The Effect of Race in Patients with Achalasia Diagnosed With High-Resolution Esophageal Manometry.

BACKGROUND: The advent of the Chicago Classification for esophageal motility disorders allowed for clinically reproducible subgrouping of patients with achalasia based on manometric phenotype. However, there are limited data with regards to racial variation using high-resolution esophageal manometry (HREM). The aim of our study was to evaluate the racial differences in patients with achalasia diagnosed with HREM using the Chicago Classification. We evaluated the clinical presentation, treatment decisions and outcomes between blacks and non-blacks with achalasia to identify potential racial disparities. MATERIALS AND METHODS: We performed a retrospective review of consecutive patients referred for HREM at a single tertiary referral center from June 2008 through October 2012. All patients diagnosed with achalasia on HREM according to the Chicago Classification were included. Demographic, clinical and manometric data were abstracted. All studies interpreted before the Chicago Classification was in widespread use were reanalyzed. Race was defined as black or non-black. Patients who had missing data were excluded. Proportions were compared using chi-squared analysis and means were compared using the Student's t-test. RESULTS: A total of 1,268 patients underwent HREM during the study period, and 105 (8.3%) were manometrically diagnosed with achalasia (53% female, mean age: 53.8 ± 17.0 years) and also met the aforementioned inclusion and exclusion criteria. A higher percentage of women presented with achalasia in blacks as compared to whites or other races (P < 0.001). Non-blacks were more likely to present with reflux than blacks (P = 0.01), while blacks were more likely to be treated on the inpatient service than non-blacks (P < 0.001). There were no other significant differences noted in clinical presentation, treatment decisions and treatment outcomes among blacks and non-blacks. CONCLUSIONS: Our study highlights possible racial differences between blacks and non-blacks, including a higher proportion of black women diagnosed with achalasia and most blacks presenting with dysphagia. There is possibly a meaningful interaction of race and sex in the development of achalasia that might represent genetic differences in its pathophysiology. Further prospective studies are required to identify such differences.

Aprepitant Has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders.

BACKGROUND & AIMS: There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome. METHODS: We conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months. Patients were randomly assigned to groups given oral aprepitant (125 mg/day, n = 63) or placebo (n = 63). The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-to-100 visual analog scale (VAS) of nausea severity. We calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis. RESULTS: Aprepitant did not reduce symptoms of nausea, based on the primary outcome measure (46% reduction in the VAS score in the aprepitant group vs 40% reduction in the placebo group; relative risk, 1.2; 95% CI, 0.8-1.7) (P = .43). However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity (measured by the 0-5 Gastroparesis Clinical Symptom Index) for nausea (1.8 vs 1.0; P = .005), vomiting (1.6 vs 0.5; P = .001), and overall symptoms (1.3 vs 0.7; P = .001). Adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant (22 of 63 patients, 35% vs 11 of 63, 17% in the placebo group) (P = .04). CONCLUSIONS: In a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in VAS score was used as the primary outcome. However, aprepitant had varying effects on secondary outcomes of symptom improvement. These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant. ClinicalTrials.gov no: NCT01149369.

Roles of High-resolution Manometry in Predicting Incomplete Bolus Transit in Patients With Dysphagia.

BACKGROUND: High-resolution manometry (HRM) is used to assess esophageal motility diseases. Abnormalities in a number of HRM parameters have been reported in patients with dysphagia. However, it is unclear whether some of abnormal HRM parameters are predictive of dysphagia. The aim of this retrospective study was to investigate the roles of HRM parameters in predicting incomplete bolus clearance (IBC) in patients with dysphagia using high-resolution impedance manometry. METHODS: A total of 644 wet swallows were reviewed and analyzed in 63 patients with symptoms of dysphagia or reflux who underwent a clinical high-resolution impedance manometry test. IBC was defined based on impedance measurement. The relationship of each of abnormal HRM parameters with IBC was analyzed and their roles in predicting IBC were determined. RESULTS: Patients with symptoms of both dysphagia and reflux showed the highest IBC rate, and patients with symptoms of reflux had the lowest IBC rate. The IBC was more prevalent in the distal esophagus. Premature contractions and peristalsis with large breaks were associated with a higher IBC rate in the proximal esophagus (P<0.05); large breaks, ineffective peristalsis, and abnormalities of the esophageal gastric junction functions were associate with higher IBC rates in the distal esophagus (P<0.05). Abnormalities in a number of motility parameters were able to predict IBC with high specificities and/or high sensitivity, such as pan esophageal pressurization, ineffective peristalsis, and large breaks. Abnormal integrative relaxation pressure of the lower esophageal sphincter with concurrent pan esophageal pressurization, ineffective peristalsis, or large breaks is predictive of IBC with nearly 100% of specificity. CONCLUSIONS: Abnormalities in a number of HRM parameters are not only useful in diagnosing esophageal motility diseases, but also valuable in predicting IBC during swallowing.

