Enhancing Lymph Node Yield in Gastric Cancer Resection: Impact of Back Table Dissection on Number of Lymph Node Examined.

INTRODUCTION: During gastric cancer resection, back table dissection (BTD) involves examination and separation of lymph node (LN) packets from the surgical specimen based on LN stations, which are sent to pathology as separately labeled specimens. With potential impact on clinical outcomes, we aimed to explore how BTD affects number of LNs examined. METHODS: A retrospective review of a gastric cancer database was performed, including all cases of gastrectomy with D2 lymphadenectomy from January 2009 to March 2022. Back table dissection and conventional groups were compared using Mann-Whitney U and Fisher's exact tests. Multiple linear regression modeling was used to identify potential predictors of number of LN examined. RESULTS: A total of 174 patients were identified: 39 (22%) BTD and 135 (78%) conventional. More patients in the BTD group underwent neoadjuvant chemotherapy (62% vs 29%, P < .05). Compared to the conventional group, the BTD group had a greater number of LNs examined (42 [26-59] vs 21[15-33], median [IQR], P < .001), lower LN positivity ratio (.01 vs .07, P = .013), and greater number of LNs in patients with BMI >35 (32.5[27.5-39] vs 22[13-27], P = .041). A multiple linear regression model controlling for age, BMI, preoperative N stage, neoadjuvant chemotherapy, surgeon experience, and operative approach identified BTD as a significant positive predictor of number of LN examined (ß = 19.7, P = .001). CONCLUSION: Back table dissection resulted in improved LN yield during gastric cancer resection. As a simple technical addition, BTD helps enhance pathology examination and improve surgeon awareness, which may ultimately translate to improve oncologic outcomes.

Real world study of sacituzumab govitecan in metastatic triple-negative breast cancer in the United Kingdom.

BACKGROUND: Treatment options for pre-treated patients with metastatic triple-negative breast cancer (mTNBC) remain limited. This is the first study to assess the real-world safety and efficacy of sacituzumab govitecan (SG) in the UK. METHODS: Data was retrospectively collected from 16 tertiary UK cancer centres. Pts had a diagnosis of mTNBC, received at least two prior lines of treatment (with at least one being in the metastatic setting) and received at least one dose of SG. RESULTS: 132 pts were included. Median age was 56 years (28-91). All patients were ECOG performance status (PS) 0-3 (PS0; 39, PS1; 76, PS2; 16, PS3;1). 75% (99/132) of pts had visceral metastases including 18% (24/132) of pts with CNS disease. Median PFS (mPFS) was 5.2 months (95% CI 4.5-6.6) with a median OS (mOS) of 8.7 months (95% CI 6.8-NA). The most common adverse events (AEs) were fatigue (all grade; 82%, G3/4; 14%), neutropenia (all grade; 55%, G3/4; 29%), diarrhoea (all grade; 58%, G3/4, 15%), and nausea (all grade; 38%, G3/4; 3%). SG dose reduction was required in 54% of pts. CONCLUSION: This study supports significant anti-tumour activity in heavily pre-treated pts with mTNBC. Toxicity data aligns with clinical trial experience.

A Prospective Study of Sentinel Node Biopsy Omission in Women Age ≥ 65 Years with ER+ Breast Cancer.

