Endoscopic ultrasound-guided liver palpation as a screening tool for advanced fibrosis and cirrhosis in patients with suspected metabolic dysfunction-associated steatotic liver disease: a pilot study.

BACKGROUND AND AIMS: Endoscopic liver "palpation" can be performed by indenting the liver surface under endoscopic ultrasound (EUS). Indentation depth is measured with the use of sonographic calipers. We hypothesized that fibrotic livers are more difficult to indent, and that indentation can accurately predict liver fibrosis staging. We compared EUS-guided liver palpation and conventional screening modalities in patients with suspected metabolic dysfunction-associated steatotic liver disease. METHODS: This was a cross-sectional pilot study. Consecutive patients at 3 hospitals from 2021 to 2023 underwent EUS-guided palpation with liver biopsy. Liver palpation was compared with fibrosis-4 index (FIB-4), aspartate transaminase to platelet ratio index (APRI), nonalcoholic fatty liver disease fibrosis score (NFS), and transient elastography in predicting fibrosis staging on histology. Area under the receiver operating characteristic curve analysis was performed. RESULTS: Seventy-three patients were included. Mean age was 49.1 years, and 71.2% were female. Mean body mass index was 41.1 kg/m.2 Indentation depth was negatively correlated with fibrosis stage (Kruskal-Willis test, P < .0001). EUS palpation demonstrated c-statistics of 0.79 and 0.95 in discriminating advanced fibrosis and cirrhosis, respectively. EUS liver palpation was superior to NFS in predicting advanced fibrosis (P = .0057) and superior to APRI and NFS in predicting cirrhosis (P = .0099 and P = .045, respectively). EUS palpation was not significantly different from FIB-4. EUS palpation was superior to transient elastography in predicting cirrhosis (P = .045). When optimal cutoffs were used, indentation measurement ≤3.5 mm yielded 100% predictive value for ruling in advanced fibrosis, and ≥4.0 mm yielded 100% predictive value for ruling out cirrhosis. CONCLUSIONS: EUS liver palpation is a novel, accurate, and easy-to-use screening tool for advanced fibrosis and cirrhosis in patients with metabolic dysfunction-associated steatotic liver disease.

Magnetic cholecysto-duodenal anastomosis.

INTRODUCTION: There is a growing interest in minimally invasive endoscopic gallbladder drainage therapies. Unlike stenting, a technology based on magnetic compression could theoretically produce a durable drainage anastomosis without residual foreign material. This study aimed to evaluate the safety and technical feasibility of a cholecysto-duodenal magnetic compression anastomosis. MATERIAL AND METHODS: We performed a survival study of two Yorkshire pigs. Duodenal magnets were deployed endoscopically; reciprocal gallbladder magnets were placed laparoscopically, and the magnets were coupled. Pigs underwent serial endoscopy documenting magnet expulsion and evolution of cholecysto-duodenal anastomosis creation. Necropsies and histological evaluation were performed. Primary endpoints were technical success and safety. Secondary endpoints included anastomosis integrity, patency, and histologic characteristics. RESULTS: Magnets were successfully delivered and coupled. Patent, leak-free anastomoses formed by day 4. Magnets were expelled by day 10. All anastomoses were widely patent at one month (mean diameter 15 mm). Necropsy showed the absence of adhesions affecting the anastomosis. Histology showed complete re-epithelialization without inflammation or foreign body reaction. CONCLUSIONS: Magnetic cholecysto-duodenal anastomosis for gallbladder drainage appears safe and feasible in the animal model. The anastomoses are patent, leak-free, and without inflammation from the presence of foreign material. Technical modifications for magnet delivery under endoscopic ultrasound (EUS) guidance are currently underway.

Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in patients with obesity and diabetes.

