Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss, Comorbidities, and Reflux at 10 Years in Adult Patients With Obesity: The SLEEVEPASS Randomized Clinical Trial.

Importance: Long-term results from randomized clinical trials comparing laparoscopic sleeve gastrectomy (LSG) with laparoscopic Roux-en-Y-gastric bypass (LRYGB) are limited. Objective: To compare long-term outcomes of weight loss and remission of obesity-related comorbidities and the prevalence of gastroesophageal reflux symptoms (GERD), endoscopic esophagitis, and Barrett esophagus (BE) after LSG and LRYGB at 10 years. Design, Setting, and Participants: This 10-year observational follow-up evaluated patients in the Sleeve vs Bypass (SLEEVEPASS) multicenter equivalence randomized clinical trial comparing LSG and LRYGB in the treatment of severe obesity in which 240 patients aged 18 to 60 years with median body mass index of 44.6 were randomized to LSG (n = 121) or LRYGB (n = 119). The initial trial was conducted from April 2008 to June 2010 in Finland, with last follow-up on January 27, 2021. Interventions: LSG or LRYGB. Main Outcomes and Measures: The primary end point was 5-year percentage excess weight loss (%EWL). This current analysis focused on 10-year outcomes with special reference to reflux and BE. Results: At 10 years, of 240 randomized patients (121 randomized to LSG and 119 to LRYGB; 167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline BMI, 45.9 [6.0]), 2 never underwent surgery and there were 10 unrelated deaths; 193 of the remaining 228 patients (85%) completed follow-up on weight loss and comorbidities, and 176 of 228 (77%) underwent gastroscopy. Median (range) %EWL was 43.5% (2.1%-109.2%) after LSG and 50.7% (1.7%-111.7%) after LRYGB. Mean estimate %EWL was not equivalent between the procedures; %EWL was 8.4 (95% CI, 3.1-13.6) higher in LRYGB. After LSG and LRYGB, there was no statistically significant difference in type 2 diabetes remission (26% and 33%, respectively; P = .63), dyslipidemia (19% and 35%, respectively; P = .23), or obstructive sleep apnea (16% and 31%, respectively; P = .30). Hypertension remission was superior after LRYGB (8% vs 24%; P = .04). Esophagitis was more prevalent after LSG (31% vs 7%; P < .001) with no statistically significant difference in BE (4% vs 4%; P = .29). The overall reoperation rate was 15.7% for LSG and 18.5% for LRYGB (P = .57). Conclusions and Relevance: At 10 years, %EWL was greater after LRYGB and the procedures were not equivalent for weight loss, but both LSG and LRYGB resulted in good and sustainable weight loss. Esophagitis was more prevalent after LSG, but the cumulative incidence of BE was markedly lower than in previous trials and similar after both procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT00793143.

Effect of Laparoscopic Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass on Weight Loss and Quality of Life at 7 Years in Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

