Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) learning curve: a regression analysis of complication rates and severity.

BACKGROUND: Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) is a natural orifice transluminal endoscopic surgery that offers a truly scarless approach to thyroidectomy. Introduced in 2008, there is a growing body of literature establishing it as a safe endoscopic approach for thyroid procedures. While it is not yet widely practiced, it is quickly growing in popularity. As more surgeons begin to add this technique to their repertoire the question of the learning curve has to be examined. METHODS: Case series from the initial TOETVA operations of four surgeons at three different hospitals were examined. Binomial and ordinal logistic regression were used to characterize the changes in complication rate and severity as they related to case number in the series. Statistics were performed in Minitab and SAS. RESULTS: Each surgeon performed between 23 and 40 TOETVA operations for a total of 130 cases. Binary logistic regression shows a negative relationship between case number and complication rate (P < 0.001, Odds Ratio: 0.91). Ordinal logistic regression shows a negative relationship between case number and complication severity (P < 0.001, Odds Ratio: 1.07). The maximum slope of improvement of complication rate occurred at case number 12. CONCLUSION: The most significant decrease in complications for TOETVA occurs at case 12. As case number progresses, there is a significant decrease in both the risk of a complication occurring and of the severity of that complication. These results support the previously published data on TOETVA learning curve based on operative time.

Correlating the Bethesda System for Reporting Thyroid Cytopathology with Histology and Extent of Surgery: A Review of 21,746 Patients from Four Endocrine Surgery Registries Across Two Continents.

BACKGROUND: The Bethesda system for cytopathology (TBSRTC) is a 6-tier diagnostic framework developed to standardize thyroid cytopathology reporting. The aim of this study was to determine the risk of malignancy (ROM) for each Bethesda category. METHODS: Thyroidectomy-related data from 314 facilities in 22 countries were entered into the following outcome registries: CESQIP (North America), Eurocrine (Europe), SQRTPA (Sweden) and UKRETS (UK). Demographic, cytological, pathologic and extent of surgery data were mapped into one dataset and analyzed. RESULTS: Out of 41,294 thyroidectomy patient entries from January 1, 2015, to June 30, 2017, 21,746 patients underwent both thyroid FNA and surgery. A comparison of cytology and surgical pathology data demonstrated a ROM for Bethesda categories 1 to 6 of 19.2%, 12.7%, 31.9%, 31.4%, 77.8% and 96.0%, respectively. Male patients had a higher rate of malignancy for every Bethesda category. Secondary analysis demonstrated a high ROM in male patients with Bethesda 3 category aged 31-35 years (52.1%, 95% confidence interval (CI) 37.9-66.2%), aged 36-40 years (55.9%, 95% CI 39.2-72.6%) and aged 41-45 years (46.9%, 95% CI 33-60.9%). Patients with Bethesda 5 and 6 scores were more likely to undergo total thyroidectomy (65.9% and 84.6%); for patients with Bethesda scores 2 and 3, a higher percentage of females underwent total thyroidectomy compared to males in spite of a higher ROM for males. CONCLUSIONS: These data demonstrate that Bethesda categories 1-4 are associated with a higher ROM compared to the first edition of TBSRTC, especially in male patients, and validate findings from the second edition of TBSRTC.

Transoral Endoscopic Thyroidectomy Vestibular Approach: A Single-institution Experience of the First 50 Cases.

