the predominant type of esophageal cancer. Treatment of both types of cancer has transformed to a more minimally invasive approach, with endoscopic methods being used for superficial cancers and more frequent use of video-assisted and laparoscopic modalities for locally advanced tumors. The current National Comprehensive Cancer Network guidelines advocate a trimodal approach to treatment, with neoadjuvant chemoradiation and surgery for locally advanced cancers.
PMID: 32402297
ISSN: 1558-3171
CID: 5436102

Ivor Lewis vs Mckeown esophagectomy: analysis of operative outcomes from the ACS NSQIP database

Sabra, M J; Alwatari, Y A; Wolfe, L G; Xu, A; Kaplan, B J; Cassano, A D; Shah, R D
OBJECTIVES/OBJECTIVE:Ivor Lewis and McKeown esophagectomy are common techniques to treat esophageal cancer. In this study, we aim to compare these two approaches. METHOD/METHODS:We used the American College of Surgeons National Surgical Quality Improvement Project database (2005-2017) to compare both techniques using bivariate analysis after propensity matching. RESULTS:We identified 6136 patients with esophagectomy and divided them into 2 groups based on whether they received a McKeown (1676; 27.31%) or an Ivor Lewis (4460; 70.14%) esophagectomy. McKeown esophagectomy was associated with higher rates of superficial surgical site infections (8.02% vs 3.67%, p < 0.001), anastomotic leaks (9.12% vs 7.71%, p = 0.02), prolonged intubation (15.06% vs 10.10%, p < 0.001), re-intubation (15.30% vs 10.34%, p ≤ 0.001), and return to the OR (16.46% vs 11.32%, p < 0.001). The McKeown esophagectomy patients also had longer hospital length of stay (14.5 ± 11.99 vs 13.37 ± 11.8, p = 0.002), higher re-admission rate (21.56% vs 16.87%, p = 0.002), and higher discharges to nursing/rehabilitation institutions (14.06% vs 11.99%, p = 0.004).The mortality rate and positive resection margins were not significantly different. There was a trend toward more utilization of Ivor Lewis esophagectomy over years. CONCLUSION/CONCLUSIONS:When compared to Ivor Lewis esophagectomy, McKeown esophagectomy is associated with more unplanned intubation, increased difficulty weaning from the ventilator, incisional surgical site infections, anastomotic leak, and higher length of stay.
PMID: 31933140
ISSN: 1863-6713
CID: 5436042

Community level socioeconomic status association with surgical outcomes and resource utilisation in a regional cohort: a prospective registry analysis

Mehaffey, J Hunter; Hawkins, Robert B; Charles, Eric J; Turrentine, Florence E; Kaplan, Brian; Fogel, Sandy; Harris, Charles; Reines, David; Posadas, Jorge; Ailawadi, Gorav; Hanks, John B; Hallowell, Peter T; Jones, R Scott
BACKGROUND:Socioeconomic status affects surgical outcomes, however these factors are not included in clinical quality improvement data and risk models. We performed a prospective registry analysis to determine if the Distressed Communities Index (DCI), a composite socioeconomic ranking by zip code, could predict risk-adjusted surgical outcomes and resource utilisation. METHODS:All patients undergoing surgery (n=44,451) in a regional quality improvement database (American College of Surgeons-National Surgical Quality Improvement Program ACS-NSQIP) were paired with DCI, ranging from 0-100 (low to high distress) and accounting for unemployment, education level, poverty rate, median income, business growth and housing vacancies. The top quartile of distress was compared to the remainder of the cohort and a mixed effects modeling evaluated ACS-NSQIP risk-adjusted association between DCI and the primary outcomes of surgical complications and resource utilisation. RESULTS:A total of 9369 (21.1%) patients came from severely distressed communities (DCI >75), who had higher rates of most medical comorbidities as well as transfer status (8.4% vs 4.8%, p<0.0001) resulting in higher ACS-NSQIP predicted risk of any complication (8.0% vs 7.1%, p<0.0001). Patients from severely distressed communities had increased 30-day mortality (1.8% vs 1.4%, p=0.01), postoperative complications (9.8% vs 8.5%, p<0.0001), hospital readmission (7.7 vs 6.8, p<0.0001) and resource utilisation. DCI was independently associated with postoperative complications (OR 1.07, 95% CI 1.04 to 1.10, p<0.0001) as well as resource utilisation after adjusting for ACS-NSQIP predicted risk CONCLUSION: Increasing Distressed Communities Index is associated with increased postoperative complications and resource utilisation even after ACS-NSQIP risk adjustment. These findings demonstrate a disparity in surgical outcomes based on community level socioeconomic factors, highlighting the continued need for public health innovation and policy initiatives.
PMID: 31540969
ISSN: 2044-5423
CID: 5435722