Importance: Laparoscopic sleeve gastrectomy (LSG) is currently the predominant bariatric procedure, although long-term weight loss and quality-of-life (QoL) outcomes compared with laparoscopic Roux-en-Y gastric bypass (LRYGB) are lacking. Objective: To determine weight loss equivalence of LSG and LRYGB at 7 years in patients with morbid obesity, with special reference to long-term QoL. Design, Setting, and Participants: The SLEEVE vs byPASS (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted between March 10, 2008, and June 2, 2010, in Finland. The trial enrolled 240 patients with morbid obesity aged 18 to 60 years who were randomized to undergo either LSG or LRYGB with a 7-year follow-up (last follow-up, September 26, 2017). Analysis was conducted on an intention-to-treat basis. Statistical analysis was performed from June 4, 2018, to November 8, 2019. Interventions: Laparoscopic sleeve gastrectomy (n = 121) or LRYGB (n = 119). Main Outcomes and Measures: The primary end point was percentage excess weight loss (%EWL) at 5 years. Secondary predefined follow-up time points were 7, 10, 15, and 20 years, with included 7-year secondary end points of QoL and morbidity. Disease-specific QoL (DSQoL; Moorehead-Ardelt Quality of Life questionnaire [range of scores, -3 to 3 points, where a higher score indicates better QoL]) and general health-related QoL (HRQoL; 15D questionnaire [0-1 scale for all 15 dimensions, with 1 indicating full health and 0 indicating death]) were measured preoperatively and at 1, 3, 5, and 7 years postoperatively concurrently with weight loss. Results: Of 240 patients (167 women [69.6%]; mean [SD] age, 48.4 [9.4] years; mean [SD] baseline body mass index, 45.9 [6.0]), 182 (75.8%) completed the 7-year follow-up. The mean %EWL was 47% (95% CI, 43%-50%) after LSG and 55% (95% CI, 52%-59%) after LRYGB (difference, 8.7 percentage units [95% CI, 3.5-13.9 percentage units]). The mean (SD) DSQoL total score at 7 years was 0.50 (1.14) after LSG and 0.49 (1.06) after LRYGB (P = .63), and the median HRQoL total score was 0.88 (interquartile range [IQR], 0.78-0.95) after LSG and 0.87 (IQR, 0.78-0.95) after LRYGB (P = .37). Greater weight loss was associated with better DSQoL (r = 0.26; P < .001). At 7 years, mean (SD) DSQoL scores improved significantly compared with baseline (LSG, 0.50 [1.14] vs 0.10 [0.94]; and LRYGB, 0.49 [1.06] vs 0.12 [1.12]; P < .001), unlike median HRQoL scores (LSG, 0.88 [IQR, 0.78-0.95] vs 0.87 [IQR, 0.78-0.90]; and LRYGB, 0.87 [IQR, 0.78-0.92] vs 0.85 [IQR, 0.77-0.91]; P = .07). The overall morbidity rate was 24.0% (29 of 121) for LSG and 28.6% (34 of 119) for LRYGB (P = .42). Conclusions and Relevance: This study found that LSG and LRYGB were not equivalent in %EWL at 7 years. Laparoscopic Roux-en-Y gastric bypass resulted in greater weight loss than LSG, but the difference was not clinically relevant based on the prespecified equivalence margins. There was no difference in long-term QoL between the procedures. Bariatric surgery was associated with significant long-term DSQoL improvement, and greater weight loss was associated with better DSQoL. Trial Registration: ClinicalTrials.gov Identifier: NCT00793143.

Physical Activity Associates with Muscle Insulin Sensitivity Postbariatric Surgery.

PURPOSE: Bariatric surgery is considered as an effective therapeutic strategy for weight loss in severe obesity. Remission of type 2 diabetes is often achieved after the surgery. We investigated whether increase in self-reported habitual physical activity associates with improved skeletal muscle insulin sensitivity and reduction of fat depots after bariatric surgery. METHODS: We assessed self-reported habitual physical activity using Baecke questionnaire in 18 diabetic and 28 nondiabetic patients with morbid obesity (median age, 46 yr; body mass index, 42.0 kg·m) before and 6 months after bariatric surgery operation. Insulin-stimulated femoral muscle glucose uptake was measured using fluorodeoxyglucose positron emission tomography method during hyperinsulinemia. In addition, abdominal subcutaneous and visceral fat masses were quantified using magnetic resonance imaging and liver fat content using magnetic resonance spectroscopy. Also, serum proinflammatory cytokines were measured. RESULTS: Patients lost on average 22.9% of weight during the follow-up period of 6 months (P < 0.001). Self-reported habitual physical activity level increased (P = 0.017). Improvement in skeletal muscle insulin sensitivity was observed only in those patients who reported increase in their physical activity postoperatively (P = 0.018). The increase in self-reported physical activity associated with the loss of visceral fat mass (P = 0.029). Postoperative self-reported physical activity correlated also positively with postoperative hepatic insulin clearance (P = 0.02) and tended to correlate negatively with liver fat content (P = 0.076). Postoperative self-reported physical activity also correlated negatively with serum TNFα, methyl-accepting chemotaxis protein and interleukin 6 levels. CONCLUSIONS: Self-reported physical activity is associated with reversal of skeletal muscle insulin resistance after bariatric surgery as well as with the loss of visceral fat content and improved postoperative metabolism in bariatric surgery patients. TRIAL REGISTRATION: Clinicaltrials.gov, NCT00793143 (SLEEVEPASS), NCT01373892 (SLEEVEPET2).

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss at 5 Years Among Patients With Morbid Obesity: The SLEEVEPASS Randomized Clinical Trial.