Background. Transoral endoscopic thyroidectomy vestibular approach (TOETVA) has evolved from a novel procedure to a cosmetically appealing alternative to the traditional open thyroidectomy. TOETVA is limited to only high-volume centers with the hope to expand and demonstrate the safety, reproducibility, and application for the correct patient with thyroid disease. We present our experience with the first 50 TOETVA procedures performed at our institution. Methods. From September 2016 to June 2018, we performed 50 transoral endoscopic thyroidectomies via the vestibular approach for a variety of thyroid pathologies. Outcomes were analyzed from a prospectively maintained database. Patients were treated for a different range of thyroid pathologies. Results. A total of 12 (24%) patients underwent total thyroidectomy, whereas 38 (76%) patients underwent a subtotal thyroidectomy or thyroid lobectomy. The mean surgical time was 149 ± 40.0 (90-256) minutes for lobectomy and 217.6 ± 33.3 (175-276) minutes for total thyroidectomy. Of our 50 patients, 16 (32%) had postoperative transient lower lip numbness with an average time to recovery of 23.8 (.43-48) weeks, with 1 (2%) patient having persistent, but improving, lower lip numbness beyond the 6-month follow-up. There were 13 (26%) patients with transient chin numbness with an average time to recovery of 15.7 (2-48) weeks. Two (4%) patients had transient recurrent laryngeal nerve (RLN) injury with hoarseness, whereas 1 (2%) patient had permanent injury. Conclusion. The TOETVA is a safe and reproducible procedure. For selected patients, this technique is a viable alternative to conventional thyroidectomy.

Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.

Importance: The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. Objective: To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. Design, Setting, and Participants: Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016. Interventions: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. Main Outcomes and Measures: The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years. Results: Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. Conclusions and Relevance: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

Transoral endoscopic thyroidectomy vestibular approach with intraoperative nerve monitoring.

BACKGROUND: Transoral endoscopic thyroidectomy by a vestibular approach (TOETVA) is a novel technique for thyroid gland excision. Compared to the transaxillary endoscopic and bilateral axillo-breast approaches, which require substantial dissection to reach the thyroid gland, TOETVA provides the most direct access to the target organ. METHODS: The aim of this video is to provide a step-by-step overview of TOETVA and demonstrate how to set up and utilize intraoperative nerve monitoring. RESULTS: Three incisions are placed in the vestibular region of the oral cavity just below the lower lip for placement of 2 lateral 5-mm trocars and 1 centrally placed 11-mm trocar. Insufflation to 6 mm Hg is used to maintain the working spacing. Using a 2-handed technique and triangulation, the thyroid gland is mobilized, taking care to identify and preserve the relevant cervical anatomy. CONCLUSION: TOETVA is safe and feasible and provides an excellent cosmetic outcome with the most confidentially compared to the other remote access endoscopic approaches.

Genetic-epigenetic dysregulation of thymic TSH receptor gene expression triggers thyroid autoimmunity.

Graves disease (GD) is an autoimmune condition caused by interacting genetic and environmental factors. Genetic studies have mapped several single-nucleotide polymorphisms (SNPs) that are strongly associated with GD, but the mechanisms by which they trigger disease are unknown. We hypothesized that epigenetic modifications induced by microenvironmental influences of cytokines can reveal the functionality of GD-associated SNPs. We analyzed genome-wide histone H3 lysine 4 methylation and gene expression in thyroid cells induced by IFNα, a key cytokine secreted during viral infections, and overlapped them with known GD-associated SNPs. We mapped an open chromatin region overlapping two adjacent GD-associated SNPs (rs12101255 and rs12101261) in intron 1 of the thyroid stimulating hormone receptor (TSHR) gene. We then demonstrated that this region functions as a regulatory element through binding of the transcriptional repressor promyelocytic leukemia zinc finger protein (PLZF) at the rs12101261 site. Repression by PLZF depended on the rs12101261 disease susceptibility allele and was increased by IFNα. Intrathymic TSHR expression was decreased in individuals homozygous for the rs12101261 disease-associated genotype compared with carriers of the disease-protective allele. Our studies discovered a genetic-epigenetic interaction involving a noncoding SNP in the TSHR gene that regulates thymic TSHR gene expression and facilitates escape of TSHR-reactive T cells from central tolerance, triggering GD.

Objectively-measured sedentary time and cardiometabolic health in adults with severe obesity.