BACKGROUND: National guidelines recommend omitting SNB in older patients with favorable invasive breast cancer. However, there is a lack of prospective data specifically addressing this issue. This study evaluates recurrence and survival in estrogen receptor-positive/Her2- (ER+) breast cancer patients, aged ≥ 65 years who have breast-conserving surgery (BCS) without SNB. METHODS: This is a prospective, observational study at a single institution where 125 patients aged ≥ 65 years with clinical T1-2N0 ER+ invasive breast cancer undergoing BCS were enrolled. Patients were treated with BCS without SNB. Primary outcome measure was axillary recurrence. Secondary outcome measures include recurrence-free survival (RFS), disease-free survival (DFS), breast cancer-specific survival (BCSS), and overall survival (OS). RESULTS: From January 2016 to July 2022, 125 patients were enrolled with median follow-up of 36.7 months [95% confidence interval (CI) 35.0-38.0]. Median age was 77.0 years (range 65-93). Median tumor size was 1 cm (range 0.1-5.0). Most tumors were ductal (95/124, 77.0%), intermediate grade (60/116, 51.7%), and PR-positive (117/123, 91.7%). Radiation therapy was performed in 37 of 125 (29.6%). Only 60 of 125 (48.0%) who were recommended hormonal therapy were compliant at 2 years. Chemotherapy was administered to six of 125 (4.8%) patients. There were two of 125 (1.6%) axillary recurrences. Estimated 3-years rates of regional RFS, DFS, and OS were 98.2%, 91.2%, and 94.8%, respectively. Univariate Cox regression identified hormonal therapy noncompliance to be significantly associated with recurrence (p = 0.02). CONCLUSIONS: Axillary recurrence rates were extremely low in this cohort. These results provide prospective data to support omission of SNB in this patient population TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02564848.

Implementation of Exercise Management Services Among Sports Medicine Physicians in the United States.

OBJECTIVE: Assessment of physical activity and exercise prescription has been widely supported by many organizations, yet provision of such services remains limited in the United States. We sought to uncover why such services have not been widely adopted. DESIGN: The American Medical Society for Sports Medicine organized a task force to canvas physicians and survey the American Medical Society for Sports Medicine membership. SETTING: Peer-to-peer and telecommunication discussions and web-based questionnaires. PARTICIPANTS: Sports medicine physicians in the United States. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Percentage of sports medicine physicians who provide exercise management services and mechanisms of billing for exercise management, identify barriers to such services, and identify industry collaborations for promoting physical activity through physicians. RESULTS: Three of 4 sports medicine physicians spend at least 1 min encouraging exercise with patients, using Evaluation and Management codes to bill or receive credit. Exercise counseling is often bundled within other patient care. Few health plans leverage the patient's relationship with a primary care physician to promote exercise. Most employed sports medicine physicians do not receive incentives to incorporate exercise counseling into practice, and only 1 in 6 have decision-making authority to hire an exercise professional. Major obstacles are the lack of a business model and knowledge about exercise prescription. CONCLUSION: The existing E&M codes adequately characterize the work, but physicians desire greater payment or credit for providing exercise management services. Physicians desire to do more exercise prescription, but health system bureaucracy, inadequate support, and economic disincentives are barriers to the provision of exercise management services.

Different-sized extracellular vesicles derived from stored red blood cells package diverse cargoes and cause distinct cellular effects.

BACKGROUND: The formation of extracellular vesicles (EVs) occurs during cold storage of RBCs. Transfusion of EVs may contribute to adverse responses in recipients receiving RBCs. However, EVs are poorly characterized with limited data on whether distinct vesicles are formed, their composition, and potential biological effects. STUDY DESIGN AND METHODS: Stored RBC-derived EVs were purified using protocols that separate larger microvesicle-like EVs (LEVs) from smaller exosome-like vesicles (SEVs). Vesicles were analyzed by electron microscopy, content of hemoglobin, heme, and proteins (by mass spectrometry), and the potential to mediate lipid peroxidation and endothelial cell permeability in vitro. RESULTS: SEVs were characterized by having an electron-dense double membrane whereas LEVs had more uniform electron density across the particles. No differences in hemoglobin nor heme levels per particle were observed, however, due to smaller volumes, SEVs had higher concentrations of oxyHb and heme. Both particles contained antioxidant proteins peroxiredoxin-2 and copper/zinc superoxide dismutase, these were present in higher molecular weight fractions in SEVs suggesting either oxidized proteins are preferentially packaged into smaller vesicles and/or that the environment associated with SEVs is more pro-oxidative. Furthermore, total glutathione (GSH + GSSG) levels were lower in SEVs. Both EVs mediated oxidation of liposomes that were prevented by hemopexin, identifying heme as the pro-oxidant effector. Addition of SEVs, but not LEVs, induced endothelial permeability in a process also prevented by hemopexin. CONCLUSION: These data show that distinct EVs are formed during cold storage of RBCs with smaller particles being more likely to mediate pro-oxidant and inflammatory effects associated with heme.