BACKGROUND AND AIMS: Most patients with type 2 diabetes mellitus have obesity. Studies show that bariatric surgery is superior to medical treatment for remission of type 2 diabetes mellitus. Nevertheless, very few patients undergo surgery, and a less-invasive endoscopic alternative is desirable. METHODS: This was a single-arm first-in-human pilot study designed to evaluate the technical feasibility, safety, and clinical performance of the incisionless magnetic anastomosis system (IMAS) to create a partial jejunal diversion (PJD). Ten patients with obesity and type 2 diabetes mellitus, prediabetes, or no diabetes were enrolled. A PJD to the ileum was attempted in all patients under general anesthesia. The IMAS was delivered through the working channel of a colonoscope, with laparoscopic supervision. The patients were not required to participate in an intensive lifestyle/diet management program. Endoscopic visualization of the anastomosis was obtained at 2, 6, and 12 months. Patient weight, glycemic profile, and metabolic panels were acquired at 0.5, 1, 2, 3, 6, 9, and 12 months. RESULTS: A PJD was created in all patients with no device-related serious adverse events. The anastomosis remained widely patent in all patients at 1 year. Average total weight loss was 14.6% (40.2% excess weight loss at 12 months). A significant reduction in glycated hemoglobin level was observed in all diabetic (1.9%) and prediabetic (1.0%) patients, while reducing or eliminating the use of diabetes medications. CONCLUSIONS: Permanent anastomosis for PJD was created in all patients with the IMAS. This resulted in improvement in measures of hyperglycemia and progressive weight loss. (Clinical trial registration number: NCT02839512.).

Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery.

BACKGROUND & AIMS: Weight regain or insufficient loss after Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss after sutured transoral outlet reduction (TORe). METHODS: Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. RESULTS: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage weight loss in the TORe group than controls (3.9% and 0.2%, respectively; P = .014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P = .019). The TORe group had reduced systolic and diastolic blood pressure (P < .001) and a trend toward improved metabolic indices. In addition, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events. CONCLUSIONS: A multicenter randomized trial provides Level I evidence that TORe reduces weight regain after RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results. ClinicalTrials.gov identifier: NCT00394212.

Phase II trial of vaccination with autologous, irradiated melanoma cells engineered by adenoviral mediated gene transfer to secrete granulocyte-macrophage colony stimulating factor in patients with stage III and IV melanoma.

Background: In the era of immune checkpoint blockade, the role of cancer vaccines in immune priming has provided additional potential for therapeutic improvements. Prior studies have demonstrated delayed type hypersensitivity and anti-tumor immunity with vaccines engineered to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF). The safety, efficacy and anti-tumor immunity of GM-CSF secreting vaccine in patients with previously treated stage III or IV melanoma needs further investigation. Methods: In this phase II trial, excised lymph node metastases were processed to single cells, transduced with an adenoviral vector encoding GM-CSF, irradiated, and cryopreserved. Individual vaccines were composed of 1x106, 4x106, or 1x107 tumor cells, and were injected intradermally and subcutaneously at weekly and biweekly intervals. The primary endpoints were feasibility of producing vaccine in stage III patients and determining the proportion of patients alive at two years in stage IV patients. Results: GM-CSF vaccine was successfully developed and administered in all 61 patients. Toxicities were restricted to grade 1-2 local skin reactions. The median OS for stage III patients (n = 20) was 71.1 (95% CI, 43.7 to NR) months and 14.9 (95%CI, 12.1 to 39.7) months for stage IV patients. The median PFS in stage III patients was 50.7 (95%CI, 36.3 to NR) months and 4.1 (95% CI, 3.0-6.3) months in stage IV patients. In the overall population, the disease control rate was 39.3% (95%CI, 27.1 to 52.7%). In stage III patients, higher pre-treatment plasma cytokine levels of MMP-1, TRAIL, CXCL-11, CXCL-13 were associated with improved PFS (p<0.05 for all). An increase in post-vaccination levels of IL-15 and TRAIL for stage III patients was associated with improved PFS (p=0.03 for both). Similarly, an increase in post-vaccination IL-16 level for stage IV patients was associated with improved PFS (p=0.02) and clinical benefit. Conclusions: Vaccination with autologous melanoma cells secreting GM-CSF augments antitumor immunity in stage III and IV patients with melanoma, is safe, and demonstrates disease control. Luminex data suggests that changes in inflammatory cytokines and immune cell infiltration promote tumor antigen presentation and subsequent tumor cell destruction. Additional investigation to administer this vaccine in combination with immune checkpoint inhibitors is needed.