It is unknown whether sedentary behavior is independently associated with the cardiometabolic health of adults with severe obesity. Additionally, there is debate regarding how best to derive meaningful indices of sedentary time (ST) from activity monitor data. A convenience sample of adults with severe obesity (N=927; 79% female, median age 45y, median body mass index (BMI) 46kg/m(2)) completed a research assessment at one of ten US hospitals in 2006-2009 prior to bariatric surgery. Cardiometabolic health was assessed via physical measures, fasting blood samples and medication use. Indices of ST were derived from StepWatch™ activity monitor data with minimum bout durations of 1min, 10min and 30min. Cross-sectional associations were examined. Median (25th, 75th percentile) ST was 9.3h/d (8.1, 10.5) in ≥1min bouts, 6.5h/d (5.2, 8.0) in ≥10min bouts, or 3.2h/d (2.1, 4.5) in ≥30min bouts. Associations with ST were generally strongest with the ≥10min bout duration. Independent of moderate-to-vigorous intensity physical activity, BMI and other potential confounders, 1h/day ST in ≥10min bouts was associated with higher odds of diabetes by 15% (95%CI: 1.05-1.26), metabolic syndrome by 12% (95%CI: 1.01-1.24) and elevated blood pressure by 14% (95%CI: 1.02-1.26), and was associated with 1.4cm (95%CI: 0.9-1.9) larger waist circumference. Findings indicate the importance of considering ST as a distinct health risk among adults with severe obesity, and suggest a 10min minimum duration may be preferable to 1min or 30min for establishing ST from activity monitor data.

The Mount Sinai clinical pathway for the management of pheochromocytoma.

OBJECTIVE: Pheochromocytomas are complex tumors that require a comprehensive and systematic management plan orchestrated by a multidisciplinary team. METHODS: To achieve these ends, The Mount Sinai Adrenal Center hosted an interdisciplinary retreat where experts in adrenal disorders assembled with the aim of developing a clinical pathway for the management of pheochromocytomas. RESULTS: The result was a consensus for the diagnosis, perioperative management, and postoperative management of pheochromocytomas, with specific recommendations from our team of adrenal experts, as well as a review of the current literature. CONCLUSION: Our clinical pathway can be applied by other institutions directly or may serve as a guide for institution-specific management.

Expanding the indications for laparoscopic retroperitoneal adrenalectomy: experience with 81 resections.

BACKGROUND: Laparoscopic retroperitoneal (RP) adrenalectomy has gained popularity as the preferred approach over transabdominal (TA) method; however, surgeons have been reluctant to offer this operation to obese patients because of the concerns over inadequate working space and overall perceived higher rate of complications. The aim of the present study was to evaluate the feasibility and safety of RP adrenalectomy compared with TA adrenalectomy, specifically in morbidly obese patients. METHODS: All laparoscopic adrenalectomies performed at our institution between 2004 and 2012 were reviewed retrospectively. Presenting features, operative characteristics, and postoperative outcomes were evaluated. Complications were graded using Clavien system. Continuous variables were compared using Student t-test. Categorical variables were compared using χ(2)-test. Prediction models were constructed using linear or logistic regression as appropriate. RESULTS: Eighty-one RP and 130 TA procedures were performed, 26 (12.3%) and 60 (28.4%), respectively in obese patients (BMI > 30). Among the obese patients, operative time and estimated blood loss were less for RP (90 versus 130 min; P < 0.001 and 0 versus 50 mL; P < 0.001). Differences in the length of stay, overall mortality, incidence and severity of postoperative complications, and rates of readmission were not statistically significant between RP and TA procedures for all comers and in the obese patients. Controlling the operative characteristics and patient-specific factors, neither operative approach nor obesity was found to independently predict the postoperative complications. CONCLUSIONS: Laparoscopic RP adrenalectomy is a safe and feasible technique for obese patients. In the obese patients and for all comers, it offers shorter operative time, decreased estimated blood loss, with comparable length of stay and morbidity and mortality rates. We therefore recommend that this technique should be considered for patients undergoing adrenal resection.