Physician Nutrition Advice and Referrals to Registered Dietitians.

PURPOSE: This study aims to examine the frequency and content of healthcare providers' nutrition recommendations and referrals Registered Dietitian Nutritionists (RDN). METHODS: Physicians, physician assistants, nurses, and other providers (> 18 years of age) currently practicing primarily in the United States received an email survey that assessed dietary recommendations for diabetes, hypertension, dyslipidemia, overweight/obesity, and general wellbeing, frequency and comfort level of providing nutrition advice, and RDN referrals. Chi-square and Student's t-tests were used for analysis. RESULTS: 154 physicians (61%), registered nurses/nurse practitioners/physician assistants (19.5%), and other providers (19.5%) were included. Those with nutrition education gave nutrition advice more than those without for some, but not all, conditions (P = .01). The Mediterranean diet was most frequently recommended, except for hypertension. The DASH diet was recommended to 47.7% of patients with hypertension. More providers gave dietary advice than referred to RDNs. Dietary advice was associated with RDN referrals for diabetes (P = .01) and wellbeing (P = .05). Providers with an RDN in their practice provided advice for diabetes more than those without (P = .01). CONCLUSION: Healthcare providers gave nutrition recommendations consistent with evidence-based guidance. RDN referrals occur in conjunction with dietary recommendations, not as replacement.

Use of fluorescence imaging and indocyanine green during laparoscopic cholecystectomy: Results of an international Delphi survey.

BACKGROUND: Published empirical data have increasingly suggested that using near-infrared fluorescence cholangiography during laparoscopic cholecystectomy markedly increases biliary anatomy visualization. The technology is rapidly evolving, and different equipment and doses may be used. We aimed to identify areas of consensus and nonconsensus in the use of incisionless near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. METHODS: A 2-round Delphi survey was conducted among 28 international experts in minimally invasive surgery and near-infrared fluorescent cholangiography in 2020, during which respondents voted on 62 statements on patient preparation and contraindications (n = 12); on indocyanine green administration (n = 14); on potential advantages and uses of near-infrared fluorescent cholangiography (n = 18); comparing near-infrared fluorescent cholangiography with intraoperative x-ray cholangiography (n = 7); and on potential disadvantages of and required training for near-infrared fluorescent cholangiography (n = 11). RESULTS: Expert consensus strongly supports near-infrared fluorescent cholangiography superiority over white light for the visualization of biliary structures and reduction of laparoscopic cholecystectomy risks. It also offers other advantages like enhancing anatomic visualization in obese patients and those with moderate to severe inflammation. Regarding indocyanine green administration, consensus was reached that dosing should be on a milligrams/kilogram basis, rather than as an absolute dose, and that doses >0.05 mg/kg are necessary. Although there is no consensus on the optimum preoperative timing of indocyanine green injections, the majority of participants consider it important to administer indocyanine green at least 45 minutes before the procedure to decrease the light intensity of the liver. CONCLUSION: Near-infrared fluorescent cholangiography experts strongly agree on its effectiveness and safety during laparoscopic cholecystectomy and that it should be used routinely, but further research is necessary to establish optimum timing and doses for indocyanine green.

Efficacy of Eribulin in Soft Tissue Sarcomas.

Soft tissue sarcomas are a highly heterogenous group of tumors with limited systemic therapy options. Eribulin, a synthetic analogue of halichondrin B, is a potent mitotic inhibitor. A phase 3 trial of previously treated advanced Liposarcoma and Leiomyosarcoma demonstrated superiority of eribulin to dacarbazine. Eribulin appears to be particularly effective for liposarcomas. It has also been shown to be a safe and effective treatment alternative to doxorubicin in patients where doxorubicin is contraindicated. From retrospective studies, eribulin has demonstrated efficacy in patients with angiosarcoma, pleomorphic sarcomas, synovial sarcomas, rhabdomyosarcomas, angiosarcomas, and myxofibrosarcomas. Future areas of development include liposomal eribulin, which may provide increased efficacy and lower toxicity, and delineation of biomarkers of response and resistance, allowing better selection of patients for treatment.

