CA19-9 Normalization During Pre-operative Treatment Predicts Longer Survival for Patients with Locally Progressed Pancreatic Cancer

Background

Compared to the widely adopted 2–4 months of pre-operative therapy for patients with borderline resectable (BR) or locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC), our institution tends to administer a longer duration before considering surgical resection. Using this unique approach, the aim of this study was to determine pre-operative variables associated with survival.

Methods

Records from patients with BR/LA PDAC who underwent attempt at surgical resection from 1992–2014 were reviewed.

Results

After a median duration of 6 months of pre-operative treatment, 109 patients with BR/LA PDAC (BR 63, LA 46) were explored; 93 (85.3 %) underwent pancreatectomy. Those who received at least 6 months of pre-operative treatment had longer median overall survival (OS) than those who received less (52.8 vs. 32.1 months, P?=?0.044). On multivariate analysis, pre-operative treatment duration was the strongest predictor of survival (hazard ratio (HR) 4.79, P?=?0.043). However, OS was similar in those whose CA19-9 normalized regardless of whether they received more or less than 6 months of chemotherapy (71.4 vs. 101.8 months, P?=?0.930).

Conclusions

Pre-operative CA19-9 decline can guide treatment duration in patients with BR/LA PDAC. We endorse 6 months of therapy except in those patients whose values normalize, where surgery can be considered after a shorter course.

     

Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study

Background

Endoscopic gastric balloons have been used effectively as weight loss devices for decades, but the requirement for endoscopy and sedation poses several limitations. The goal of this pilot study was to evaluate the safety and performance of a prototype version of Elipse?, a procedureless gastric balloon.

Methods

Eight patients (mean BMI?=?31.0 kg/m²) participated in this study. Each patient swallowed one Elipse? balloon intended to remain in the stomach for 6 weeks, self-empty, and then pass. Each balloon was filled with 450 mL of filling fluid. Patients returned every 2 weeks for abdominal ultrasound. No specific diet or exercise plan was prescribed.

Results

All eight patients successfully swallowed the device. The most common adverse events were nausea and vomiting. There were no serious adverse events, and all balloons were excreted safely. Despite not being prescribed a diet or exercise plan, all eight patients lost weight. In 6/8 patients, the balloon remained full through 6 weeks, self-emptied, and passed. In one patient, the balloon appeared partially collapsed on ultrasound after 11 days and was endoscopically punctured. One asymptomatic patient elected to have the balloon endoscopically punctured after 19 days. Both balloons passed in the stool after 4 days. In both cases, endoscopic examination of the upper GI tract showed no abnormalities.

Conclusions

This pilot study demonstrates the safety and performance of Elipse?, a procedureless gastric balloon for weight loss. Future studies will test a commercial design filled to 550 mL intended to last in the stomach for at least 12 weeks.

     

FGF 19 and Bile Acids Increase Following Roux-en-Y Gastric Bypass but Not After Medical Management in Patients with Type 2 Diabetes

Background

This study aims to quantify changes in fibroblast growth factor 19 (FGF19) and bile acids (BAs) in patients with uncontrolled type 2 diabetes randomized to Roux-en-Y gastric bypass (RYGB) vs intensive medical management (IMM) and matched for similar reduction in HbA1c after 1 year of treatment.

Methods

Blood samples were drawn from patients who underwent a test meal challenge before and 1 year after IMM (n?=?15) or RYGB (n?=?15).

Results

Mean HbA1c decreased from 9.7 to 6.4 % after RYGB and from 9.1 to 6.1 % in the IMM group. At 12 months, the number of diabetes medications used per subject in the RYGB group (2.5?±?0.5) was less than in the IMM group (4.6?±?0.3). After RYGB, FGF19 increased in the fasted (93?±?15 to 152?±?19 pg/ml; P?=?0.008) and postprandial states (area under the curve (AUC), 10.8?±?1.9 to 23.4?±?4.1 pg?×?h/ml?×?10³; P?=?0.006) but remained unchanged following IMM. BAs increased after RYGB (AUC ×10³, 6.63?±?1.3 to 15.16?±?2.56 μM?×?h; P?=?0.003) and decreased after IMM (AUC ×10³, 8.22?±?1.24 to 5.70?±?0.70; P?=?0.01). No changes were observed in the ratio of 12α-hydroxylated/non-12α-hyroxylated BAs. Following RYGB, FGF19 AUC correlated with BAs (r?=?0.54, P?=?0.04) and trended negatively with HbA1c (r?=??0.44; P?=?0.09); these associations were not observed after IMM.