Racial disparities in access to liver transplantation in patients with early-stage hepatocellular carcinoma.

BACKGROUND: Orthotopic liver transplantation is the recommended treatment option for patients with early-stage hepatocellular carcinoma and concomitant cirrhosis. Waitlist candidacy can be affected by social determinants of health that vary across races and ethnicities. Our study sought to evaluate whether racial/ethnic disparities exist in access to orthotopic liver transplantation in patients with hepatocellular carcinoma. METHODS: The National Cancer Database participant use file was used to analyze data between 2004 and 2020. Patients 18-70 years of age with TNM clinical stage I and II hepatocellular carcinoma who received either orthotopic liver transplantation or liver directed/nonsurgical therapies were included. Baseline demographic variables and treatment modalities were collected. Patients were assigned fixed categories on the basis of race and ethnicity. Descriptive statistics, multivariable logistical regressions, effects modification analysis, and propensity matching were used. RESULTS: There were 23,313 non-Hispanic White, 5,215 non-Hispanic Black, 5,581 Hispanic, and 2,768 other patients included in this analysis. Significant socioeconomic variation was observed across races. Non-Hispanic White patients were more likely to undergo orthotopic liver transplantation than non-Hispanic Black patients. The proportion of patients insured by Medicare was the same between non-Hispanic White and non-Hispanic Black patients. There was a graeter proportion of non-Hispanic Black patients with Medicaid compared with non-Hispanic White patients, whereas a lower proportion of non-Hispanic Black patients were insured via private insurance compared with non-Hispanic White patients. Effect modification analysis showed the non-Hispanic Black patients were less likely to undergo orthotopic liver transplantation for those with private and Medicare coverage compared with non-Hispanic White patients. Propensity matching showed a significantly decreased rate of orthotopic liver transplantation in non-Hispanic Black patients compared with non-Hispanic White patients. CONCLUSION: Non-Hispanic Black patients were less likely to undergo orthotopic liver transplantation for early-stage hepatocellular carcinoma, despite adjusting for cancer stage and socioeconomic factors, compared with non-Hispanic White patients. Social determinants of health were associated with the probability of undergoing orthotopic liver transplantation. Understanding disparities related to social determinants of health will help guide health policy changes and improved access to care.

Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.

IMPORTANCE: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. OBJECTIVE: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. DESIGN, SETTING, AND PARTICIPANTS: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. INTERVENTIONS: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. MAIN OUTCOMES AND MEASURES: Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. RESULTS: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. CONCLUSIONS AND RELEVANCE: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00641251.

Lobectomy or Total Thyroidectomy-Where Is the Pendulum now for Differentiated Thyroid Cancer?

Thyroid surgery remains an essential treatment of thyroid cancer. The historical one-size-fits-all approach to differentiated (papillary and follicular) thyroid carcinoma of total thyroidectomy with central lymph node dissection has been shown to be overtreatment with associated risk of perioperative complications including nerve palsy and hypoparathyroidism. Furthermore, thyroid lobectomy may obviate life-long thyroid hormone replacement. Low-risk thyroid cancers have a low risk of recurrence and those that do recur can be salvaged with reoperation without compromising prognosis. Perioperative risk stratification for recurrence and death greatly influence the need for total thyroidectomy.

Opioid-Free Thyroid and Parathyroid Operations: Are Patients Satisfied With Pain Control?