Importance: Laparoscopic sleeve gastrectomy for treatment of morbid obesity has increased substantially despite the lack of long-term results compared with laparoscopic Roux-en-Y gastric bypass. Objective: To determine whether laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass are equivalent for weight loss at 5 years in patients with morbid obesity. Design, Setting, and Participants: The Sleeve vs Bypass (SLEEVEPASS) multicenter, multisurgeon, open-label, randomized clinical equivalence trial was conducted from March 2008 until June 2010 in Finland. The trial enrolled 240 morbidly obese patients aged 18 to 60 years, who were randomly assigned to sleeve gastrectomy or gastric bypass with a 5-year follow-up period (last follow-up, October 14, 2015). Interventions: Laparoscopic sleeve gastrectomy (n = 121) or laparoscopic Roux-en-Y gastric bypass (n = 119). Main Outcomes and Measures: The primary end point was weight loss evaluated by percentage excess weight loss. Prespecified equivalence margins for the clinical significance of weight loss differences between gastric bypass and sleeve gastrectomy were -9% to +9% excess weight loss. Secondary end points included resolution of comorbidities, improvement of quality of life (QOL), all adverse events (overall morbidity), and mortality. Results: Among 240 patients randomized (mean age, 48 [SD, 9] years; mean baseline body mass index, 45.9, [SD, 6.0]; 69.6% women), 80.4% completed the 5-year follow-up. At baseline, 42.1% had type 2 diabetes, 34.6% dyslipidemia, and 70.8% hypertension. The estimated mean percentage excess weight loss at 5 years was 49% (95% CI, 45%-52%) after sleeve gastrectomy and 57% (95% CI, 53%-61%) after gastric bypass (difference, 8.2 percentage units [95% CI, 3.2%-13.2%], higher in the gastric bypass group) and did not meet criteria for equivalence. Complete or partial remission of type 2 diabetes was seen in 37% (n = 15/41) after sleeve gastrectomy and in 45% (n = 18/40) after gastric bypass (P > .99). Medication for dyslipidemia was discontinued in 47% (n = 14/30) after sleeve gastrectomy and 60% (n = 24/40) after gastric bypass (P = .15) and for hypertension in 29% (n = 20/68) and 51% (n = 37/73) (P = .02), respectively. There was no statistically significant difference in QOL between groups (P = .85) and no treatment-related mortality. At 5 years the overall morbidity rate was 19% (n = 23) for sleeve gastrectomy and 26% (n = 31) for gastric bypass (P = .19). Conclusions and Relevance: Among patients with morbid obesity, use of laparoscopic sleeve gastrectomy compared with use of laparoscopic Roux-en-Y gastric bypass did not meet criteria for equivalence in terms of percentage excess weight loss at 5 years. Although gastric bypass compared with sleeve gastrectomy was associated with greater percentage excess weight loss at 5 years, the difference was not statistically significant, based on the prespecified equivalence margins. Trial Registration: clinicaltrials.gov Identifier: NCT00793143.

Accuracy of 18F-FDG PET/CT, Multidetector CT, and MR Imaging in the Diagnosis of Pancreatic Cysts: A Prospective Single-Center Study.

UNLABELLED: Accurate diagnosis of the nature of pancreatic cysts is challenging but more important than ever, in part because of the increasing number of incidental cystic findings in the pancreas. Preliminary data suggest that (18)F-FDG PET/CT may have a significant influence on clinical decision making, although its role is still evolving. Our aim was to prospectively compare the accuracy of combined (18)F-FDG PET and contrast-enhanced CT ((18)F-FDG PET/CT), multidetector CT (MDCT), and MR imaging in differentiating malignant from benign pancreatic cysts. METHODS: Thirty-one consecutive patients with pancreatic cysts were enrolled in the study. They underwent a protocol including (18)F-FDG PET/CT, MDCT, and MR imaging combined with MR cholangiopancreatography, all of which were evaluated in a masked manner. The findings were confirmed macroscopically at surgery or histopathologic analysis (n = 22) or at follow-up (n = 9). RESULTS: Of the 31 patients, 6 had malignant and 25 had benign lesions. The diagnostic accuracy was 94% for (18)F-FDG PET/CT, compared with 77% and 87% for MDCT (P < 0.05) and MR imaging, respectively. (18)F-FDG PET/CT had a negative predictive value of 100% and a positive predictive value of 75% for pancreatic cysts. The maximum standardized uptake value was significantly higher in malignant (7.4 ± 2.6) than in benign lesions (2.4 ± 0.8) (P < 0.05). When the maximum standardized uptake value was set at 3.6, the sensitivity and specificity were 100% and 88%, respectively. Furthermore, when compared with MDCT and MR imaging, respectively, (18)F-FDG PET/CT altered the clinical management of 5 and 3 patients, respectively. CONCLUSION: (18)F-FDG PET/CT is an accurate imaging modality for differentiating between benign and malignant pancreatic cysts. We recommend the use of (18)F-FDG PET/CT in the evaluation of diagnostically challenging pancreatic cysts.

