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It is unknown why some cases of Barrett’s esophagus progress to invasive malignant disease rapidly while others do so more slowly or not at all. The aim of this study was to identify demographic and endoscopic factors that predict dysplastic and neoplastic progression in patients with Barrett’s esophagus.Patients with Barrett’s esophagus who were assessed in 2000–2010 were assessed for inclusion in this retrospective study. Demographic and endoscopic variables were collected from an endoscopy database and the medical chart. Dysplastic and neoplastic progression was examined by time-to-event analysis. We used Cox proportional hazard regression modelling and generalized estimating equation methods to identify variables that were most predictive of neoplastic progression.A total of 518 patients had Barrett’s esophagus confirmed by endoscopy and pathology and at least 2 surveillance visits. Longer Barrett’s esophagus segment (≥ 3 cm) (odds ratio [OR] 1.2, 95% confidence interval [CI] 1.1–1.3) and increased age (≥ 60 yr) (OR 3.5, 95% CI 1.7–7.4) were independent predictors of progression from nondysplasia to dysplastic or neoplastic grades. Presence of mucosal irregularities (OR 8.6, 95% CI 2.4–30.4) and increased age (OR 5.1, 95% CI 1.6–16.6) were independent predictors of progression from nondysplasia to high-grade dysplasia or adenocarcinoma.Increased age, longer Barrett’s segment and presence of mucosal irregularities were associated with increased risk of dysplastic and neoplastic progression. In addition to dysplasia, these factors may help stratify patients according to risk of neoplastic progression and be used to individualize surveillance. More prospective studies with larger samples are required to validate these results.On ignore pour quelle raison certains cas d’oesophage de Barrett évoluent rapidement vers une maladie maligne envahissante, tandis que d’autres progressent lentement ou se stabilisent. Le but de cette étude était d’identifier les facteurs démographiques et endoscopiques prédicteurs d’une progression dysplasique et néoplasique chez les patients porteurs d’un oesophage de Barrett.Des patients présentant un oesophage de Barrett ayant été examinés entre 2000 et 2010, ont été évalués en vue de leur participation à cette étude rétrospective. Les variables démographiques et endoscopiques ont été recueillies à partir d’une base de données endoscopiques et des dossiers médicaux. La progression dysplasique et néoplasique a été évaluée par analyse du délai de survenue de l’événement. Nous avons utilisé le modèle de la régression de Cox (risques proportionnels) et les équations d’estimation généralisée afin d’identifier les variables les plus prédictives d’une progression néoplasique.En tout, 518 patients présentaient un oesophage de Barrett confirmé par examen endoscopique et anatomopathologique et comptaient au moins 2 visites de surveillance. La présence de segments d’oesophage de Barrett plus longs (≥ 3 cm) (rapport des cotes [RC] 1,2, intervalle de confiance à 95 % [IC] 1,1–1,3) et un âge avancé (≥ 60 ans) (RC 3,5, IC à 95 % 1,7–7,4) ont été des prédicteurs indépendants de progression d’un grade non dysplasique vers un grade dysplasique. La présence d’irrégularités muqueuses (RC 8,6, IC à 95 % 2,4–30,4) et l’âge avancé (RC 5,1, IC à 95 % 1,6–16,6) ont été des prédicteurs indépendants de progression de la non-dysplasie vers une dysplasie de haut grade ou l’adénocarcinome.L’âge avancé, des segments d’oesophage de Barrett plus longs et la présence d’irrégularités muqueuses ont été associés à un risque accru de progression dysplasique et néoplasique. En plus de la dysplasie, ces facteurs peuvent faciliter la stratification des patients selon le risque de progression néoplasique et servir à individualiser la surveillance. Il faudra procéder à d’autres études prospectives auprès d’échantillons de population plus volumineux pour valider ces résultats.