BACKGROUND: The aim of this study was to evaluate pain control and patient satisfaction using an opioid-free analgesic regimen following thyroid and parathyroid operations. METHODS: Surveys were distributed to all postoperative patients following total thyroidectomy, thyroid lobectomy, and parathyroidectomy between January and April 2020. After surgery, patients were discharged without opioids except in rare cases based on patient needs and surgeon judgment. We measured patient-reported Numeric Rating Scale (NRS) pain scores and satisfaction categorically as either satisfied or dissatisfied. RESULTS: We received 90 of 198 surveys distributed, for a 45.5% response rate. After excluding neck dissections (n = 6) and preoperative opioid use (n = 4), the final cohort included 80 patients after total thyroidectomy (26.3%), thyroid lobectomy (41.3%), and parathyroidectomy (32.5%).The majority reported satisfaction with pain control (87.5%) and the entire surgical experience (95%). A similar proportion of patients reported satisfaction with pain control after total thyroidectomy (90.9%), thyroid lobectomy (90.5%), and parathyroidectomy (80.8%), indicating the procedure did not significantly impact satisfaction with pain control (P = .47). Patients who reported dissatisfaction with pain control were more likely to receive opioid prescriptions (30% vs 2.9%, P < .01), but the majority still reported satisfaction with their entire operative experience (70%). DISCUSSION: Even with an opioid-free postoperative pain regimen, most patients report satisfaction with pain control after thyroid and parathyroid operations, and those who were dissatisfied with their pain control generally reported satisfaction with their overall surgical experience. Therefore, an opioid-free postoperative pain control regimen is well tolerated and unlikely to decrease overall patient satisfaction.

A comparison of NSQIP and CESQIP in data quality and ability to predict thyroidectomy outcomes.

BACKGROUND: The Collaborative Endocrine Surgery Quality Improvement Program tracks thyroidectomy outcomes with self-reported data, whereas the National Surgical Quality Improvement Program uses professional abstractors. We compare completeness and predictive ability of these databases at a single-center and national level. METHOD: Data consistency in the Collaborative Endocrine Surgery Quality Improvement Program and the National Surgical Quality Improvement Program at a single institution (2013-2020) was evaluated using McNemar's test. At the national level, data from the Collaborative Endocrine Surgery Quality Improvement Program and the National Surgical Quality Improvement Program (2016-2019) were used to compare predictive capability for 4 outcomes within each data source: thyroidectomy-specific complication, systemic complication, readmission, and reoperation, as measured by area under curve. RESULTS: In the single-center analysis, 66 cases were recorded in both the Collaborative Endocrine Surgery Quality Improvement Program and the National Surgical Quality Improvement Program. The reoperation variable had the most discrepancies (2 vs 0 in the National Surgical Quality Improvement Program versus the Collaborative Endocrine Surgery Quality Improvement Program, respectively; χ2 = 2.00, P = .16). At the national level, there were 24,942 cases in the National Surgical Quality Improvement Program and 17,666 cases in the Collaborative Endocrine Surgery Quality Improvement Program. In the National Surgical Quality Improvement Program, 30-day thyroidectomy-specific complication, systemic complication, readmission, and reoperation were 13.25%, 2.13%, 1.74%, and 1.39%, respectively, and in the Collaborative Endocrine Surgery Quality Improvement Program 7.27%, 1.95%, 1.64%, and 0.81%. The area under curve of the National Surgical Quality Improvement Program was higher for predicting readmission (0.721 [95% confidence interval 0.703-0.737] vs 0.613 [0.581-0.649]); the area under curve of the Collaborative Endocrine Surgery Quality Improvement Program was higher for thyroidectomy-specific complication (0.724 [0.708-0.737] vs 0.677 [0.667-0.687]) and reoperation (0.735 [0.692-0.775] vs 0.643 [0.611-0.673]). Overall, 3.44% vs 27.22% of values were missing for the National Surgical Quality Improvement Program and the Collaborative Endocrine Surgery Quality Improvement Program, respectively. CONCLUSION: The Collaborative Endocrine Surgery Quality Improvement Program was more accurate in predicting thyroidectomy-specific complication and reoperation, underscoring its role in collecting granular, disease-specific variables. However, a higher proportion of data are missing. The National Surgical Quality Improvement Program infrastructure leads to more rigorous data capture, but the Collaborative Endocrine Surgery Quality Improvement Program is better at predicting thyroid-specific outcomes.

Partial small bowel resection with sleeve gastrectomy increases adiponectin levels and improves glucose homeostasis in obese rodents with type 2 diabetes.