Endoscopic sclerotherapy for the treatment of weight regain after Roux-en-Y gastric bypass: outcomes, complications, and predictors of response in 575 procedures.

BACKGROUND: Weight regain after Roux-en-Y gastric bypass (RYGB) is common. Endoscopic sclerotherapy is increasingly used to treat this weight regain. OBJECTIVES: To report safety, outcomes, durability, and predictors of response to sclerotherapy in a large prospective cohort. DESIGN: Retrospective analysis of a prospective cohort study of patients with weight regain after RYGB. PATIENTS: A total of 231 consecutive patients undergoing 575 sclerotherapy procedures between September 2008 and March 2011. INTERVENTIONS: Single or multiple sclerotherapy procedures to inject sodium morrhuate into the rim of the gastrojejunal anastomosis. MAIN OUTCOME MEASUREMENTS: We report weight loss, complications, and predictors of response. We also used Kaplan-Meier survival analysis and log-rank test to compare time to continuation of weight regain after sclerotherapy in patients undergoing a single versus multiple sclerotherapy procedures. RESULTS: At 6 and 12 months from the last sclerotherapy procedure, weight regain stabilized in 92% and 78% of the cohort, respectively. Those who underwent 2 or 3 sclerotherapy sessions had significantly higher rates of weight regain stabilization than those who underwent a single session (90% vs 60% at 12 months; P = .003). The average weight loss at 6 months from the last sclerotherapy session for the entire cohort was 10 lb (standard deviation 16), representing 18% of the weight regained after RYGB. A subset of 73 patients (32% of the cohort) had greater weight loss at 6 months (26 lb, standard deviation 12), representing 61% of the weight regained. Predictors of a favorable outcome included greater weight regain and the number of sclerotherapy procedures. Bleeding was reported in 2.4% of procedures and transient diastolic blood pressure increases in 15%, without adverse health outcomes. No GI perforations were reported. CONCLUSIONS: Endoscopic sclerotherapy appears to be a safe and effective tool for the management of weight regain after RYGB.

Gastrojejunal stoma diameter predicts weight regain after Roux-en-Y gastric bypass.

BACKGROUND & AIMS: Weight regain after Roux-en-Y gastric bypass (RYGB) is associated with reductions in health status and quality of life. We evaluated whether gastrojejunal stoma diameter is a risk factor for weight regain after RYGB. METHODS: We examined data collected over 4 years from consecutive patients referred to a tertiary care bariatric center for upper endoscopy after RYGB. We used linear regression analysis to determine the association between the gastrojejunal stoma diameter and weight regain. We applied a logistic regression model using clinical and endoscopic parameters to develop a prediction rule for weight gain after RYGB. RESULTS: Among 165 patients included in our study, 59% had significant weight regain (≥ 20% of maximum weight lost after the RYGB) and 41% did not. The mean percentage of maximal weight lost after RYGB that was regained in the entire cohort was 30% ± 22%. Gastrojejunal stoma diameter was associated significantly with weight regain after RYGB surgery in univariate analysis (ß = .31, P < .0001). This association remained significant after adjusting for several known or purported risk factors for weight regain (ß = .19, P = .003). We developed a simple prediction rule for weight regain after RYGB using a 7-point scoring system that includes the gastrojejunal stoma diameter, race, and percentage of maximal body weight lost after RYGB; a cut-off score of 4 or more points had an area under receiver operating characteristic curve of 0.76 and a positive predictive value of 75%. CONCLUSIONS: Increased gastrojejunal stoma diameter is a risk factor for weight regain after RYGB and can be incorporated in a novel prediction rule.

Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patients.

Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) functions as a negative regulator of endogenous and vaccine-induced antitumor immunity. The administration of fully human anti-CTLA-4 blocking monoclonal antibodies to advanced-cancer patients increases immune-mediated tumor destruction in some subjects. Nonetheless, patients that respond also frequently manifest serious inflammatory pathologies, raising the possibility that the therapeutic and toxic effects of CTLA-4 blockade might be linked. Here we show that periodic infusions of anti-CTLA-4 antibodies after vaccination with irradiated, autologous tumor cells engineered to secrete GM-CSF (GVAX) generate clinically meaningful antitumor immunity without grade 3 or 4 toxicity in a majority of metastatic melanoma patients. The application of this sequential immunotherapy to advanced ovarian carcinoma patients also revealed that tumor destruction and severe inflammatory pathology could be dissociated, although further refinements are required to increase clinical responses and to minimize toxicity in this population. The extent of therapy-induced tumor necrosis was linearly related to the natural logarithm of the ratio of intratumoral CD8(+) effector T cells to FoxP3(+) regulatory T cells (Tregs) in posttreatment biopsies. Together, these findings help clarify the immunologic and clinical effects of CTLA-4 antibody blockade in previously vaccinated patients and raise the possibility that selective targeting of antitumor Tregs may constitute a complementary strategy for combination therapy.

Sutureless Duodeno-Ileal Anastomosis with Self-Assembling Magnets: Safety and Feasibility of a Novel Metabolic Procedure.

BACKGROUND: Less invasive and safer anastomotic techniques are desirable. We aimed to determine technical feasibility and safety of sutureless duodeno-ileal side-to-side anastomosis in obese patients using self-assembling magnets. METHODS: This was an open-label, prospective, and single-arm study including obese patients (BMI 30-50 kg/m2) with type II diabetes. The ileal magnet was deployed laparoscopically, and the duodenal magnet was deployed endoscopically. Both magnets were coupled under laparoscopic and fluoroscopic guidance. The primary endpoints were technical feasibility and safety. The secondary endpoints were patency of the anastomosis, HbA1c reduction, and weight loss 12 months after the procedure. RESULTS: A total of 8 patients were enrolled in the study; median age was 51.5 years (range: 34-65), and median BMI was 38.8 kg/m2 (range: 35-47.9). The mean procedural duration was 63.5 min (range: 41-95). No intraoperative complications were recorded, and no major postoperative morbidity related to the procedure occurred. Magnets were expelled at a median of 29.5 days after the procedure with no associated complications. Upper endoscopy at 12 months confirmed patent anastomoses with healthy-appearing mucosa in all patients. HbA1c reduced below 7.0% in 6 out of 8 (75%) patients, and greater than 5% of total body weight loss was observed in 7 out of 8 (87.5%) patients at 12 months. CONCLUSIONS: Sutureless duodeno-ileal side-to-side anastomosis using self-assembling magnets is feasible and safe in obese patients, and a dual-path enteral diversion with large-caliber and durable anastomosis can be achieved.

Treatment of weight regain after gastric bypass surgery when using a new endoscopic platform: initial experience and early outcomes (with video).

BACKGROUND: Some patients are thought to regain weight after gastric bypass surgery because of dilation of the gastrojejunal anastomosis (GJA) and/or gastric pouch. OBJECTIVE: To assess the technical success and safety of an endoscopic procedure, Revision Obesity Surgery Endoscopic (ROSE), using an endoscopic operating system for the placement of tissue anchors to reduce the diameter of the GJA and size of the gastric pouch. DESIGN: Prospective case series. SETTING: Brigham and Women's Hospital, Boston, Massachusetts. PATIENTS AND INTERVENTIONS: A total of 20 patients who had regained a mean of 13 kg after gastric bypass, with a dilated pouch and GJA on screening endoscopy, underwent the ROSE procedure. MAIN OUTCOME MEASUREMENTS: Technical success, reduction in size of the GJA and gastric pouch, and early complications. Early weight loss was also assessed. RESULTS: Technical success was achieved in 17 of 20 (85%) patients with an average reduction in stoma diameter of 16 mm (65% reduction) and an average reduction in pouch length of 2.5 cm (36% reduction). The mean weight loss in successful cases was 8.8 kg at 3 months. There were no major complications. LIMITATIONS: Single-center case series with a relatively small number of patients and short duration of follow-up, which was inadequate for assessing durable long-term weight loss. CONCLUSION: The ROSE procedure is technically feasible and appears safe. Data from this series suggest that the ROSE procedure is effective in reducing not only the size of the GJA but also the gastric pouch and may provide an endoscopic alternative for weight regain in gastric bypass patients.