We previously demonstrated feasibility, safety, and a reproducible histologic bulking effect after injection of dextranomer hyaluronic acid copolymer (DxHA) into the gastroesophageal junction of rabbits. In the current study, we investigated the potential for DxHA to augment the lower esophageal sphincter (LES) in a porcine model of gastroesophageal reflux disease (GERD).Twelve Yucatan miniature pigs underwent LES manometry and 24-hour ambulatory pH monitoring at baseline, after cardiomyectomy, and 6weeks after randomization to endoscopic injection of either DxHA or saline at the LES. After necropsy, the foregut, including injection sites, was histologically examined.Pigs in both groups had similar weight progression. Cardiomyectomy induced GERD in all animals, as measured by a rise in the median % of time pH5 from 0.6 to 11.6 (p=0.02). Endoscopic injection of DxHA resulted in a higher median difference in LES length (1.8cm vs. 0.4cm, p=0.03). In comparison with saline injection, DxHA resulted in 120% increase in LES pressure, and 76% decrease in the mean duration of reflux episodes, but these results were not statistically significant. Injection of DxHA induced a foreign body reaction with fibroblasts and giant cells.Porcine cardiomyectomy is a reproducible animal GERD model. Injection of DxHA may augment the LES, offering a potential therapeutic effect in GERD.

Background Pneumatic dilation (PD) and laparoscopic Heller's myotomy (LHM) are the mainstays of therapy in idiopathic achalasia. Equipoise exists in choosing the first-line therapy. Objective To assess comparative efficacies and adverse event rates of these methods. Design Intention-to-treat, fixed-model, Mantel-Haenszel meta-analysis of randomized, controlled trials comparing PD with LHM. Setting Randomized controlled trial comparing PD versus LHM. Patients Patients with newly diagnosed idiopathic achalasia. Intervention Comprehensive electronic and manual literature search from 1966 to March 2012 independently by two reviewers. Main Outcome Measurements Response rate, rate of different adverse events, and quality of life after each therapy. Results Three of 161 retrieved studies between 2007 and 2011, including 346 patients, were included. At 1 year, the cumulative response rate was significantly higher with LHM (86% vs 76%, odds ratio 1.98 (confidence interval 1.14-3.45); P = .02), with no significant heterogeneity ( P = .39; I 2 0%). Rates of major mucosal tears requiring subsequent intervention with LHM were significantly lower than those of esophageal perforation with PD requiring postprocedural medical or surgical therapy (0.6% and 4.8%, respectively; P = .04). Postprocedural rates of gastroesophageal reflux, lower esophageal sphincter pressures, and quality of life scores did not differ in trials with sufficient data. Data on longer follow-up were not available. Limitations Lack of data on follow-ups over 1 year and a small number of included studies. Conclusion This meta-analysis suggests that LHM may provide greater response rates as compared with graded PD in the treatment of newly diagnosed idiopathic achalasia, with lesser rates of major adverse events, in up to 1 year after treatment, although additional data are needed to confirm the validity of this conclusion in long-term follow-up.

Eosinophilic esophagitis (EoE) is now recognized as a common cause of dysphagia. Eosinophilic infiltration of the esophagus has also been associated with other conditions, such as gastroesophageal reflux disease (GERD); however, the incidence, pattern, and clinical significance of eosinophilic infiltration in achalasia are poorly documented. We sought to characterize this histological finding in patients undergoing Heller myotomy (HM) for achalasia. Ninety-six patients undergoing laparoscopic HM for primary achalasia between 1999 and 2008 were identified from a prospective database. Serial mid and distal per-endoscopic esophageal biopsies taken from patients before and after surgery were assessed for the presence of elevated intraepithelial eosinophils (EIEs). Slides from patients with reports suggestive of EIE were reviewed independently by two pathologists, and the highest eosinophil count/high-power field (eos/hpf) was recorded. Dysphagia scores (0 = none to 5 = severe dysphagia), GERD health-related quality of life scores (0 = best to 45 = worst), and 24-hour pH results were compared before and 3 months after surgery. We related the highest eos to the symptoms and response to HM. Data are presented as median (range). Paired t-test and Wilcoxon signed-rank test determined significance, *P < 0.05. Of 96 patients with achalasia, 50 had undergone pre-HM biopsies revealing EIE in 17/50 (34%), with a median of 3 eos/hpf (1-21). Two patients were found to have superimposed esophageal candidiasis. One patient met the pathologic criteria for EoE. Twenty-five of 50 (50%) postoperative biopsies demonstrated a median of 5 eos/hpf (1-62) for a total of 28/50 patients (56%) with EIE in either the preoperative or postoperative period. Four patients (8%) met the pathologic criteria for EoE, and two demonstrated persistent esophageal candidiasis. A decrease in eosinophils was found in 6/28 patients (21%) from 3/hpf (1-21) to 0.5/hpf (0-4). Increase in eosinophils was found in 22/28 patients (79%) from 0.5/hpf (0-8) to 5/hpf (1-62). Preoperative and postoperative dysphagia scores were available in 23 patients. Dysphagia scores improved in 22/23 patients. (3 [0-5] to 0 [0-2])*. Preoperative and postoperative GERD scores were available in 21 patients. GERD scores improved in 20/21 patients (10 [3-38] to 2 [2-14])*. Four of 13 patients (30.7%) demonstrated significant reflux in the postoperative period. No difference in clinical response to HM was detected between patients with preoperative EIE compared with patients with no EIE. No correlation between postoperative esophageal pH and eos was observed. A significant number of patients with achalasia demonstrate esophageal eosinophilic infiltration even at numbers demonstrable in patients with EoE (8% 4/50). While the interaction between achalasia and esophageal eosinophilic infiltration needs further investigation, this does not represent a distinct clinical entity. Thus, the presence of esophageal eosinophils in patients presenting with dysphagia should not preclude further work-up for other etiologies, including achalasia.