Obesity-associated intestinal insulin resistance is ameliorated after bariatric surgery.

AIMS/HYPOTHESIS: The intestine is the main site for glucose absorption and it has been suggested that it exhibits insulin resistance. Bariatric surgery has been shown to reverse insulin resistance and type 2 diabetes, but its effects on human intestinal metabolism are unknown. Our aim was to evaluate the effects of insulin on intestinal glucose metabolism before and after bariatric surgery. METHODS: Twenty-one morbidly obese individuals undergoing bariatric surgery and ten age-matched healthy individuals were recruited and intestinal and skeletal muscle glucose uptake (GU) was measured using [(18)F]fluoro-2-deoxyglucose and positron emission tomography at fast and during hyperinsulinaemia. MRI was used as anatomical reference. Obese participants were studied again 6 months postoperatively. RESULTS: In contrast to healthy individuals, insulin had no effect on intestinal GU in obese participants with or without diabetes, suggesting that intestinal insulin resistance is present early in morbid obesity. Postoperatively, jejunal GU increased in line with whole-body and muscle GU. Postoperative GU values in the intestine correlated with whole-body insulin sensitivity, indicating that the intestinal mucosa may reflect the overall glycaemic state and potentially mediate obesity-associated insulin resistance. CONCLUSIONS/INTERPRETATION: This study shows that insulin is a potent stimulator of GU in the healthy intestine and that intestinal insulin resistance is ameliorated after bariatric surgery. In our study, obese individuals had intestinal insulin resistance regardless of their glycaemic status. Persistent changes in intestinal glucose metabolism are likely to influence both local processes in the gut and systemic glucose homeostasis.

Weight loss after bariatric surgery reverses insulin-induced increases in brain glucose metabolism of the morbidly obese.

Obesity and insulin resistance are associated with altered brain glucose metabolism. Here, we studied brain glucose metabolism in 22 morbidly obese patients before and 6 months after bariatric surgery. Seven healthy subjects served as control subjects. Brain glucose metabolism was measured twice per imaging session: with and without insulin stimulation (hyperinsulinemic-euglycemic clamp) using [18F]fluorodeoxyglucose scanning. We found that during fasting, brain glucose metabolism was not different between groups. However, the hyperinsulinemic clamp increased brain glucose metabolism in a widespread manner in the obese but not control subjects, and brain glucose metabolism was significantly higher during clamp in obese than in control subjects. After follow-up, 6 months postoperatively, the increase in glucose metabolism was no longer observed, and this attenuation was coupled with improved peripheral insulin sensitivity after weight loss. We conclude that obesity is associated with increased insulin-stimulated glucose metabolism in the brain and that this abnormality can be reversed by bariatric surgery.

Characterization of hepatic tumors using [11C]metomidate through positron emission tomography: comparison with [11C]acetate.

BACKGROUND: Using positron emission tomography (PET), we compared two tracers, [11C]metomidate ([11C]MTO) and [11C]acetate ([11C]ACE), for the characterization of hepatic tumors. METHODS: Thirty-three patients underwent PET with [11C]MTO and [11C]ACE and magnetic resonance imaging (MRI). Based on the histology of the tumor biopsy, 14 patients had hepatocellular carcinoma (HCC), 9 patients had focal nodular hyperplasia (FNH), and 10 patients had other types of hepatic tumors. Tumor uptake was evaluated by calculating the maximum and mean standardized uptake value and tumor-to-liver ratio. RESULTS: Altogether, 120 hepatic lesions (59 HCC, 18 FNH, 30 metastases of different primaries, 9 adenomas, and 4 regenerating nodules of liver cirrhosis) were detected by MRI. The overall tumor detection rate was slightly higher for [11C]MTO (39%) than for [11C]ACE (33%). [11C]ACE was more sensitive for HCC detection (50% versus 43%, respectively), whereas [11C]MTO was more sensitive for FNH detection (78% versus 44%, respectively). In HCC patients, the tumor grade correlated with [11C]ACE, but not with [11C]MTO. All of the patients with liver metastases, from various primary tumors (n = 10), were negative for both tracers. CONCLUSIONS: Due to low sensitivity, [11C]MTO and [11C]ACE PET have only limited value in diagnosing hepatic tumors.

SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results.