Perioperative nursing care of the bariatric surgical patient.

APPROXIMATELY TWO-THIRDS of the US population is overweight or obese. The effects of the comorbidities that accompany obesity often are severe and can be life threatening over time. Currently, the most effective and sustainable method of substantial weight loss is bariatric surgery. Bariatric surgery also has been successful in reversing comorbidities. THE BENEFITS, RISKS, AND COMPLICATIONS of common weight-loss surgical procedures (eg, Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, vertical-banded gastroplasty, biliopancreatic diversion and duodenal switch) are discussed. THE HEALTH CARE FIELD OF BARIATRICS is growing rapidly. More information is needed to support and guide changes in current standards of practice to better meet the needs of this patient population.

Pathophysiology of obesity: why surgery remains the most effective treatment.

Obesity is a rapidly increasing, worldwide epidemic. Despite recent scientific advances, no currently recommended dietary program or medication results in long-term weight loss of more than 10% of body weight for the vast majority of people who attempt these interventions. Hence, surgical intervention is recommended for patients with a BMI > or =40 kg/m2. Although surgery is an effective, sustainable treatment of obesity, it can be associated with potentially significant perioperative risks and long-term complications. Current research is focused on developing a medical therapy, which produces more effective and sustainable weight loss, yet avoids the risks inherent in major surgery. With a reduced risk profile, such therapy could also be appropriately offered to those who are less obese and, in theory, help those who have BMIs as low as 27 kg/m2. Toward that end, numerous scientists are working to both unravel the pathophysiology of obesity and to determine why surgical intervention is so effective. This review briefly examines the current status of obesity pathophysiology and management, the reasons for failure of conventional medical treatments, and the success of surgical intervention. Finally, future areas of research are discussed.

Bariatric operations in Veterans Affairs and selected university medical centers: results of the patient safety in surgery study.

BACKGROUND: The objectives of this study were to evaluate outcomes and predictors of morbidity in patients undergoing Roux-en-Y gastric bypass (RYGB) during the Patient Safety in Surgery (PSS) Study. STUDY DESIGN: National Surgical Quality Improvement Program data on PSS patients undergoing RYGB were analyzed for unadjusted and adjusted outcomes. Gender groups acted differently and were analyzed separately. Multivariable regression modeling was used to analyze hospital type as a predictor of risk. Stepwise logistic regression was performed to determine patient factors predictive of postoperative morbidity. RESULTS: A total of 2,438 patients (2,064 private sector [PS], 374 Veterans Affairs [VA]) were identified for analysis. Adjusted odds ratio for postoperative morbidity for VA versus PS female patients was 1.14 (95% CI, 0.63-2.05), and for male patients 2.29 (95% CI, 1.28-4.10). Stepwise logistic regression showed that independent risk factors predictive of morbidity were open procedure, higher American Society of Anesthesiologists class, higher body mass index, diabetes, alcohol consumption, leukocytosis, SGOT > 40 U/L, smoking history, and older age. Importantly, male gender was not significant (p = 0.13) in the regression analysis. Subsequent and unrelated to this study, the VA has restructured its bariatric surgical program, including regionalization of centers, with a substantial lowering of associated mortality and morbidity. CONCLUSIONS: The VA male subset showed higher risk-adjusted postoperative morbidity compared with the PS male subset. The VA and PS female subsets had equivalent risk-adjusted postoperative morbidity. A systematic approach to quality-improvement processes resulted in improved bariatric surgical outcomes in the VA. Male gender might not be an independent risk factor in RYGB patients.