Outcomes Following Percutaneous Cholecystostomy Tube Placement for Acalculous Versus Calculous Cholecystitis.

BACKGROUND: Acute acalculous cholecystitis (AAC) is often diagnosed in critically ill patients. Percutaneous cholecystostomy tube (PCT) placement facilitates less invasive gallbladder decompression in patients who are poor surgical candidates. Specific guidelines for optimal management of AAC patients following PCT placement remain to be defined. We hypothesize that AAC patients are at lower risk of recurrent cholecystitis than acute calculous cholecystitis (ACC) patients and do not require cholecystectomy after PCT placement. METHODS: A retrospective review of patients who underwent PCT placement for AAC or ACC between 6/1/2007 and 5/31/2019 was performed. Primary outcome was recurrent cholecystitis and interval cholecystectomy for patients surviving 30 days after PCT placement. Secondary outcome was 30 day mortality. A cox regression model calculated the adjusted hazard ratio (AHR) for the outcomes. RESULTS: Eighty-four AAC and 85 ACC patients underwent PCT placement. Compared to ACC patients, more AAC patients were male (72.6 vs. 48.2%; p < 0.01), younger (median age 62 vs. 73 years; p < 0.01), and required intensive care (69.0 vs. 52.9%; p = 0.04), with lower median Charlson Comorbidity Index (4.0 vs. 6.0; p < 0.01). 30 day mortality was higher among AAC patients than ACC patients (45.2 vs. 21.2%; p < 0.01). 2/24 (8.3%) AAC patients and 5/31 (16.1%) ACC patients developed recurrent cholecystitis at a median 208.0 days (IQR:64.0-417.0) after PCT placement and 115.0 days (IQR:7.0-403.0) following PCT removal. Cox regression analysis demonstrated that AAC patients had lower likelihood of interval cholecystectomy compared to ACC patients (AHR 2.35; 95% CI:1.11,4.96). CONCLUSION: Recurrent cholecystitis is rare in patients surviving 30 days following PCT placement. When compared with ACC patients, fewer AAC patients require cholecystectomy.

Operative approach and case volume are associated with negative resection margins for adrenocortical carcinoma.

BACKGROUND: Surgical resection with negative margins is the treatment of choice for adrenocortical carcinoma (ACC). This study was undertaken to determine factors associated with negative resection margins. METHODS: National Cancer Database was queried from 2010 to 2016 to identify patients with AJCC/ENSAT Stage I-III ACC who underwent adrenalectomy. Patient, tumor, facility, and operative characteristics were compared by margin status (positive-PM or negative-NM) and operative approach (open-OA, laparoscopic-LA, or robotic-RA). Multivariable logistic regression was used to identify factors associated with PM. RESULTS: Eight hundred and eighty-one patients were identified, of which 18.4% had PM and 81.6% had NM. Patients with advanced pathologic T stage and pathologic N1 stage were more likely to have PM (vs. NM) (T3, 49.7% vs. 24.8%, p < 0.01; T4, 26.2% vs. 10.0%, p < 0.01; N1, 6.7% vs. 3.5%, p < 0.01). Patients undergoing OA (vs. LA and RA) were more likely to have advanced clinical T stage (T4, 16.6% vs. 5.7% vs. 7.8%, p < 0.01) and larger tumors (> 6 cm, 84.6% vs. 64.1% vs. 62.3%, p < 0.01). High-volume centers (≥ 5 cases) were more likely to utilize OA. Patients undergoing LA (vs. RA) were more likely to require conversion to open (20.3% vs. 7.8%, p = 0.011). On multivariable analysis, factors associated with higher odds of PM included T3 disease (OR 7.02, 95% CI 2.66-18.55), T4 disease (OR 10.22, 95% CI 3.66-28.53), and LA (OR 1.99, 95% CI 1.28-3.09). High-volume centers were associated with lower odds of PM (OR 0.67, 95% CI 0.45-0.98). There was no significant difference in margin status between OA and RA (OR 1.44, 95% CI 0.71-2.90). CONCLUSION: Centers with higher ACC case volumes have lower odds of PM and utilize OA more often. LA is associated with higher odds of PM, whereas RA is not. These factors should be considered when planning the operative approach for ACC.