o p h a p 4 Upper GI hemorrhage is a common complication of gastroduodenal tumors. Bleeding from these neoplasms s generally difficult to control and is associated with high ebleeding rates. Current modalities for management inlude endoscopy, radiotherapy, interventional angiograhy, and surgery. Hemospray (Cook Medical, Winston-Salem, NC) is an merging endoscopic hemostatic technology that was reently introduced in the management of upper GI bleedng.2 It is composed of a proprietary inorganic powder that, when put in contact with moisture in the GI tract, becomes coherent and adhesive, thus serving as a mechanical barrier for hemostasis. Given its malleable nature, its ability to cover large areas, and especially the lack of direct contact with target tissue as it is sprayed onto the lesion, its use in bleeding gastroduodenal tumors has been suggested.2 Animal studies have demonstrated its safety nd its lack of absorption by the GI tract; it is also elimiated within 48 hours of application with no reported owel obstruction.3 Recently, a prospective, pilot study involving 20 patients with nonmalignant upper GI bleeding showed that the application of Hemospray was associated with a 95% initial hemostasis with no active bleeding seen on repeat EGD at 72 hours, followed by total elimination of the inorganic substance without complications such as intestinal obstruction or embolization.2 To our knowledge, the following describes the first 5 reported cases of upper GI hemorrhage secondary to gas

The palliation of dysphagia in metastatic esophageal cancer remains a challenge, and the optimal approach for this difficult clinical scenario is not clear. We therefore sought to define and determine the efficacy of various treatment options used at our institution for this condition. We reviewed a prospective database for all patients managed in an esophageal cancer referral centre over a 5-year period. All patients receiving palliation of malignant dysphagia were reviewed for demographics, palliative treatment modalities, complications, and dysphagia scores (0 = none to 4 = complete). The Wilcoxon signed rank test was used to determine significance (p < 0.05). During 2004&ndash, 2009, 63 patients with inoperable esophageal cancer were treated for palliation of dysphagia. The primary treatment was radiotherapy in 79% (brachytherapy in 18 of 50, external-beam in 10 of 50, both types in 22 of 50), and stenting in 21%. Mean wait time from diagnosis to treatment was 22 days in the stent group and 54 days in the radiotherapy group (p = 0.003). Mean duration of treatment was 1 day in the stent group and 40 days in the radiotherapy group (p = 0.001). In patients treated initially by stenting, dysphagia improved within 2 weeks of treatment in 85% of patients (dysphagia score of 0 or 1). However, 20% of patients presented with recurrence of dysphagia at 10 weeks of treatment. In the radiotherapy group, the onset of palliation was slower, with only 50% of patients palliated at 2 weeks (dysphagia score of 0 or 1). However, long-term palliation was more satisfactory, with 90% of patients remaining palliated after 10 weeks of treatment. In inoperable esophageal cancer at our centre, radiation treatment provided durable long-term relief, but came at a high price of a long wait time for initiation of treatment and a long lag time between initiation of treatment and relief of symptoms. On the other hand, endoluminal stenting provided more rapid and effective early relief from symptoms, but was affected by recurrence of dysphagia in the long-term. It is now time for a prospective randomized trial to assess the safety and efficacy of combined-modality treatment with both endoluminal stenting and radiation therapy compared with either treatment alone.