BACKGROUND: The aim of this study was to examine the effect of small bowel resection with and without sleeve gastrectomy on glucose homeostasis in an obese rodent model of type 2 diabetes. METHODS: Zucker diabetic fatty rats were randomized into three surgical groups: Sham, small bowel resection, and small bowel resection with sleeve gastrectomy (BRSG). Weight and fasting glucose levels were measured at randomization and monitored after surgery. Oral glucose tolerance testing was performed at baseline and 45 days after surgery to assess glucose homeostasis and peptide changes. RESULTS: At baseline, all animals exhibited impaired glucose tolerance and showed no difference in weight or fasting (area under the curve) AUC(glucose). At sacrifice, Sham animals weighed more than BRSG animals (p = 0.047). At day 45, the Sham group experienced a significant increase in AUC(glucose) compared to baseline (p = 0.02), whereas there was no difference in AUC(glucose) in either surgical group at any time point: BR (p = 0.58) and BRSG (p = 0.56). Single-factor ANOVA showed a significant difference in AUC(glucose) of p = 0.004 between groups postoperatively: Sham (50,745 ± 11,170) versus BR (23,865 ± 432.6) (p = 0.01); Sham versus BRSG (28,710 ± 3188.8) (p = 0.02). There was no difference in plasma insulin, GLP-1, or adiponectin levels before surgery, although 45 days following surgery adiponectin levels where higher in the BRSG group (p = 0.004). CONCLUSIONS: Partial small bowel resection improved glucose tolerance independent of weight. The combination of small bowel resection and sleeve gastrectomy leads to an increase in adiponectin levels, which may contribute to improved glucose homeostasis.

Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA).

PURPOSE: Selumetinib can increase radioactive iodine (RAI) avidity in RAI-refractory tumors. We investigated whether selumetinib plus adjuvant RAI improves complete remission (CR) rates in patients with differentiated thyroid cancer (DTC) at high risk of primary treatment failure versus RAI alone. METHODS: ASTRA (ClinicalTrials.gov identifier: NCT01843062) is an international, phase III, randomized, placebo-controlled, double-blind trial. Patients with DTC at high risk of primary treatment failure (primary tumor > 4 cm; gross extrathyroidal extension outside the thyroid gland [T4 disease]; or N1a/N1b disease with ≥ 1 metastatic lymph node(s) ≥ 1 cm or ≥ 5 lymph nodes [any size]) were randomly assigned 2:1 to selumetinib 75 mg orally twice daily or placebo for approximately 5 weeks (no stratification). On treatment days 29-31, recombinant human thyroid-stimulating hormone (0.9 mg)-stimulated RAI (131I; 100 mCi/3.7 GBq) was administered, followed by 5 days of selumetinib/placebo. The primary end point (CR rate 18 months after RAI) was assessed in the intention-to-treat population. RESULTS: Four hundred patients were enrolled (August 27, 2013-March 23, 2016) and 233 randomly assigned (selumetinib, n = 155 [67%]; placebo, n = 78 [33%]). No statistically significant difference in CR rate 18 months after RAI was observed (selumetinib n = 62 [40%]; placebo n = 30 [38%]; odds ratio 1.07 [95% CI, 0.61 to 1.87]; P = .8205). Treatment-related grade ≥ 3 adverse events were reported in 25/154 patients (16%) with selumetinib and none with placebo. The most common adverse event with selumetinib was dermatitis acneiform (n = 11 [7%]). No treatment-related deaths were reported. CONCLUSION: Postoperative pathologic risk stratification identified patients with DTC at high risk of primary treatment failure, although the addition of selumetinib to adjuvant RAI failed to improve the CR rate for these patients. Future strategies should focus on tumor genotype-tailored drug selection and maintaining drug dosing to optimize RAI efficacy.

Quality monitoring of microbial contamination of cryopreserved parathyroid tissue.