BACKGROUND: The long-term efficacy of laparoscopic Roux-en-Y gastric bypass (RYGB) in the treatment of morbid obesity has been demonstrated. Laparoscopic sleeve gastrectomy (SG) as a single procedure has shown promising short-term results, but the long-term efficacy of SG has not yet been demonstrated. The aim of this study was to determine the preliminary 30-day morbidity and mortality of RYGB and SG in a prospective multicenter randomized setting. METHODS: A total of 240 morbidly obese (BMI = 35-66 kg/m²) patients evaluated by a multidisciplinary team were randomized to undergo either RYGB or SG. There were 117 patients in the RYGB group and 121 in the SG group; two patients had to be excluded after randomization. Both study groups were comparable regarding age, gender, BMI, and comorbidities. RESULTS: There was no 30-day mortality. The median operating time was significantly shorter in the SG group (66 min vs. 94 min, p < 0.001). All complications were recorded thoroughly. There were 7 (5.8 %) major complications following SG and 11 (9.4 %) after RYGB (p = 0.292). Nine (7.4 %) SG patients and 20 (17.1 %) RYGB patients had minor complications (p = 0.023). The overall morbidity was 13.2 % after SG and 26.5 % after RYGB (p = 0.010). There were three (2.5 %) early reoperations after SG and four (3.3 %) after RYGB (p = 0.719). CONCLUSIONS: At 30-day analysis SG is associated with a shorter operating time and fewer early minor complications compared to RYGB. There were no significant differences in major complications or early reoperations. Long-term follow-up is required to determine the effect on weight loss, resolution of obesity-related comorbidities, and improvement of quality of life.

Fifteen-year outcome of laparoscopic and open Nissen fundoplication: a randomized clinical trial.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) has become the method of choice in the surgical treatment of gastroesophageal reflux disease (GERD), replacing its open counterpart without confirmation by the long-term results of controlled clinical studies. The goal of the present study was to compare the 15-year outcome of a randomized controlled comparison study of LNF versus open Nissen fundoplication (ONF). METHODS: From 1992 to 1995, 110 consecutive patients were randomized to undergo LNF or ONF. The 15-year objective results were evaluated by endoscopy, and the subjective symptomatic outcome was assessed by interviews. RESULTS: A total of 86 patients (48 in the LNF [LAP] and 38 in the ONF [OPEN] group) participated in the study. The late long-term symptomatic outcome was similar in the two patient groups. In the LAP group, 91.7% of the patients gave a positive evaluation of their surgical result, as compared with 76.3% of the patients in the OPEN group (p=0.0484). A significantly greater number of disrupted plications (p=0.0115) and incisional hernias (p<0.001) occurred in the OPEN than in the LAP group. Both the subjective outcome and the objective endoscopic and clinical findings in the present study were in accord with our previously reported outcomes at 11-years after laparoscopic versus open fundoplication. The study found a trend toward (p=0.0851) an increasing need for the regular use of a proton pump inhibitor with the passage of time after Nissen fundoplication. CONCLUSIONS: The 15-year results obtained in the present study define laparoscopic Nissen fundoplication as the procedure of choice in the surgical management of GERD. The long-term symptomatic outcomes of open and laparoscopic Nissen fundoplication appear to remain unaltered after the first 10 postoperative years.

A 5-year prospective quality of life analysis following laparoscopic adjustable gastric banding for morbid obesity.

BACKGROUND: In addition to actual weight loss and the possible resolution of obesity-related co-morbidities following bariatric surgery, another widely recognized important outcome measure is the improvement of quality of life (QOL). METHODS: Disease-specific quality of life (DSQOL) and general health-related quality of life (HRQOL) were measured preoperatively and at 1 and 5 years postoperatively following laparoscopic adjustable gastric banding (LAGB) for morbid obesity. The Moorehead-Ardelt questionnaire was used for DSQOL assessments and a generic 15-dimensional questionnaire (15D) was used for HRQOL measurements. In addition, HRQOL was compared with that of the age- and gender-standardized general population. RESULTS: DSQOL scores were significantly improved on all domains after 1 year from the operation and this improvement was maintained at 5 years. This improvement was also seen in the total HRQOL scores. Despite this improvement, the HRQOL after LAGB remained worse compared to the age- and gender-standardized general population. CONCLUSIONS: DSQOL and HRQOL improve both significantly after LAGB. This QOL improvement is maintained at 5-year follow-up although QOL does not reach the level of the general population.

Heterotopic gastric mucosal patch in patients with reflux laryngitis: an entity of clinical interest?