Purpose Acute radiation proctitis (ARP) is a common side effect of pelvic radiotherapy, and its management is challenging in daily practice. The present phase I/II study evaluates the safety and efficacy of the botulinum toxin A (BTX-A) in ARP treatment for rectal cancer patients undergoing neoadjuvant high-dose-rate endorectal brachytherapy (HDREBT). Methods and Materials Fifteen patients, treated with neoadjuvant HDREBT, 26-Gy in 4 fractions, received the study treatment that consisted of a single injection of BTX-A into the rectal wall. The injection was performed post-HDREBT and prior to the development of ARP. The control group, 20 such patients, did not receive the BTX-A injection. Both groups had access to standard treatment with hydrocortisone rectal aerosol foam (Cortifoam) and anti-inflammatory and narcotic medication. The ARP was clinically evaluated by self-administered daily questionnaires using visual analog scores to document frequency and urgency of bowel movements, rectal burning/tenesmus, and pain symptoms before and after HDREBT. Results At the time of this analysis, there was no observed systemic toxicity. Patient compliance with the self-administered questionnaire was 100% from week 1 to 4, 70% during week 5, and 40% during week 6. The maximum tolerated dose was established at the 100-U dose level, and noticeable mean differences were observed in bowel frequency ( p = 0.016), urgency ( p = 0.007), and pain ( p = 0.078). Conclusions This study confirms the feasibility and efficacy of BTX-A intervention at 100-U dose level for study patients compared to control patients. A phase III study with this dose level is planned to validate these results.

Background & Aims: Randomized trials suggest high-dose proton-pump inhibitors (PPIs) administered before gastroscopy in suspected upper gastrointestinal bleeding downstage bleeding ulcer stigmata. We assessed the cost-effectiveness of this approach. Methods: A decision model compared high-dose IVPPI initiated while awaiting endoscopy with IVPPI administration on the basis of endoscopic findings. IVPPIs were given to all patients undergoing endoscopic hemostasis for 72 hours thereafter. Once the IV regimen was completed or for patients with low-risk endoscopic lesions, an oral daily PPI was given for the remainder of the time horizon (30 days after endoscopy). The unit of effectiveness was the proportion of patients without rebleeding, representing the denominator of the cost-effectiveness ratio (cost per no rebleeding). Probabilities and costs were derived from the literature and national databases. Results: IVPPIs before endoscopy were both slightly more costly and effective than after gastroscopy in the U.S. and Canadian settings, with cost-effectiveness ratios of US$5048 versus $4933 and CAN$6064 versus $6025 and incremental costs of US$45,673 and CAN$19,832 to prevent one additional rebleeding episode, respectively. Sensitivity analyses showed robust results in the US In Canada, intravenous proton-pump inhibitors (IVPPIs) before endoscopy became more effective and less costly (dominant strategy) when the uncomplicated stay for high-risk patients increased above 6 days or that of low-risk patients decreased below 3 days. Conclusions: With conservative estimates and high-quality data, IVPPIs given before endoscopy are slightly more effective and costly than no administration. In Canada, this approach becomes dominant as the duration of hospitalization for high-risk ulcer patients increases or that of low-risk ulcer patients decreases.

BACKGROUND: Optimal management of obscure gastrointestinal bleeding (OGIB) remains unclear.OBJECTIVE: To evaluate diagnostic yields and downstream clinical outcomes comparing video capsule endoscopy (VCE) with push enteroscopy (PE).METHODS: Patients with OGIB and negative esophagogastroduodenoscopies and colonoscopies were randomly assigned to VCE or PE and followed for 12 months. End points included diagnostic yield, acute or chronic bleeding, health resource utilization and crossovers.RESULTS: Data from 79 patients were analyzed (VCE n=40; PE n=39; 82.3% overt OGIB). VCE had greater diagnostic yield (72.5% versus 48.7%; PCONCLUSIONS: A VCE-first approach had a significant diagnostic advantage over PE-first in patients with OGIB, especially with regard to detecting small bowel lesions, affecting clinical certainty and subsequent further small bowel investigations, with no subsequent differences in bleeding or resource utilization outcomes in follow-up. These findings question the clinical relevance of many of the discovered endoscopic lesions or the ability to treat most of these effectively over time. Improved prognostication of both patient characteristics and endoscopic lesion appearance with regard to bleeding behaviour, coupled with the impact of therapeutic deep enteroscopy, is now required using adapted, high-quality study methodologies.