Evaluation of a Whole Health-Lifestyle Medicine Curriculum for Physician Assistant Students: a Mixed Methods Analysis.

There is increased urgency to train healthcare professionals in lifestyle medicine (LM) to mitigate the impact of lifestyle factors on chronic disease (Trilk et al. in Am J Prevent Medic. 2019:e169-e75, 2019; Polak et al. in Am J Lifestyle Med. 2015;9:361-7, 2015). This training addresses physical activity, nutrition, stress management, sleep hygiene, relationships, tobacco cessation (Lifestyle medicine in ACLM Home, 2020), and self-care. Several studies have evaluated the impact of this training on physician assistant (PA) students (Keyes and Gardner in Clin Teach. 2020, 2020; Phillips et al. Med Sci Educ. 1-5). The current paper extends previous quantitative findings from Phillips et al., 2021, revealing positive qualitative changes in PA student language and approach to clinical vignettes after completion of a novel Whole Health/lifestyle medicine (WH-LM) curriculum.

The role of Cushing's reflex and the vasopressin-mediated oligoanuric response to intracranial hypertension in patients with abdominal compartment syndrome.

BACKGROUND: We examined the link between increased intra-abdominal pressure, intracranial pressure, and vasopressin release as a potential mechanism. Intra-abdominal pressure, produced by abdominal-cavity insufflation with carbon dioxide (CO2) during laparoscopic abdominal procedures to facilitate visualization, is associated with various complications, including arterial hypertension and oliguria. METHODS: Mean arterial pressure, optic nerve sheath diameter, measured as a proxy for intracranial pressure, plasma vasopressin, serum and urine osmolarity, and urine output were measured 4 times during laparoscopic sleeve gastrectomy in 42 patients: before insufflation with CO2 (T0); after insufflation to 15 cm water (H2O) pressure, with 5 cm H2O positive end-expiratory pressure (T1); after positive end-expiratory pressure was raised to 10 cm H2O (T2); and after a return to the baseline state (T3). Mean values at T0 to T3 and the directional consistency of changes (increase/decrease/ unchanged) were compared among the 4 data-collection points. RESULTS: Statistically significant elevations (all P ≤ .001) were noted from T0 to T1 and from T0 to T2 in mean arterial pressure, optic nerve sheath diameter, and vasopressin, followed by decreases at T3. For optic nerve sheath diameter and vasopressin, the increases at T1 and T2 occurred in 98% and 100% of patients, ultimately exceeding normal levels in 88 and 97%, respectively. Conversely, urine output fell from T0 to T1 and T2 by 60.9 and 73.4%, decreasing in 88.1% of patients (all P < .001). Patients with class II obesity exhibited statistically greater increases in optic nerve sheath diameter and vasopressin, but statistically less impact on urine output, than patients with class III obesity. CONCLUSION: Increased mean arterial pressure, intracranial pressure, and vasopressin release appear to be intermediary steps between increased intra-abdominal pressure and oliguria. Further research is necessary to determine any causative links between these physiological changes.

Percutaneous Cholecystostomy Tube for Acute Cholecystitis: Quantifying Outcomes and Prognosis.