Cryopreservation of parathyroid tissue (PT) provides patients undergoing parathyroidectomy with an option for delayed autologous heterotopic parathyroid transplantation. A standard protocol for quality monitoring of PT has not been established. This article describes a method for detecting the presence of bacterial contamination in PT tissue intended for autologous transplantation. PT was received in the tissue bank, processed under aseptic conditions, and placed into cryopreservation medium. Sterility testing was performed at 2 time points prior to cryopreservation. From January 2005 to October 2008, 47 PT samples were cryopreserved. The following bacteria were isolated from 11 PT specimens: Staphylococcus epidermidis, Staphylococcus capitis subspecies ureolyticus, Staphylococcus lugdunensis, Bacillus pumilus, and corynebacteria (diphtheroids). 23% of PTs were contaminated at the time of collection, predominantly with indigenous bacteria. Quality monitoring using this protocol is a useful tool to identify tissues contaminated with bacteria.

Post-thyroidectomy emergency room visits and readmissions: Assessment from the Collaborative Endocrine Surgery Quality Improvement Program (CESQIP).

BACKGROUND: This study analyzed independent factors associated with post-thyroidectomy Emergency Room (ER) visits and Hospital Readmissions (HR). METHODS: This is a retrospective review from the CESQIP registry of 8381 thyroidectomy patients by 173 surgeons at 46 institutions. A total of 7142 ER visits and 7265 HR were analyzed. Multivariable logistic regression analysis was performed to determine the risk factors for an ER visit or HR. RESULTS: Within 30-days of surgery, rates of all ER visits were 3.4% (n = 250) and all HR were 2.3% (n = 170). Hypocalcemia was the reason for 21.9% of ER encounters and 36.4% of HR. BMI >40 kg/m2 was a risk factor for both ER visit (OR1.86) and HR (OR1.94). Surgical duration >3 h (OR2.63), and transection of recurrent laryngeal nerve (OR4.58) were risk factors for HR. CONCLUSIONS: Strategies to decrease hypocalcemia and improve perioperative care of patients with BMI >40 kg/m2 may improve post-thyroidectomy outcome.

A rodent model of metabolic surgery for study of type 2 diabetes and positron emission tomography scanning of beta cell mass.

BACKGROUND: Type 2 diabetes mellitus is a worldwide healthcare problem with major socioeconomic implications. Metabolic surgical procedures have been shown to improve diabetes, but the mechanism of action is poorly understood. The Goto-Kakizaki (GK) rodent is a type 2 diabetic animal model that is ideally situated for studying the effect of surgery on diabetes; however, the operative mortality is high. The aim of this study was to describe the operative technique, improvements in perioperative management, and the technique of micro-positron emission tomography (PET) scanning of the beta-cell mass in GK rodents. METHODS: A total of 53 GK rats were divided into 1 of 3 operative groups: sham, sleeve gastrectomy, and duodenojejunal bypass. A subset of animals underwent micro-PET scanning with [11C]-dihydrotetrabenazine to determine the vesicular monoamine transporter 2 binding index, an indicator of beta-cell mass. RESULTS: The 30-day mortality in the sham and sleeve gastrectomy rodents was 0; however, 2 sleeve gastrectomy rodents developed enterocutaneous fistula and 1 developed an abscess. In the duodenojejunal bypass group, the initial mortality rate was close to 90%; however, refinements in the surgical technique and perioperative management (fluids, antibiotics, pain control) lowered the mortality rate to 60%. The surgical technique is discussed in detail. [11C]-Dihydrotetrabenazine uptake in the pancreas was demonstrated on micro-PET scanning in the sham and duodenojejunal bypass rodents. CONCLUSION: Intensive medical management in the perioperative period and attention to the operative technique lowered the mortality. [11C]-Dihydrotetrabenazine micro-PET scanning is a feasible method for assessing the beta-cell mass in GK rodents and could prove to be an important modality for evaluating beta-cell performance in type 2 diabetes.