Summary Background : The role of Helicobacter pylori in gastro-oesophageal reflux disease (GERD) is controversial. Aim : To compare the severity of GERD in infected vs. non-infected patients, as part of an ongoing randomized controlled trial that examines the impact of H. pylori eradication on GERD-related outcomes. Methods : Consecutive GERD patients underwent urea breath testing and completed validated GERD symptom severity, and quality of life questionnaires as well as, 24-h pH-metry. These parameters, as well as demographics and endoscopic findings were assessed in double-blinded fashion and compared between H. pylori-infected and non-infected subjects. Results : Helicobacter pylori-infected GERD patients (n = 50) were significantly older and less educated than non-infected patients (n = 51). They also used proton pump inhibitors less often but had no difference in symptoms (as measured with both the Spechler's Activity Index and the Gastrointestinal Symptom Rating Scale), quality of life, endoscopic findings or 24-h pH-metry findings. Conclusion : This prospective, double-blind study demonstrates, using excellent GERD quantifying measures including validated symptom severity scores, endoscopy, and 24-h pH-metry, that there exist no clinically significant differences in clinical or laboratory-related GERD manifestations between H. pylori-infected and non-infected GERD patients.

Sedation versus No Sedation in the Performance of Diagnostic Upper Gastrointestinal Endoscopy: A Canadian Randomized Controlled Cost-Outcome Study

The prevalence of H. pylori infection and PUD seem not to be different in CRF patients as compared with the general population. However, PUD in CRF patients seems to have some unique features-namely, lack of pain and higher associations with bleeding, with post-bulbar location, and with multiple ulcers. No increase in GERD has been proven in adults, but several studies demonstrate increased GERD in pediatric CRF patients. The causes of the increase in GERD may include delayed gastric emptying owing to altered myoelectric activity, or perhaps to an increased production of gastric acid, but evidence for the latter is small. Importantly, treating the problem may lead to better nutrition and higher albumin levels, thus improving patient prognosis.

PURPOSE: Toxic megacolon is a rare complication of pseudomembranous enterocolitis. We reviewed our recent experience with this complication. METHODS: The first five patients of the series were studied retrospectively, and six others were followed prospectively. RESULTS: Between June 1992 and May 1994, 11 patients (8 male, 3 female) developed toxic megacolon secondary to pseudomembranous enterocolitis. Mean age was 60.7 ±11.8 (range, 40–79) years. Presenting symptoms and signs included diarrhea, 100 percent; malaise, 91 percent; abdominal pain, 82 percent; abdominal distention, 82 percent; white blood cell count greater than 10.5, 82 percent; abdominal tenderness, 72 percent; anemia less than 12 gm, 72 percent; albumin less than 3 gm, 64 percent; tachycardia greater than 100, 55 percent; fever greater than 38.5‡ Celsius, 45 percent; shock or hypotension, 45 percent. Predisposing factors included antibiotics, 64 percent; immunosuppressants or chemotherapy, 36 percent; antidiarrheals, 27 percent; and barium enema in one patient. Five patients (45 percent) had more than one predisposing factor. X-rays showed transverse colon dilation and loss of haustrations in eight patients (72 percent), with a mean diameter of 99 ±3.4 cm. Flexible proctosigmoidoscopy showed pseudomembranes in all scoped patients, and toxin assay forClostridium difficile was positive in all patients. One patient had emergency surgery. Ten patients were initially treated medically with nasogastric suction and intravenous resuscitation (90 percent) and antibiotics (100 percent), usually in the intensive care unit (80 percent). Four patients did not respond and underwent surgery; two others improved, then deteriorated, and also underwent surgery. Altogether, 7 of 11 patients (64 percent) underwent surgery. Three patients (27 percent) responded well to medical treatment. One patient was deemed too ill to undergo surgery and died. Mean delay to surgery was 3.0 ±1.3 days. No sealed or overt perforation was found at laparotomy. All patients who underwent surgery had a subtotal colectomy, with either a Hartmann's stump (71 percent) or a mucous fistula (29 percent). Eventually, five of seven patients who were operated on and two of four medically treated patients died (overall mortality, 64 percent). Only one patient underwent closure of ileostomy and anastomosis. CONCLUSION: Toxic megacolon complicating pseudomembranous enterocolitis is a serious problem that carries a high morbidity and mortality rate, regardless of treatment.