Simplified preoperative tool predicting discharge destination after major oncologic gastrointestinal surgery

Ramanathan, Rajesh; Rieser, Caroline; Kurtom, Saba; Rustom, Salem; Subramany, Revathy; Wolfe, Luke G; Kaplan, Brian J
BACKGROUND:Preoperatively identifying patients who will require discharge to extended care facilities (ECFs) after major cancer surgery is valuable. This study compares existing models and derives a simple, preoperative tool for predicting discharge destination after major oncologic gastrointestinal surgery. METHODS:The American College of Surgeon National Surgical Quality Improvement datasets were used to evaluate existing risk stratification and frailty assessment tools between the years 2011 and 2015. A novel tool for predicting discharge to ECF was developed in the 2011-2015 dataset and subsequently validated in the 2016 dataset. RESULTS:Major resections were analyzed for 61 683 malignancies: 6.9% esophagus, 5.3% stomach, 20.0% liver, 21.0% pancreas, and 46.8% colon/rectum. The overall ECF discharge rate was 9.1%. The American Society of Anesthesiologist score, 11-point modified frailty index (mFI), and 5-point abbreviated modified frailty index (amFI) demonstrated only moderate discrimination in predicting ECF discharge (c-statistic: 0.63-0.65). In contrast, our weighted cancer cancer abbreviated modified frailty index (camFI) score demonstrated improved discrimination with c-statistic of 0.73. The camFI displayed >90% negative predictive value for ECF discharge at every operative site. CONCLUSION/CONCLUSIONS:The camFI is a simple tool that can be used preoperatively to counsel patients on their risk of ECF discharge, and to identify patients with the least need for ECF discharge after major oncologic gastrointestinal surgery.
PMID: 31792986
ISSN: 1096-9098
CID: 5435982

Otolaryngology Resident Well-Being and Perceptions of the Clinical Learning Environment

Dodson, Kelley M; Appelbaum, Nital P; Lee, Nathaniel; Amendola, Michael; Kaplan, Brian
OBJECTIVE:To measure the current state of organizational and well-being factors in otolaryngology residency programs and associate these perceptions with demographics, pursuit of subspecialty fellowships, and performance on the Otolaryngology Training Examination (OTE). MATERIALS AND METHODS/METHODS:Anonymous mail and online survey study of otolaryngology residents from the Southern, Mid-Atlantic, and East South-Central Regions of the United States. SUMMARY OF RESULTS/RESULTS:= 0.15. CONCLUSION/CONCLUSIONS:For otolaryngology residents in this survey sample, the perception of organizational support and well-being may influence resident performance (on OTE examinations) and ultimate career goals (fellowship applications). Program directors and coordinators can use this information to strengthen the perceptions of organizational support as well as improve the clinical learning environment to optimize training conditions for their residents. Residency program directors can also use the identified study measures to assess resident perceptions of the clinical learning environment and well-being for annual evaluation and improvement purposes.
PMID: 30974991
ISSN: 1942-7522
CID: 5435942

Age-related risks of complications after distal pancreatectomy for neuroendocrine and cystic neoplasms

Ramanathan, Rajesh; Al Abbas, Amr I; Mason, Travis; Wolfe, Luke G; Kaplan, Brian J
BACKGROUND:Distal pancreatic neuroendocrine tumors (PNET) and pancreatic cystic neoplasms (PCN) are often incidentally found in older adults, requiring careful consideration between operative management and watchful waiting. This study analyzes the short-term complications associated with distal pancreatectomy (DP) for PNET and PCN in older adults to inform clinical decision-making. METHODS:Patients undergoing DP for PNET and PCN were analyzed using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database and the pancreatectomy procedure-targeted dataset. Associations between decade of age and 30-day outcomes were evaluated. RESULTS:1626 patients were analyzed from 2014 to 2015. 692 (42.6%) were younger than 60 years, 507 (31.2%) were sexagenarians, 342 (21.0%) were septuagenarians, and 85 (5.2%) were octogenarians. Minimally invasive approaches were used in 62.7%. While septuagenarians and octogenarians constituted 26.3% of the cohort, they were affected by 55.6% of reintubations, 66.7% of failures to wean, 82.4% of myocardial infarctions, and 57.1% of septic shock. Septuagenarians and octogenarians had longer hospital stays, as compared to those younger than 60 years. CONCLUSION:Septuagenarians and octogenarians are disproportionately affected by perioperative complications after DP for PNET and PCN. Careful patient selection and thorough counseling should be provided when surgery is considered.
PMID: 30528554
ISSN: 1477-2574
CID: 5435972

