A Randomized, Double-Blind, Placebo-Controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients.

OBJECTIVES: Constipation is the most common GI symptom in patients with diabetes mellitus (DM). Importantly, patients with constipation have lower health-related quality of life than those without constipation. Effective therapies for constipation are limited and there is a paucity of data evaluating the treatment of constipation in diabetics. METHODS: Diabetic patients with chronic idiopathic constipation (CIC) as defined by Rome III criteria were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital. Demographic data, baseline stool patterns, and a constipation-specific quality of life survey (Patient Assessment of Constipation Quality of Life (PAC-QOL)) were obtained. Baseline colonic transit time (CTT) was evaluated utilizing the wireless motility capsule. Patients were randomized in a double-blind fashion to 48 mcg per day lubiprostone or placebo for 8 weeks. The primary end point measured was the difference in number of spontaneous bowel movements (SBMs) per week vs. baseline for each group at each week after initiation of therapy. Secondary end points included changes in CTT after 4 weeks of therapy, PAC-QOL after 8 weeks of therapy, and changes from baseline in associated gastrointestinal (GI) symptoms as well as need for rescue medication at 2, 4, and 8 weeks. RESULTS: Seventy-six patients (mean age, 56.9±9.1 years, 62% females) were randomized. There were no significant differences between the two groups' baseline data or demographics. During the 8-week treatment period, patients in the lubiprostone group experienced an average of 1.83±0.80 (P=0.02) more SBMs per week than those in the placebo group as compared with baseline. The duration of CTT at Week 4 was shorter by an average of 13 h compared with baseline in the lubiprostone group, and was prolonged by an average of 7 h compared with baseline in the placebo group, leading to a treatment effect of 20.3±7.3 h (P=0.006). PAC-QOL improved in both the groups; however, there was no significant difference between the groups. There was no difference in associated GI symptoms and need for rescue medication between the two groups after 8 weeks. There were no serious adverse events reported during the study. CONCLUSIONS: This study suggests that lubiprostone is a safe and effective treatment for increasing weekly SBMs and decreasing CTT in patients with DM and CIC.

Utility of diffusion-weighted MRI in distinguishing benign and malignant hepatic lesions.

PURPOSE: To evaluate apparent diffusion coefficient (ADC) values for characterization of a variety of focal liver lesions and specifically for differentiation of solid benign lesions (focal nodular hyperplasia [FNH] and adenomas) from solid malignant neoplasms (metastases and hepatocellular carcinoma [HCC]) in a large case series. MATERIALS AND METHODS: A total of 542 lesions in 382 patients were evaluated. ADC values were measured in 166 hemangiomas, 112 hepatomas, 107 metastases, 95 cysts, 10 abscesses, 43 FNH, and nine adenomas. ADCs of 1.5 and 1.6 (x10(-3) mm(2)/second) were selected as threshold values to separate benign and malignant lesions. Sensitivity, specificity, positive, and negative predictive values (PPV, NPV) were calculated. Comparisons were carried out with studentized range test. RESULTS: There was high interobserver agreement in ADC measurements for all lesion types. The mean ADCs for cysts was 3.40 (x10 (-3) mm(2)/second), hemangiomas 2.26, FNH 1.79, adenomas 1.49, abscesses 1.97, HCC 1.53, and metastases 1.50. The mean ADC for benign lesions was 2.50 and for malignant lesions was 1.52. Cysts were easily distinguished from other lesions. There was, however, overlap between solid benign and malignant lesions. CONCLUSION: Benign lesions have higher mean ADC values than malignant lesions. However, ADC values of solid benign lesions (FNH and adenomas) are similar to malignant lesions (metastases, HCC) limiting the value of diffusion weighted imaging (DWI) for differentiating solid liver masses.

Midesophageal Pulsion Diverticulum Resulting From Hypercontractile (Jackhammer) Esophagus.

We report a patient with significant dysphagia from hypercontractile "jackhammer" esophagus and a midesophageal pulsion diverticulum. This was treated with a thoracoscopic diverticulectomy and a long esophageal myotomy sparing the lower esophageal sphincter (LES). We describe the clinical diagnosis and surgical treatment of this uncommon esophageal motility disorder. To our knowledge, this is the first report in the literature of a midesophageal diverticulum caused by jackhammer esophagus. We propose that in the setting of normal LES function, successful treatment should include diverticulectomy with an LES-sparing myotomy.

Efficacy of Endoscopic Mucosal Resection for Management of Small Duodenal Neuroendocrine Tumors.

BACKGROUND: Endoscopic mucosal resection (EMR) for small (<20 mm) duodenal neuroendocrine tumors (NETs) remains controversial because of their rarity. MATERIALS AND METHODS: This is a retrospective cohort study of patients with surgically or endoscopically resected duodenal NETs from 2001 to 2011. The primary outcome is the rate of disease-free status following resection. A secondary outcome is the sensitivity of endoscopic ultrasound (EUS) in determining NET appropriateness for EMR. RESULTS: Thirty patients underwent resection of duodenal NETs (EMR 20, surgery 10). Tumor was present at the margins in 40% of EMR-resected NETs and 10% of surgically resected NETs. Five patients who underwent EMR had residual disease treated with repeat EMR (3) and surgery (2). EUS demonstrated 96% sensitivity in determining lesions limited to the submucosa. CONCLUSIONS: EMR for small duodenal NETs can be a safe and effective alternative to surgery in carefully selected patients. EUS is a useful adjunct in determining depth of invasion for duodenal NETs.