SUMMARY Limited access to esophageal manometry (EM) may delay identification and treatment of patients with achalasia. In order to assess predictors to fast-track patients for manometric confirmation of achalasia, we compared the clinical, radiographic, and endoscopic characteristics of achalasia patients to patients with functional dysphagia without manometric features of achalasia (controls). Patients referred for esophageal manometry to assess functional dysphagia prospectively identified over a 12-month period were asked to participate in this study. The Achalasia Symptom Questionnaire (ASQ), a structured 11-question survey (score: 0–best, 67–worst), was completed by all consenting patients. ASQ scores, esophago-gastro-duodenoscopy and upper gastro-intestinal (UGI) contrast study findings were compared between patents with subsequently confirmed achalasia and those in whom achalasia was excluded by EM. Univariate logistic regression identified predictors that were tested by multivariate logistic regression to generate the model. Of the 803 EM performed over this 12-month period, 95 patients were referred specifically to assess functional dysphagia. Of these, 50 were confirmed to have achalasia, and 45 had dysphagia without manometric evidence for achalasia and hence comprised the control group. ASQ scores were higher in achalasia patients (37 ± 13 versus 23 ± 10). Endoscopy and/or contrast esophagogram reports were available in 92% achalasia patients and 80% controls. Significant predictors for achalasia identified on univariate logistic regression included ASQ score, abnormal findings on endoscopy, and contrast UGI study. Using multivariate logistic regression, we were able to accurately predict the probability of achalasia to be P where P = ey/(1 + ey) and y =−5.6 + (0.089 × ASQ) + (2.088 × EGD) + (3.083 × UGI), e = exponential constant 2.7182, esophagogastroduodenoscopy (EGD) and UGI = 0 if normal and 1 if abnormal. Dropping the predictor ASQ, the formula changes to y =−2.7 + (1.987 × EGD) + (2.861 × UGI). Using only noninvasive investigations (i.e. eliminating EGD), the formula changes to y =−4.9653 + (0.0951 × ASQ) + (3.4312 × UGI). The probability of achalasia can be calculated in patients with functional dysphagia based on clinical, endoscopic, and radiographic findings allowing for a prioritization of EM studies.

Pulmonary inflammatory myofibroblastic tumors are rare neoplasms of intermediate malignant potential. Most patients are asymptomatic and present with incidental findings on imaging. Dysphagia due to direct invasion into the esophagus is an extremely rare presentation of this uncommon tumor. The diagnosis is difficult to make preoperatively. Complete surgical resection offers the best chance of cure. We describe a 27-year-old man who presented with progressive dysphagia and the diagnosis was only revealed after en bloc resection of the esophagus, cardia, and left lower lobe.

Patients undergoing laparoscopic Nissen fundoplication (LNF) with paraesophageal hernias (PEH) are not only older and less healthy than those with gastroesophageal reflux disease (GERD), but in addition the repair is more complicated. We evaluated whether outcomes relating to GERD symptoms and quality of life (QOL) were impacted by the presence of PEH. Prospectively entered data from 149 patients (109 GERD and 40 PEH) were evaluated prior to and one year after LNF with standardized and validated symptoms scores. Scores for heartburn, dysphagia, disease-specific QOL (GERD-HRQL), and general health-related QOL (SF-12 physical and mental component scores) were compared between patients undergoing LNF for PEH or for GERD alone, at baseline and one year after surgery. p