BACKGROUND: Percutaneous cholecystostomy tubes (PCT) are utilized in the management of acute cholecystitis in patients deemed unsuitable for surgery. However, the drive for these decisions and the outcomes remain understudied. We sought to characterize the practices and utilization of PCT and evaluate associated outcomes at an urban medical center. METHODS: Patients undergoing PCT placement over a 12-y study period ending May 2019 were reviewed. Demographics, clinical presentation, labs, imaging studies, and outcomes were abstracted. The primary and secondary outcomes were 30-d mortality and interval cholecystectomy, respectively. RESULTS: Two hundred and four patients met inclusion criteria: 59.3% were male with a median age of 67.5 y and a National Surgical Quality Improvement Program (NSQIP) risk of serious complication of 8.0%. Overall, 57.8% of patients were located in an intensive care unit setting. The majority (80.9%) had an ultrasound and 48.5% had a hepatobiliary iminodiacetic acid scan. The overall 30-d mortality was 31.9%: 41.5% for intensive care unit and 18.6% for ward patients (P < 0.01). Of patients surviving beyond 30 d (n = 139), the PCT was removed from 106 (76.3%), and a cholecystectomy was performed in 55 (39.6%) at a median interval of 58.0 d. A forward logistic regression identified total bilirubin (Adjusted Odds Ratio: 1.12, adjusted P < 0.01) and NSQIP risk of serious complication (Adjusted Odds Ratio: 1.16, adjusted P < 0.01) as the only predictors for 30-d mortality. CONCLUSIONS: Patients selected for PCT placement have a high mortality risk. Despite subsequent removal of the PCT, the majority of surviving patients did not undergo an interval cholecystectomy. Total bilirubin and NSQIP risk of serious complication are useful adjuncts in predicting 30-d mortality in these patients.

Adrenocortical Carcinoma: The Value of Lymphadenectomy.

BACKGROUND: Adrenocortical carcinoma (ACC) staging does not account for the number of positive nodes. The prognostic value of quantitative metastatic nodal burden is unknown. METHODS: The National Cancer Database was retrospectively queried from 2004-2016 to identify patients with Stage I-III ACC undergoing adrenalectomy. Patients who underwent lymphadenectomy (LAD) were further studied. Demographics, TNM staging, tumor characteristics, and surgical approach were analyzed. RESULTS: 386 LADs were identified. The median number of nodes examined was 2 (IQR 2-6), with no difference by surgical approach '[laparoscopic, 3 (1-3); robotic, 1.5 (1-4.5); open, 2 (1-7), p = 0.493]. In LADs with cN0 disease, positive nodes were seen in 17.5% of patients; an average of 6 (1-12) nodes were examined in patients who upstaged to pN1 disease compared with an average of 2 (1-6) nodes in those who remained pN0. Median survival was incrementally worse for patients with more positive nodes (62.8 vs. 21.9 vs. 13.7 vs. 11.3 vs. 10.7 months for 0, 1, 2, 3, and ≥ 4 positive nodes, respectively, p < 0.01). On multivariate analysis, significant prognostic factors for poor survival included older age, ≥ 2 comorbidities, pT3, and pT4. The strongest prognostic factor for poor survival was the number of positive nodes (1 node, hazards ratio [HR] 2.3, 95% confidence interval [CI] 1.5-3.6; 2 nodes, HR 1.3, 95% CI 0.6-3.0; 3 nodes, HR 3.0, 95% CI 1.1-8.0; ≥ 4 nodes, HR 4.0, 95% CI 2.5-6.2). Lymphadenectomy was associated with improved survival (HR 0.82, 95% CI 0.67-0.99). CONCLUSIONS: Higher quantitative metastatic nodal burden is a robust prognostic factor for worse survival in ACC.

Management of Postcholecystectomy Complications.

Cholecystectomy is one of the most common general surgery procedures performed worldwide. Complications include bile duct injury, strictures, bleeding, infection/abscess, retained gallstones, hernias, and postcholecystectomy syndrome. Obtaining a critical view of safety and following the other tenets of the Safe Cholecystectomy Task Force will aid in the prevention of bile duct injury and other morbidity associated with cholecystectomy.

Training Physician Assistant Students to Provide Evidence-Based, Holistic, Patient-Driven Care: a Novel Curriculum.

Lifestyle and behavior modifications are the primary preventative strategies to mitigate the growing morbidity, mortality, and cost of chronic disease in the USA (Trilk et al., American Journal of Preventive Medicine 56:e169-e175, 2019); hence, there have been multiple calls to train all healthcare professionals in lifestyle medicine (LM). This paper describes and evaluates the implementation of a novel Whole Health/lifestyle medicine (WH-LM) education initiative for physician assistant (PA) students embedded within a clinical rotation at the VA Boston Healthcare System (VABHS). Students demonstrated increased knowledge of WH-LM principles and increased self-efficacy in utilizing these principles following training.