Three-Dimensional Anorectal Manometry Enhances Diagnostic Gain by Detecting Sphincter Defects and Puborectalis Pressure.

BACKGROUND: Constipation and fecal incontinence (FI) are common and are often evaluated with anorectal manometry. Three-dimensional high-resolution anorectal manometry (HRAM) is a promising technology; however, implementation has been limited by lack of metrics and unclear clinical utility. AIM: To investigate the diagnostic utility of 3D HRAM compared to 2D HRAM. METHODS: Three-dimensional HRAM studies performed from April 2012 to October 2013 were identified and re-interpreted by two blinded investigators examining 3D function. Disagreements were resolved by a third investigator. Puborectalis (PR) visualization, focal defects, and dyssynergy were reported. Differences between groups were analyzed with Fisher's exact test. Discordance was analyzed with McNemar Chi-square test. RESULTS: Two hundred and twenty-one 3D HRAM studies were identified. Mean age and BMI were 52.2 ± 17.4 and 27.1 ± 7.5 years (81% female, 74% white). Most common indications for 3D HRAM were constipation (65%) and FI (28%). PR function was visualized in 81% (rest), 97% (squeeze), and 73% (strain). PR was visualized less often at rest in FI than constipation (68 vs. 85%, p = 0.007). Defects were identified twice as often in FI than constipation (19 vs. 10%, p = 0.113). Twenty-nine defects (86% anterior) were visualized on 3D HRAM. Inter-reader agreement was moderate for PR function (κ = 0.471), but fair for focal defects (κ = 0.304). CONCLUSIONS: PR function and focal defects can be visualized on 3D-HRAM with added diagnostic benefit compared to 2D. Fair inter-reader agreement for focal defects highlights the need for quantitative metrics.

Learning curve for peroral endoscopic myotomy.

BACKGROUND AND STUDY AIMS: Although peroral endoscopic myotomy (POEM) is being performed more frequently, the learning curve for gastroenterologists performing the procedure has not been well studied. The aims of this study were to define the learning curve for POEM and determine which preoperative and intraoperative factors predict the time that will be taken to complete the procedure and its different steps. PATIENTS AND METHODS: Consecutive patients who underwent POEM performed by a single expert gastroenterologist for the treatment of achalasia or spastic esophageal disorders were included. The POEM procedure was divided into four steps: mucosal entry, submucosal tunneling, myotomy, and closure. Nonlinear regression was used to determine the POEM learning plateau and calculate the learning rate. RESULTS: A total of 60 consecutive patients underwent POEM in an endoscopy suite. The median length of procedure (LOP) was 88 minutes (range 36 - 210), and the mean (± standard deviation [SD]) LOP per centimeter of myotomy was 9 ± 5 minutes. The total operative time decreased significantly as experience increased (P < 0.001), with a "learning plateau" at 102 minutes and a "learning rate" of 13 cases. The mucosal entry, tunneling, and closure times decreased significantly with experience (P < 0.001). The myotomy time showed no significant decrease with experience (P = 0.35). When the mean (± SD) total procedure times for the learning phase and the corresponding comparator groups were compared, a statistically significant difference was observed between procedures 11 - 15 and procedures 16 - 20 (15.5 ± 2.4 min/cm and 10.1 ± 2.7 min/cm, P = 0.01) but not thereafter. A higher case number was significantly associated with a decreased LOP (P < 0.001). CONCLUSION: In this single-center retrospective study, the minimum threshold number of cases required for an expert interventional endoscopist performing POEM to reach a plateau approached 13.

Comprehensive analysis of efficacy and safety of peroral endoscopic myotomy performed by a gastroenterologist in the endoscopy unit: a single-center experience.