Insulinoma After Bariatric Surgery: Diagnostic Dilemma and Therapeutic Approaches.

Hypoglycemia is increasingly recognized as a complication of bariatric surgery. Typically, hypoglycemia does not appear immediately postoperatively, but rather more than 1 year later, and usually occurs 1-3 h after meals. While rare, insulinoma has been reported after bariatric surgery. Clinical factors which should raise suspicion for insulinoma and the need for comprehensive clinical and biochemical evaluation include hypoglycemia occurring in the fasting state, predating bariatric surgery, and/or worsening immediately postoperatively, and lack of response to conservative therapy. Localization and successful resection of insulinoma can be achieved using novel endoscopic ultrasound and surgical approaches. In summary, hypoglycemia presenting shortly after gastric bypass or with a dominant fasting pattern should be fully evaluated to exclude insulinoma. Additionally, evaluation prior to gastric bypass should include screening for history of hypoglycemia symptoms.

Effect of vagotomy during Roux-en-Y gastric bypass surgery on weight loss outcomes.

BACKGROUND: During Roux-en-Y gastric bypasses (RYGB), some surgeons elect to perform a vagotomy to reduce symptoms of gastro-oesophageal reflux (GER). Routine vagotomy during RYGB may independently affect weight loss and metabolic outcomes following bariatric surgery. We aimed to determine whether vagotomy augments percent excess weight loss in obese patients after RYGB. METHODS: We examined the effect of vagotomy in 1278 patients undergoing RYGB at our institution from 2003 to 2009. Weight and percent excess weight loss (%EWL) were modelled at three months and annually up to five years using a longitudinal linear mixed model controlling for differences in age, gender, initial body mass index (BMI), ideal body weight, and presence of vagotomy. RESULTS: Vagotomy was performed on 40.3% of our cohort. Vagotomy patients had significantly lower initial BMI (46.4±6.2 vs. 48.3±7.7kg/m(2), p<0.001), but there were no other significant differences at baseline. The strongest predictor of %EWL over time was initial BMI, with lower BMI patients exhibiting greater %EWL (p<0.001). Age and gender effects were also significant, with younger patients (p<0.04) and males (p<0.002) attaining greater %EWL. Vagotomy had no effect on %EWL in either simple or multiple regression models. CONCLUSION: Our series suggest that vagotomy does not augment %EWL when performed with RYGB.

Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

CONTEXT: Recommendations for surgical, compared with lifestyle and pharmacologically based, approaches for type 2 diabetes (T2D) management remain controversial. OBJECTIVE: The objective was to compare laparoscopic adjustable gastric band (LAGB) to an intensive medical diabetes and weight management (IMWM) program for T2D. DESIGN: This was designed as a prospective, randomized clinical trial. SETTING: The setting was two Harvard Medical School-affiliated academic institutions. INTERVENTIONS AND PARTICIPANTS: A 12-month randomized trial comparing LAGB (n = 23) vs IMWM (n = 22) in persons aged 21-65 years with body mass index of 30-45 kg/m(2), T2D diagnosed more than 1 year earlier, and glycated hemoglobin (HbA(1c)) ≥ 6.5% on antihyperglycemic medication(s). MAIN OUTCOME MEASURE: The proportion meeting the prespecified primary glycemic endpoint, defined as HbA(1c) < 6.5% and fasting glucose < 7.0 mmol/L at 12 months, on or off medication. RESULTS: After randomization, five participants did not undergo the surgical intervention. Of the 40 initiating intervention (22 males/18 females; age, 51 ± 10 y; body mass index, 36.5 ± 3.7 kg/m(2); diabetes duration, 9 ± 5 y; HbA(1c), 8.2 ± 1.2%; 40% on insulin), the proportion meeting the primary glycemic endpoint was achieved in 33% of the LAGB patients and 23% of the IMWM patients (P = .457). HbA(1c) reduction was similar between groups at both 3 and 12 months (-1.2 ± 0.3 vs -1.0 ± 0.3%; P = .496). Weight loss was similar at 3 months but greater 12 months after LAGB (-13.5 ± 1.7 vs -8.5 ± 1.6 kg; P = .027). Systolic blood pressure reduction was greater after IMWM than LAGB, whereas changes in diastolic blood pressure, lipids, fitness, and cardiovascular risk scores were similar between groups. Patient-reported health status, assessed using the Short Form-36, Impact of Weight on Quality of Life, and Problem Areas in Diabetes, all improved similarly between groups. CONCLUSIONS: LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control, cardiometabolic risk, and patient satisfaction, which should be considered in the context of other factors, such as personal preference, when selecting treatment options with obese T2D patients. Longer duration studies are important to understand emergent differences.

Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial.

IMPORTANCE: Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. OBJECTIVE: To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS: A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A1c (HbA1c) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. INTERVENTIONS: RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. MAIN OUTCOMES AND MEASURES: Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. RESULTS: At 1 year, the proportion of patients achieving HbA1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA1c, weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. CONCLUSIONS AND RELEVANCE: In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01073020.

Implementing a bariatric surgery program.

The number of people who are obese or morbidly obese is increasing in the United States. Currently, the most effective means of losing a substantial amount of weight and maintaining the weight loss is bariatric surgery, and health care providers, especially those in surgical services, must be able to safely care for patients undergoing these surgeries. Financial implications of starting a bariatric surgery program and the ongoing costs must be fully understood and supported by both administrators and employees. Special equipment and supplies are needed to handle the higher weight of bariatric patients, and careful planning is required for adequate medical and nursing expertise, staffing, equipment, supplies, facility resources, and patient support services.

Laparoscopic adjustable gastric banding and hypoglycemia.

Obesity is commonplace, and surgical treatment usually includes Roux-en-Y gastric bypasses (RYGBs). RYGBs have the most documented side effects including vitamin deficiencies, rebound weight gain, and symptomatic hypoglycemia; fewer series exist describing hypoglycemia following other bariatric operations. We reviewed all patients undergoing laparoscopic adjustable gastric banding (LAGB) at our institution between 2008 and 2012. Three patients were identified to have symptomatic hypoglycemia following LAGB. Mean time from surgery was 33 months (range 14-45 months), and mean weight loss was 32.7 kg (range 15.9-43.1 kg). None of the patients had preexisting diabetes. Therefore, symptomatic hypoglycemia should be investigated irrespective of bariatric operation.

Resection or reduction? The dilemma of managing retrograde intussusception after Roux-en-Y gastric bypass.

BACKGROUND: Retrograde intussusception (RI) at the jejunojejunostomy can occur after Roux-en-Y gastric bypass (RYGB). Although this complication is rare, it has been encountered more frequently as the number of bariatric procedures have increased. Little data is available to assist surgeons with the optimal management of this condition. Our objectives were to identify the risk factors for RI after RYGB and report on outcomes after surgical intervention at a tertiary academic surgical unit. METHODS: We used our prospective longitudinal institutional bariatric surgical database to identify patients with post-RYGB RI from 1996 to 2011. RESULTS: We identified 28 post-RYGB RI cases. The median interval between RYGB and RI was 52 months, and the median percentage of excess weight loss was 75%. Patients presented with acute symptoms in 36% of the cases. All patients underwent surgical exploration, including resection and revision of the jejunojejunostomy (46%) or operative reduction with or without enteropexy (54%). Those undergoing resection had a longer hospital stay but similar 30-day complication rates. At a median follow-up of 9 months, only 1 recurrence was documented. CONCLUSIONS: RI is a rare and late complication of RYGB and typically occurs after significant weight loss. In the presence of ischemia or nonreducible RI, resection and revision of the jejunojejunostomy is recommended. In less acute patients, laparoscopic management with reduction and/or enteropexy offers a reduced hospital length of stay while maintaining equivalent morbidity and low recurrence compared with resection.