Conclusions

BA and FGF19 levels increased after RYGB but not after IMM in subjects who achieved similar improvement in glycemic control. Further studies are necessary to determine whether these hormonal changes facilitate improved glucose homeostasis.

     

Predictors of Excess Weight Loss in Obese Patients After Gastric Bypass: a 60-Month Follow-up

Background

The objective of this study was to analyze the factors associated with change in body mass index (BMI) and with percentage of excess weight loss (%EWL) in patients undergoing Roux-en-Y gastric bypass (RYGB). The following factors were analyzed: sex, age, surgical access (laparotomy vs. laparoscopy), preoperative BMI, waist circumference (WC), type 2 diabetes mellitus (T2DM), high blood pressure, and dyslipidemia.

Methods

Retrospective cohort study using a convenience sample of 2070 patients of both sexes, aged 18 to 65 years, undergoing RYGB between 2000 and 2013. The outcomes of interest were BMI and %EWL at 0, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after RYGB.

Results

After 36, 48, and 60 months, approximately 50 % of patients had BMI >30 kg/m². As for %EWL, 60-month results were poor for 17 % of patients (%EWL <50 %), good for 40 % of patients (%EWL 50–75 %), very good for 24 % of patients (%EWL from >75–90 %), and excellent for 19 % of patients (%EWL >90 %). The four most significant predictors of BMI change 60 months after RYGB (in descending order of magnitude) were preoperative BMI, preoperative WC, surgical access, and age; and of %EWL, surgical access, preoperative BMI, preoperative WC, and age.

Conclusions

After 60 months of follow-up, the most relevant predictors of weight loss after RYGB were lower preoperative BMI and WC, videolaparoscopy as surgical access, and younger age. Further studies must be carried out to elucidate the impact of these factors on RYGB outcomes.

     

Perception and Awareness of Bariatric Surgery in Canada: a National Survey of General Surgeons

Background

The objective of this study was to assess Canadian general surgeons’ knowledge of bariatric surgery and perceived availability of resources to manage bariatric surgery patients.

Methods

A self-administered questionnaire was developed using a focus group of general surgeons. The questionnaire was distributed at two large general surgery conferences in September and November 2012. The survey was also disseminated via membership association electronic newsletters in November and December 2012.

Results

One hundred sixty-seven questionnaires were completed (104 practicing surgeons, 63 general surgery trainees). Twenty respondents were bariatric surgeons. Among 84 non-bariatric surgeons, 68.3 % referred a patient in the last year for bariatric surgery, 79 % agreed that bariatric surgery resulted in sustained weight loss, and 81.7 % would consider referring a family member. Knowledge gaps were identified in estimates of mortality and morbidity associated with bariatric procedures. The majority of surgeons surveyed have encountered patients with complications from bariatric surgery in the last year. Over 50 % of surgeons who do not perform bariatric procedures reported not feeling confident to manage complications, 35.4 % reported having adequate resources and equipment to manage morbidly obese patients, and few are able to transfer patients to a bariatric center. Of the respondents, 73.3 % reported residency training provided inadequate exposure to bariatric surgery, and 85.3 % felt that additional continuing medical education resources would be useful.

Conclusions

There appears to be support for bariatric surgery among Canadian general surgeons participating in this survey. Knowledge gaps identified indicate the need for more education and resources to support general surgeons managing bariatric surgical patients.

     

The Effect of Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients on Pharmacokinetics of (Acetyl)Salicylic Acid and Omeprazole: the ERY-PAO Study

Background

Data on the absorption of orally administered drugs following Roux-en-Y gastric bypass (RYGB) surgery in obese patients are limited and inconclusive. As it is difficult to predict changes in absorption, studies on frequently used drugs in this population are necessary. Acetylsalicylic acid (ASA) and omeprazole are two commonly prescribed drugs in obese patients.

Methods

In this repeated measures study, omeprazole and salicylic acid (SA) serum concentrations were measured before and after RYGB in 34 morbidly obese subjects. Time to maximum concentration (Tmax), lag time (Tlag), maximum concentration (Cmax), and area under the serum concentration versus time curve (AUC) were calculated for both drugs to determine possible differences in drug absorption after the procedure.

Results

For SA, Tmax significantly decreased after RYGB, while both Cmax and AUC_0–24 significantly increased. For omeprazole, both Tmax and Tlag significantly decreased after RYGB, while Cmax significantly increased. Mean AUC_0–12 significantly decreased post-surgery. The difference in AUC_0–12 before and after surgery varied between subjects.