BACKGROUND AND AIMS: The safety and efficacy of peroral endoscopic myotomy (POEM) when performed by gastroenterologists in the endoscopy unit are currently unknown. The aims of this study were to assess (1) the safety and efficacy of POEM in which all procedures were performed by 1 gastroenterologist in the endoscopy unit, and (2) the predictors of adverse events and nonresponse. METHODS: All consecutive patients who underwent POEM at 1 tertiary center were included. Clinical response was defined by a decrease in the Eckardt score to 3 or lower. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon's severity grading system. RESULTS: A total of 60 consecutive patients underwent POEM in the endoscopy suite with a mean procedure length of 99 minutes. The mean length of submucosal tunnel was 14 cm and the mean myotomy length was 11 cm. The median length of hospital stay was 1 day. Among 52 patients with a mean follow-up period of 118 days (range 30-750), clinical response was observed in 48 patients (92.3%). There was a significant decrease in Eckardt score after POEM (8 vs 1.19, P < .0001). The mean lower esophageal sphincter pressure decreased significantly after POEM (29 mm Hg vs 11 mm Hg, P < .0001). A total of 10 adverse events occurred in 10 patients (16.7%): 7 rated as mild, 3 as moderate, and none as severe. Procedure length was the only predictor of adverse events (P = .01). pH impedance testing was completed in 25 patients, and 22 (88%) had abnormal acid exposure, but positive symptom correlation was present in only 6 patients. All patients with symptomatic reflux were successfully treated with proton pump inhibitors. CONCLUSIONS: POEM can be effectively and safely performed by experienced gastroenterologists at a tertiary care endoscopy unit. Adverse events are infrequent, and most can be managed intraprocedurally. Post-POEM reflux is frequent but can be successfully managed medically.

Refractory gastroparesis can be successfully managed with endoscopic transpyloric stent placement and fixation (with video).

BACKGROUND AND AIMS: Medical treatment options for gastroparesis are limited. Data from studies of botulinum toxin and surgical pyloroplasty suggest that disruption of the pylorus can result in symptomatic improvement in some patients with refractory gastroparetic symptoms. The aim of this study was to determine the clinical response to transpyloric stent (TPS) placement in patients with gastroparetic symptoms refractory to standard therapy. METHODS: Patients with gastroparesis refractory to medical treatment were referred for TPS placement for salvage therapy. Self-reported symptom improvement, stent migration rate, and pre- and post-stent gastric-emptying study results were collected. RESULTS: A total of 30 patients with refractory gastroparesis underwent 48 TPS procedures. Of these, 25 of 48 (52.1%) were performed in patients admitted to the hospital with intractable gastroparetic symptoms. Successful stent placement in the desired location across the pylorus (technical success) was achieved during 47 procedures (98%). Most (n = 24) stents were anchored to the gastric wall by using endoscopic suturing with a mean number of sutures of 2 (range 1-3) per procedure. Clinical response was observed in 75% of patients, and all inpatients were successfully discharged. Clinical success in patients with the predominant symptoms of nausea and vomiting was higher than in those patients with a predominant symptom of pain (79% vs 21%, P = .12). A repeat gastric-emptying study was performed in 16 patients, and the mean 4-hour gastric emptying normalized in 6 patients and significantly improved in 5 patients. Stent migration was least common (48%) when stents were sutured. CONCLUSION: TPS placement is a feasible novel endoscopic treatment modality for gastroparesis and improves both symptoms and gastric emptying in patients who are refractory to medical treatment, especially those with nausea and vomiting. TPS placement may be considered as salvage therapy for inpatients with intractable symptoms or potentially as a method to select patients who may respond to more permanent therapies directed at the pylorus.

Herbal therapy is equivalent to rifaximin for the treatment of small intestinal bacterial overgrowth.

OBJECTIVE: Patients with small intestine bacterial overgrowth (SIBO) have chronic intestinal and extraintestinal symptomatology which adversely affects their quality of life. Present treatment of SIBO is limited to oral antibiotics with variable success. A growing number of patients are interested in using complementary and alternative therapies for their gastrointestinal health. The objective was to determine the remission rate of SIBO using either the antibiotic rifaximin or herbals in a tertiary care referral gastroenterology practice. DESIGN: One hundred and four patients who tested positive for newly diagnosed SIBO by lactulose breath testing (LBT) were offered either rifaximin 1200 mg daily vs herbal therapy for 4 weeks with repeat LBT post-treatment. RESULTS: Three hundred ninety-six patients underwent LBT for suspected SIBO, of which 251 (63.4%) were positive 165 underwent treatment and 104 had a follow-up LBT. Of the 37 patients who received herbal therapy, 17 (46%) had a negative follow-up LBT compared to 23/67 (34%) of rifaximin users (P=.24). The odds ratio of having a negative LBT after taking herbal therapy as compared to rifaximin was 1.85 (CI=0.77-4.41, P=.17) once adjusted for age, gender, SIBO risk factors and IBS status. Fourteen of the 44 (31.8%) rifaximin non-responders were offered herbal rescue therapy, with 8 of the 14 (57.1%) having a negative LBT after completing the rescue herbal therapy, while 10 non-responders were offered triple antibiotics with 6 responding (60%, P=.89). Adverse effects were reported among the rifaximin treated arm including 1 case of anaphylaxis, 2 cases of hives, 2 cases of diarrhea and 1 case of Clostridium difficile. Only one case of diarrhea was reported in the herbal therapy arm, which did not reach statistical significance (P=.22). CONCLUSION: SIBO is widely prevalent in a tertiary referral gastroenterology practice. Herbal therapies are at least as effective as rifaximin for resolution of SIBO by LBT. Herbals also appear to be as effective as triple antibiotic therapy for SIBO rescue therapy for rifaximin non-responders. Further, prospective studies are needed to validate these findings and explore additional alternative therapies in patients with refractory SIBO.