The purpose of this study is to assess how subjective evaluation (heartburn, dysphagia, quality of life, and satisfaction) correlates with objective data after Heller myotomy and Dor fundoplication for achalasia.A total of 53 consecutive patients with achalasia undergoing laparoscopic Heller myotomy and Dor fundoplication were studied prospectively. Subjective evaluation was done preop and postop using the Gastroesophageal Reflux Disease Health-Related Quality of Life instrument (GERD-HRQL; 0 = best, 45 = worse), 4-point dysphagia and heartburn scales (0 = best, 3 = worst), patient satisfaction scale (0 = very satisfied, 5 = incapacitated), and the SF-12 general health-related quality-of-life score. At 3 months postop, patients were asked to undergo objective evaluation with 24-h pH testing, manometry, and endoscopy. Data are expressed as median (interquartile range) and analyzed by Wilcoxon signed rank test or Mann-Whitney U test.Forty-nine patients were more than 3 months postsurgery. Comparing preop to postop, improvements were found in dysphagia [3 (2-3) to 0 (0-1)], heartburn [1 (0-2) to 0 (0-1)], GERD-HRQL [13.5 (6.3-22.5) to 2 (0-5)], satisfaction [3 (3-4) to 1 (0-1)], and SF-12 mental component summary [46 (37-56) to 58 (50-59)] and physical component summary [46 (36-53) to 55 (48-56)] scores (p0.0001 for all). Thirty-eight patients (78%) agreed to undergo objective testing, and complete data were available for 32 (65%). Four of 32 patients (12.5%) had evidence of reflux based on 24-h pH testing. Of nine patients with GERD-HRQL5, only two had positive pH test (22%). Of 23 patients with GERD-HRQL5, two had positive pH test (7%). Of four tested patients with moderate to severe heartburn, two had an abnormal pH test. There was no significant relationship between GERD-HRQL score and pH test results. Lower esophageal sphincter pressure (LESP) decreased from 24 (16-35) to 13 mmHg (11-17) (p0.001). There was no relationship between dysphagia score and postop absolute LESP or a decrease in LESP after operation.Laparoscopic Heller myotomy and Dor fundoplication is an effective treatment for achalasia. Subjective evaluation can document patient satisfaction and health-related quality of life but does not accurately reflect postop reflux. Twenty-four-hour pH study is required to accurately assess reflux disease.

Purpose: This study reports the results of a single-institution experience with high-dose-rate brachytherapy (HDRBT) used as a boost in the treatment of esophageal cancer with external beam radiation therapy (ERT) with or without chemotherapy. Methods and Materials: Patients without evidence of metastatic disease were identified. HDRBT was given before ERT with a dose of 20 Gy in 5 fractions. Patients with a Karnofsky performance of more than 70 received treatment with 50 Gy in 25 fractions and concurrent 5-fluorouracil and cis-platinum during Weeks 1 and 5, whereas patients with a Karnofsky performance of less than 70 were treated with radiation therapy alone with 35 Gy in 14 fractions. Results: Fifty-three patients received HDRBT treatment with combined ERT and chemotherapy and 17 patients with ERT alone. The incidence of acute bone marrow toxicity was 55% Grade 2 and 15% Grade 3, and 85% of patients had Grade 2 esophagitis. With a median follow-up time of 26 months, the median survival was 21 months; the 2-year local recurrence was 25%, and the 5-year survival rate was 28%. Conclusion: HDRBT is safe and beneficial for local control in the radical treatment of patients with esophageal cancer.