Heterotopic gastric mucosal patch (HGMP) in the upper esophagus has been suggested to play a role in the pathogenesis of laryngopharyngeal reflux. The aim of this study was to evaluate the prevalence and possible clinical significance of HGMPs in patients who underwent laparoscopic Nissen fundoplication for gastroesophageal reflux disease-induced reflux laryngitis.Forty consecutive patients with pH-proven reflux laryngitis referred to surgery by a specialist in otorhinolaryngology underwent laparoscopic Nissen fundoplication between 1998 and 2002. Twenty-seven (67.5%) of these patients underwent a postoperative upper gastrointestinal endoscopy paying special attention for detecting possible HGMPs in the proximal esophagus. When HGMP was found, biopsies were taken for histologic confirmation. A small histologically confirmed HGMP was detected in 1 out of 27 patients (3.7%). The prevalence of HGMPs in the upper esophagus in this specific patient group operated on for gastroesophageal reflux disease-induced reflux laryngitis equals the reported general prevalence rates of HGMPs detected in patients referred for upper gastrointestinal endoscopy as a part of gastrointestinal tract evaluation. The role of at least small HGMPs in the proximal esophagus in the pathogenesis of laryngopharyngeal reflux is clinically insignificant.

A prospective diagnostic accuracy study of 18F-fluorodeoxyglucose positron emission tomography/computed tomography, multidetector row computed tomography, and magnetic resonance imaging in primary diagnosis and staging of pancreatic cancer.

OBJECTIVE: To prospectively compare the accuracy of combined positron emission tomography/computed tomography using F-fluorodeoxyglucose (FDG-PET/CT), multidetector row computed tomography (MDCT), and magnetic resonance imaging (MRI) in the evaluation of patients with suspected pancreatic malignancy. SUMMARY BACKGROUND DATA: FDG-PET/CT imaging is increasingly used for staging of pancreatic cancer. Preliminary data suggest a significant influence of FDG-PET/CT on treatment planning, although its role is still evolving. METHODS: Thirty-eight consecutive patients with suspicion of pancreatic malignancy were enrolled. Patients underwent a protocol including FDG-PET/CT, MDCT, and MRI combined with magnetic resonance cholangiopancreatography, all of which were blindly evaluated. The findings were confirmed macroscopically at operation and/or by histopathologic analysis (n = 29) or follow-up (n = 9). Results of TNM classification of different imaging methods were compared with clinical TNM classification. RESULTS: Pancreatic adenocarcinoma was diagnosed in 17 patients, neuroendocrine tumor in 3, mass-forming pancreatitis in 4, cystic lesion in 6, and fibrosis in 2. Six patients had a finding of a normal pancreas. The diagnostic accuracy of FDG-PET/CT for pancreatic malignancy was 89%, compared with 76% and 79% for MDCT and MRI, respectively. In the differential diagnosis of suspected malignant biliary stricture at endoscopic retrograde cholangiopancreaticography (n = 21), FDG-PET/CT had a positive predictive value of 92%. In 17 patients with advanced pancreatic adenocarcinoma, FDG-PET/CT had a sensitivity of 30% for N- and 88% for M-staging. Both MDCT and MRI had sensitivities of 30% for N- and 38% for M-staging. Furthermore, the clinical management of 10 patients (26%) was altered after FDG-PET/CT. CONCLUSION: FDG-PET/CT was more sensitive than conventional imaging in the diagnosis of both primary pancreatic adenocarcinoma and associated distant metastases. In contrast, the sensitivity of FDG-PET/CT was poor in detecting local lymph node metastasis, which would have been important for an assessment of resectability. We recommend the use of FDG-PET/CT in the evaluation of diagnostically challenging cases, especially in patients with biliary strictures without evidence of malignancy in conventional imaging.

Decreased blood flow with increased metabolic activity: a novel sign of pancreatic tumor aggressiveness.

PURPOSE: To study blood flow (BF) and metabolism in normal pancreas and in different pancreatic lesions. We then determined the effect of these biomarkers on outcome in patients with pancreatic cancer. EXPERIMENTAL DESIGN: Oxygen-15-labeled water and fluorodeoxyglucose positron emission tomography/computed tomography scans were used in 26 patients with a suspicion of pancreatic cancer to measure pancreatic BF and metabolism. In addition, the ratio of standardized uptake value to BF (SUV/BF) was calculated. Patients were divided into three groups: patients with a finding of normal pancreas (n = 7), benign lesions (n = 8), and malignant tumors (n = 11). RESULTS: Patients with benign and malignant pancreatic tumors had decreased BF of the lesion by 48% and 60%, respectively, compared with patients with normal pancreatic tissue. SUV(max) was 3-fold higher in malignant tumors compared with both benign lesions and normal pancreas (P < 0.05). In contrast, the SUV(max) of patients with benign lesions and normal pancreas did not differ. The SUV/BF ratio was significantly higher in malignant lesions than in benign lesions or in patients with normal pancreas (P < 0.05). In patients with cancer, high SUV/BF ratio was a stronger predictor of poor survival compared with high metabolism or lower-than-normal pancreatic BF. CONCLUSIONS: BF in pancreatic cancer is significantly reduced compared with the normal pancreas, which may in part explain the poor success of both radiotherapy and chemotherapy. We suggest that the composite measurement of BF and metabolism in pancreatic cancer could serve as a novel tool in the planning of treatments targeting vasculature.