Multichannel intraluminal impedance-pH testing is clinically useful in the management of patients with gastroesophageal reflux symptoms.

BACKGROUND: Multichannel intraluminal impedance-pH testing (MII-pH) allows for the detection of acid and non-acid reflux, thus, increasing yield over pH testing. Limited data exist on how physicians use test results in practice. AIM: The aim of our study was to evaluate the influence of MII-pH testing on patient care. METHODS: We reviewed records of patients with symptoms of gastroesophageal reflux disease who underwent MII-pH testing. Management decisions evaluated included changes in prescribed medications and surgical consultation for anti-reflux surgery. Statistical analysis was performed using Pearson Chi square test, and multivariable logistic regression. RESULTS: MII-pH testing resulted in a medication change in 41% of patients, surgical consultation in 19.7%, and anti-reflux surgery in 11.1%. In patients who were not on proton pump inhibitor (PPI) therapy, MII-pH results were most useful in the decision to start a PPI. On PPI therapy, results were more often used to decide whether to increase (32.3%) or switch the PPI (23.5%) in patients with continued acid reflux. Results were most useful to stop the PPI in normal studies (11.1%). More patients with non-acid reflux (14.3%) and normal results (19.7%) were started on a neuromodulator compared to other diagnoses. The MII-pH result was most useful in the decision to start baclofen or bethanecol when the patient was found to have non-acid reflux (25%). Patients with an abnormal MII-pH or abnormal MII alone were more likely to be referred to surgery (OR 19.5, p < 0.001; OR 19.77, p < 0.001). CONCLUSIONS: MII-pH testing impacted medical or surgical management in over half the patients tested.

Pancreatic metastasis from a solitary fibrous tumor of the kidney: a rare cause of acute recurrent pancreatitis.

Solitary fibrous tumors are unusual spindle cell neoplasms that uncommonly originate from the kidney. We report a case of a 43-year old male who presented with acute recurrent pancreatitis secondary to a mass in the head of the pancreas. Endoscopic ultrasound with fine needle aspiration (EUS-FNA) was performed. Cytology revealed solitary fibrous tumor of the kidney. This is the first reported case of solitary fibrous tumor metastasizing to the pancreas and presenting as acute recurrent pancreatitis.

Association of tattooing and hepatitis C virus infection: a multicenter case-control study.

UNLABELLED: Although injection drug use (IDU) and blood transfusions prior to 1992 are well-accepted risk factors for hepatitis C virus (HCV) infection, many studies that evaluated tattooing as a risk factor for HCV infection did not control for a history of IDU or transfusion prior to 1992. In this large, multicenter, case-control study, we analyzed demographic and HCV risk factor exposure history data from 3,871 patients, including 1,930 with chronic HCV infection (HCV RNA-positive) and 1,941 HCV-negative (HCV antibody-negative) controls. Crude and fully adjusted odds ratios (ORs) of tattoo exposure by multivariate logistic regression in HCV-infected versus controls were determined. As expected, IDU (65.9% versus 17.8%; P < 0.001), blood transfusion prior to 1992 (22.3% versus 11.1%; P < 0.001), and history of having one or more tattoos (OR, 3.81; 95% CI, 3.23-4.49; P < 0.001) were more common in HCV-infected patients than in control subjects. After excluding all patients with a history of ever injecting drugs and those who had a blood transfusion prior to 1992, a total of 1,886 subjects remained for analysis (465 HCV-positive patients and 1,421 controls). Among these individuals without traditional risk factors, HCV-positive patients remained significantly more likely to have a history of one or more tattoos after adjustment for age, sex, and race/ethnicity (OR, 5.17; 95% CI, 3.75-7.11; P < 0.001). CONCLUSION: Tattooing is associated with HCV infection, even among those without traditional HCV risk factors such as IDU and blood transfusion prior to 1992.