Conclusions

Our study shows a faster absorption of both ASA and omeprazole after RYGB. The exposure to ASA is higher post-surgery, but the standard dose of 80 mg does not need to be modified, considering its range in effective dose. The exposure to omeprazole is, on average, decreased after surgery. Clinicians should be aware to increase the dose of omeprazole if symptoms suggest inadequate response.

     

A Pre-Hospital Patient Education Program Improves Outcomes of Bariatric Surgery

Background

We designed an assessment and education program which was delivered to patients prior to first outpatient appointment for bariatric surgery. We hypothesised that this program would streamline care and would lead to improved weight loss following bariatric surgery.

Methods

The program incorporates a structured general practitioners (GP) review, a patient information evening and an on-line learning package. It was introduced in September 2012. Patient flow through the program was recorded. Outcomes of the new program were compared with contemporaneously treated patients who did not undertake the pre-hospital program.

Results

All 636 patients on the waiting list for first appointment at the Alfred Health bariatric surgery clinic were invited to participate. There were 400 patients ultimately removed from the waiting list for first appointment. Of the remaining 236 patients, 229 consented to participate in the new program. The mean BMI was 47.8?±?9.2. The fail to attend first appointment rate dropped from 12 to 2.1 %. At 12 months post-bariatric surgery, patients who undertook the new program (n?=?82) had a mean excess weight loss (EWL) of 41.1?±?20.3 % where as those treated on the standard pathway (n?=?61) had a mean EWL 32?±?18.0 % (p?=?0.012).

Conclusions

The introduction of a pre-hospital education program has led to an improvement in attendance rates and early weight loss post-bariatric surgery.

     

Maximizing Weight Loss After Roux-en-Y Gastric Bypass May Decrease Risk of Incident Organ Cancer

Background

Recent studies have suggested that metabolic surgery reduces cancer risk. This study aims to determine if incident cancer is associated with the extent of weight loss after Roux-en-Y gastric bypass (RYGB).

Methods

Patients at a large tertiary bariatric surgery center were retrospectively reviewed to identify patients with no history of cancer at the time of RYGB. Diagnoses in the electronic health record, a tumor registry, and chart review were used to identify postoperative incident solid organ cancer. The overall incidence of organ cancer was estimated using Kaplan-Meier analysis. The percent total body weight loss (%TWL) in the 48 months after surgery but prior to cancer was compared between those that developed organ cancer versus those that did not using repeated measures linear regression.

Results

The 2943 patients had a mean age of 45.6 years (SD?=?11.1), 81 % were female, and a mean baseline body mass index (BMI) of 47.2 kg/m² (SD?=?7.9). Median follow-up after surgery was 3.8 years (range?=?[<1, 12]). Incident organ cancer developed and was verified in 54 of the 2943 patients (1.8 %). Kaplan-Meier estimates for cancer at 3, 5, and 10 years postsurgery were 1.3, 2.5, and 4.2 %. After adjusting for age, BMI, sex, diabetes, hypertension, and dyslipidemia, patients that developed organ cancer achieved less weight loss (?1.5 % TWL, 95 % CI?=?[?2.9 %, ?0.1 %], p?=?0.034).

Conclusions

Greater weight loss after metabolic surgery may be associated with lower organ cancer risk.

     

Implementing a robotics curriculum at an academic general surgery training program: our initial experience

The robotic surgical platform is being utilized by a growing number of hospitals across the country, including academic medical centers. Training programs are tasked with teaching their residents how to utilize this technology. To this end, we have developed and implemented a robotic surgical curriculum, and share our initial experience here. Our curriculum was implemented for all General Surgical residents for the academic year 2014–2015. The curriculum consisted of online training, readings, bedside training, console simulation, participating in ten cases as bedside first assistant, and operating at the console. 20 surgical residents were included. Residents were provided the curriculum and notified the department upon completion. Bedside assistance and operative console training were completed in the operating room through a mix of biliary, foregut, and colorectal cases. During the fiscal years of 2014 and 2015, there were 164 and 263 robot-assisted surgeries performed within the General Surgery Department, respectively. All 20 residents completed the online and bedside instruction portions of the curriculum. Of the 20 residents trained, 13/20 (65 %) sat at the Surgeon console during at least one case. Utilizing this curriculum, we have trained and incorporated residents into robot-assisted cases in an efficient manner. A successful curriculum must be based on didactic learning, reading, bedside training, simulation, and training in the operating room. Each program must examine their caseload and resident class to ensure proper exposure to this platform.