The clinical value of [18F]fluoro-dihydroxyphenylalanine positron emission tomography in primary diagnosis, staging, and restaging of neuroendocrine tumors.

The study was set up to determine the clinical value of dihydroxyphenylalanine positron emission tomography-computed tomography ([(18)F]DOPA PET-CT) in patients with neuroendocrine tumors (NETs). Eighty-two patients with suspected/known NET were imaged with PET(-CT) using [(18)F]DOPA. Patients were divided into two groups: primary diagnosis/staging and restaging of disease. All patients without previous diagnosis of NET had biochemical proof of disease. The diagnostic accuracy of PET was assessed by comparing the histopathology and clinical follow-up. The overall accuracy of [(18)F]DOPA PET was 90%. In patients having PET for primary diagnosis/staging (n=32), the accuracy of PET was 88%, and for restaging 92% (n=61). The mean s.d. sizes of primary and metastatic lesions detected by PET were 26+/-11 and 16+/-9 mm respectively. In organ-region-specific analysis, the sensitivity and specificity were 100% in the primary diagnosis of pheochromocytoma (n=16) and metastases were found in all cases with recurrent disease (n=5). The accuracy for NET of gastrointestinal tract was 92% in restaging (n=24). For the NETs located in the head-neck-thoracic region (n=19), the overall accuracy of PET was 89% including 12 cases of recurrent medullary thyroid cancer with a sensitivity of 90%. In analysis of patients with biochemical proof of disease combined with negative conventional imaging methods, PET had positive and negative predictive value of 92% and 95% respectively. [(18)F]DOPA PET-CT provided important additional information in the diagnosis of pheochromocytoma and restaging of known NET. Both in primary diagnosis and in patients with formerly known NET and increasing tumor markers, [(18)F]DOPA PET-CT is a sensitive first-line imaging method.

Subjective results and symptomatic outcome after fundoplication revision.

OBJECTIVE: In a small proportion of patients, fundoplication fails and a reoperation is required. However, there are few reports on the symptomatic outcome after reoperative antireflux surgery. The aim of this study was to evaluate the results after fundoplication revision. MATERIAL AND METHODS: All patients (n=71) undergoing fundoplication revision between 1997 and 2005 were included in this study. The follow-up data were collected both from the hospital records and during postoperative control visits, including a personal interview using a structured questionnaire; follow-up was completed by 61 patients (88.4%). RESULTS: The primary fundoplications included both open (n=21) and laparoscopic (n=40) approaches; 92% (n=56) of the reoperations were open procedures. The morbidity rate was 21% and the reoperation rate 16%. Fifty-six percent (n=34) of the patients regarded the result of their reoperative surgery as excellent, good or satisfactory at a mean follow-up of 51 months; 66% of the patients had no significant reflux symptoms after re-fundoplication. With the benefit of hindsight, 77% of the patients would again choose to undergo re-fundoplication, but only 48% of the patients would again primarily choose surgical treatment. Mortality rate was 1.4% (n=1) and in three patients the reoperative treatment required total gastrectomy. CONCLUSIONS: These suboptimal results show that surgical treatment for gastro-oesophageal reflux disease in general is far from being perfect and this is even more marked after reoperative antireflux surgery, as fundoplication revision can result in severe complications. This emphasizes the importance of proper patient selection for both initial and reoperative antireflux surgery.

Laryngopharyngeal reflux disease treated with laparoscopic fundoplication.