Adjuvant radiation therapy for T4 non-rectal colon adenocarcinoma provides a cause-specific survival advantage: A SEER database analysis

McLaughlin, Christopher; Kim, Nak-Kyeong; Bandyopadhyay, Dipankar; Deng, Xiaoyan; Kaplan, Brian; Matin, Khalid; Fields, Emma C
PURPOSE:While there is no level 1 evidence supporting the use of adjuvant radiotherapy (RT) for non-rectal colon cancer in the modern chemotherapy era, there are studies that suggest a local control benefit. This treatment modality is not part of standard treatment recommendations, and we hypothesized that adjuvant RT provides a benefit in locally advanced disease. Due to the limited number who receive post-operative RT, a national database was searched to provide sufficient power. MATERIALS AND METHODS:A retrospective analysis using the Surveillance, Epidemiology, and End Results (SEER) database was performed. Inclusion criteria were: non-rectal colon cancer, AJCC 6th or 7th edition T4 and M0, oncologic resection, and 1st cancer site. Patients were excluded for RT prior to or during surgery, or if the sequence of RT was unknown. Using a Cox proportional hazard model, the relative risk of cause-specific mortality for "RT after surgery" versus "No RT" was calculated. RESULTS:21,789 patients were identified who met the inclusion criteria. Of these, only 1001 received adjuvant RT, and 64% were node-positive (53% RT vs. 65% no RT). When comparing RT vs. no RT, after adjusting for sex, age, N stage, and grade, we determined the relative risk of death from cancer was 0.8849 (95% CI: 0.8008-0.9779; p = 0.0165), suggesting that only 14 patients with T4 disease need receive adjuvant radiation to spare a cancer-related death. CONCLUSIONS:Adjuvant RT is not routinely utilized for definitive treatment of T4 non-rectal colon cancer, but this analysis shows a significant cause-specific survival benefit.
PMID: 30935581
ISSN: 1879-0887
CID: 5435712

Surgical Resident Burnout and Job Satisfaction: The Role of Workplace Climate and Perceived Support

Appelbaum, Nital P; Lee, Nathaniel; Amendola, Michael; Dodson, Kelley; Kaplan, Brian
BACKGROUND:Surgical residents train under immense stress, often manifesting into poor well-being. While recent research identifies methods of coping with stress, few studies empirically investigate the role of the environment on surgical resident well-being. We aimed to assess surgical resident perceptions of workplace climate, organizational support, burnout, and job satisfaction to test a mediation model identifying antecedents to well-being. MATERIALS AND METHODS:A convenience sampling of program directors from general surgery within the Eastern region of the United States were emailed to request either agenda time to collection data via paper survey or to forward an electronic survey link to their residents between March 2016 and June 2016. The survey included scales demonstrating validity evidence on well-being, climate, and perceptions of support. RESULTS:Based on 160 general surgery residents (out of 557; 29% response rate) across 19 training programs, our mediation model found that job satisfaction was significantly predicted by workplace climate directly (direct effect = 0.37, 95% CI [0.19, 0.55]) and indirectly (specific indirect effect = 0.07, 95% CI [0.01, 0.13]) through perceived organizational support and burnout, while controlling for training year and gender, F(5,147) = 53.76, P < 0.001, Rsq. = 0.65. CONCLUSIONS:Medical education requires an additional focus on how the clinical learning environment affects surgical resident well-being. Health systems and training programs will need to collaborate on workplace innovations to improve workplace climate for trainees to address the concerns of well-being with a modern surgical workforce.
PMID: 30527474
ISSN: 1095-8673
CID: 5435932