Factors Associated with Non-Operative Management of Resectable Adrenocortical Carcinoma.

INTRODUCTION: Surgery is the initial treatment of choice for patients with resectable adrenocortical carcinoma (ACC). We sought to determine factors associated with non-operative management of resectable ACC. METHODS: 2004-2016 National Cancer Database (NCDB) was queried to identify patients with AJCC/ENSAT Stage I-III ACC. Patients who underwent surgery (S) were compared to those who did not undergo surgery (NS). Multivariate logistic regression was used to identify factors associated with NS. Kaplan-Meier estimates used to assess survival. RESULTS: Two thousand-seventy patients with Stage I-III ACC were identified, of which 17.5% were NS. 85.9% of NS patients were not offered surgery; 69.9% of NS patients did not receive chemotherapy or radiation therapy. NS were older and less likely to receive care at an Academic center or high volume center (≥5 cases during the study period). NS patients were more likely to have advanced T stage and N1 disease. On multivariate regression, factors associated with lower odds of surgery include older age (OR 1.03, 95% CI 1.02-1.06), T4 disease (OR 3.34, 95% CI 1.05-10.68), and treatment at a community center (OR 2.92, 95% CI 1.58-5.40). Overall median survival was significantly poorer for NS patients (50.4 versus 78.4 months, P < 0.01). CONCLUSION: Patients with locally advanced ACC are less likely to undergo an operation, while those treated at centers with more operative experience or Academic facilities are more likely to undergo an operation. As the surgery-first approach is the current standard of care for resectable ACC, these patients may be best served at high volume Academic facilities.

Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.

Comparing clinical outcomes of image-guided percutaneous transperitoneal and transhepatic cholecystostomy for acute cholecystitis.

BACKGROUND: Percutaneous cholecystostomy is performed by interventional radiologists for patients with calculous/acalculous cholecystitis who are poor candidates for cholecystectomy. Two anatomical approaches are widely utilized: transperitoneal and transhepatic. PURPOSE: To compare the clinical outcomes of transperitoneal and transhepatic approaches to cholecystostomy catheter placement. MATERIAL AND METHODS: From December 2007 to August 2015, 165 consecutive patients (97 men, 68 women) underwent either transperitoneal (n = 89) or transhepatic (n = 76) cholecystostomy at a single center. Indications were calculous cholecystitis (n = 21), acalculous cholecystitis (n = 35), hydrops (n = 1), gangrenous cholecystitis (n = 1), and other cholecystitis (n = 107). The most common high-risk co-morbidities were sepsis (n = 53) and cardiac (n = 11). Outcomes were compared using univariate and multivariable analysis. RESULTS: Post-procedure outcomes included tube dislodgement (transperitoneal [n = 6] and transhepatic [n = 3], P = 0.44), bile leak (transperitoneal [n = 5], transhepatic [n = 1], P = 0.14), gallbladder hemorrhage (transperitoneal [n = 2]; transhepatic [n = 3], P = 0.52), duodenal fistula (transperitoneal [n = 0], transhepatic [n = 1], P = 0.27), repeat cholecystostomy (transperitoneal [n = 1], transhepatic [n = 3], P = 0.27), and repeat cholecystitis requiring separate admission (transperitoneal [n = 6], transhepatic [n = 10], P = 0.15). All complications were Common Terminology Criteria for Adverse Events grade <3. Twenty transperitoneal patients underwent post-procedure cholecystectomy: 13 laparoscopic, three open, and four unclear/outside records. The mean time from cholecystostomy to operation was 38 days (range 3-211 days). Twenty-three transhepatic patients underwent cholecystectomy: 14 laparoscopic, eight open, and one unclear/outside records, with the mean time from cholecystostomy being 98 days (range 0-1053 days). One transhepatic and three transperitoneal patients died during admission. CONCLUSION: There were no significant differences in short-term complications after transperitoneal and transhepatic approaches to percutaneous cholecystostomy catheter placement.