The objective of this clinical prospective study was to find out if laparoscopic Nissen fundoplication is an effective treatment in laryngopharyngeal reflux disease. Twenty-two consecutive patients, 16 female and 6 male, who were referred to laparoscopic fundoplication and operated by a senior gastroenterology surgeon were included in this study. Their mean age was 41 years (SD 13), and ranged from 18 to 64. The patients selected for surgical treatment had LPRD with several vocal and laryngeal symptoms. The status findings were typical for laryngopharyngeal reflux and the symptoms and signs had responded to antireflux medication. Vocal symptoms were interviewed and patients underwent laryngoscopy, esophagogastroscopy, and 24-h esophageal pH monitoring. The follow-up of symptoms and signs were 3 months after beginning of medication, before surgery, 3 months, and 1 year after surgery. The number of patients experiencing vocal symptoms decreased during the medical treatment, from the situation before medical treatment to the situation before surgery (P < 0.001), from the situation before surgery to the situation 3 months (P < 0.001) and 1 year post operation (P < 0.001), but no significant changes were found from the situation 3 months to 1 year post operation. Voice quality improved significantly only from the time point before surgery to 3 months post operation. Three months after medical treatment, laryngeal and pharyngeal findings did not decrease significantly, but several findings decreased significantly (P < 0.001) from the time point before surgery compared to 3 months and to 1 year post operation. Based on this study, the laparoscopic fundoplication is an effective and safe treatment of LPRD.

Comparison of long-term outcome of laparoscopic and conventional nissen fundoplication: a prospective randomized study with an 11-year follow-up.

OBJECTIVE: The aim of this study was to compare the long-term objective and subjective outcomes of laparoscopic and open Nissen fundoplication in a randomized clinical trial with an 11-year follow-up. SUMMARY BACKGROUND DATA: Laparoscopic Nissen fundoplication has become the method of choice in antireflux surgery, replacing its open counterpart despite the lack of long-term results from controlled clinical studies. METHODS: Between April 1992 and June 1995, 110 consecutive patients were randomized to either laparoscopic (LAP) or conventional (open) Nissen fundoplication. The objective long-term follow-up consisted of an upper gastrointestinal endoscopy and a clinical assessment; the subjective long-term outcome was investigated by personal interviews using a structured questionnaire. RESULTS: Forty-nine patients in the LAP group and 37 patients in the open group were available for evaluation. Late subjective results, including postoperative symptoms and evaluation of the surgical result, were similar in both groups. With the benefit of hindsight, 73.7% of the patients in the open group and 81.8% in the LAP group would again choose surgical treatment (P = 0.3042). In the LAP group, there were 5 (13.2%) partially or totally disrupted plications compared with the 14 (40.0%) disrupted plications in the open group (P = 0.0152). There were 10 incisional hernias in the open group compared with none in the LAP group (P < 0.001). CONCLUSIONS: At long-term follow-up, the open and LAP approaches for the Nissen fundoplication have similar long-term subjective symptomatic outcome despite the significantly higher incidence of incisional hernias and defective fundic wraps at endoscopy in the open group defining laparoscopic Nissen fundoplication as the procedure of choice in surgical management of gastroesophageal reflux disease.

Reflux laryngitis: a feasible indication for laparoscopic antireflux surgery?

Laparoscopic fundoplication is a routine surgical approach in the treatment of moderate or severe gastro-esophageal reflux disease. However, there are still contradictions regarding supraesophageal symptoms as an indication for surgery. The aim of this study was to determine the subjective symptomatic outcome and objective laryngeal findings after antireflux surgery in patients with pH monitoring proven reflux laryngitis. Between 1998 and 2002, 40 patients with reflux laryngitis underwent laparoscopic Nissen fundoplication. Patients were referred to surgery and followed-up by a specialist in otorhinolaryngology. Subjective symptoms were collected by a structured questionnaire at a median follow-up of 42 months. The objective laryngeal findings improved from the preoperative situation; at 12 months after surgery, the otorhinolaryngeal status was improved in 92.3% (n=24) of the patients. However, only 38.5% (n=10) of these patients evaluated an improvement in their voice quality. Of all, 62.5% (n=25) of the patients reported no or only mild cough or voice hoarseness symptoms postoperatively, 22.5% (n=9) had moderate symptoms, and 15.0% (n=6) suffered from difficult supraesophageal symptoms. Ninety-five percent of the patients regarded the result of their surgery excellent, good, or satisfactory. Of all, 82.5% (n=33) of the patients would still choose surgery, 7.5% (n=3) would abstain from surgery, and 10% (n=4) of the patients were hesitant about their choice. For patients suffering from supraesophageal symptoms of gastro-esophageal reflux disease with objective evidence of pharyngeal acid exposure, laparoscopic Nissen fundoplication provides a good and alternative adding to current treatment.