Background Prior endoscopic studies evaluating conscious sedation have recruited only a small proportion of the patients actually approached. The generalizability of such results to an unselected adult ambulatory care population is thus questionable. The objectives of this study were to determine the characteristics of patients who refused inclusion in a randomized controlled trial of sedation and to compare these characteristics to those of patients who agreed to participate. Methods Patients who refused participation in a randomized controlled trial of sedation completed standardized questionnaires addressing demographic data and possible confounding variables, and they also completed a validated anxiety questionnaire. Characteristics associated with refusal to participate in the randomized controlled trial were assessed by using uni- and multivariate analysis. Exploratory comparisons of outcomes between both groups included self-reported satisfaction with level of comfort and technical adequacy. Results Of 302 patients screened, 203 refused to participate in the randomized controlled trial. The most common reason for refusal was the request for no sedation (135/203). A total of 163 were enrolled in this synchronous study. Patients who refused to participate exhibited 3 distinguishing characteristics: prior treatment for an anxiety disorder (risk difference 9.4%: 95% CI[3%, 17%]), use of analgesic medication (risk difference 10.4%: 95% CI[2%, 19%]), and prior experience with EGD (risk difference 17.9: 95% CI[5%, 30%]). Only upper endoscopy experience was predictive of refusal to participate in the randomized controlled trial. No differences in outcomes existed between patients randomized to sedation and those refusing the randomized controlled trial who chose to receive sedative medication. Patients who refused participation in the randomized controlled trial and who underwent upper endoscopy without sedation were more satisfied than patients randomized to placebo (1.33 vs. 2.58; risk difference −1.25: 95% CI[−0.38, −2.1]). Moreover, the procedure in these patients was more adequate technically (4.86 vs. 4.18; risk difference 0.68: 95% CI[0.21, 1.13]). Conclusions Characteristics of patients accepting and refusing randomization were highly similar, differing only with regard to upper endoscopy experience. An exploratory analysis of outcomes suggests that randomized controlled trial results may be biased in a direction that may underestimate the benefits of not administering sedative medication in a real-life setting.

The most appropriate approach to the repair of large paraesophageal hernias remains controversial. Despite early results of excellent outcomes after laparoscopic repair, recent reports of high recurrence require that this approach be reevaluated. For this study, 60 primary paraesophageal hernias consecutively repaired at one institution from 1990 to 2002 were reviewed. These 25 open transabdominal and 35 laparoscopic repairs were compared for operative, short-, and long-term outcomes on the basis of quality-of -life questionnaires and radiographs. No difference in patient characteristics was detected. Laparoscopic repair resulted in lower blood loss, fewer intraoperative complications, and a shorter length of hospital stay. No difference in general or disease-specific quality-of-life was documented. Radiographic follow-up was available for 78% open and 91% laparoscopic repairs, showing anatomic recurrence rates of 44% and 23%, respectively (p = 0.11). Laparoscopic repair should remain in the forefront for the management of paraesophageal hernias. However, there is considerable room for improvement in reducing the incidence of recurrence.

Background: Eliminating conscious sedation for diagnostic endoscopy may be advantageous for patient safety and cost containment. The aim of this study was to identify and validate independent predictors of a comfortable, technically adequate, unsedated diagnostic upper endoscopy in Canadian patients. Methods: Patients were consecutively enrolled in a prospective fashion. Data collected on an initial cohort of 268 patients included demographics, a validated anxiety questionnaire, use of sedatives/analgesics, upper endoscopy experience, pharyngeal sensitivity, technical adequacy, and patient assessment of comfort after the procedure. The main outcome measure was "satisfactory upper endoscopy," a composite of optimal scores for patient comfort and technical adequacy. Univariate and multivariate analyses were performed to identify the optimal predictive model of a satisfactory unsedated diagnostic upper endoscopy. Once identified, 68 additional patients were enrolled in a similar fashion from an independent prospective sample for purposes of outcome validation. Multivariate analysis was then repeated with the total cohort (N = 336). These results were then compared for concordance with those obtained from the initial cohort. Results: Among the initial 268 patients (54.3% women; mean age 51 ± 17 years), 49% were anxious, 15% regularly used sedatives and analgesics, 28% experienced increased pharyngeal sensitivity, and 41% had previously undergone upper endoscopy. Endoscopy was completed in 94.7% of patients without sedation and was technically adequate in 97%, and 80.1% were willing to repeat the procedure under similar conditions. Satisfactory upper endoscopy was achieved in only 59% of the initial cohort. The only independent and significant predictors of a satisfactory upper endoscopy were advancing age (OR 1.2: 95% CI [1.1, 1.4]) and decreased pharyngeal sensitivity (OR 0.5: 95% CI [0.27, 0.93]). Concordance of results were noted after validation with the second cohort. Satisfactory endoscopy was achieved in only 59.5% of the total cohort (n = 336); only 61% reported a comfortable procedural experience. Conclusions: The proportion of patients who can comfortably undergo technically adequate unsedated upper endoscopy is modest. Unsedated upper endoscopy is most likely to be successful under these procedural conditions in patients of advancing age with decreased pharyngeal sensitivity. The generalizability of these findings to an American population requires further study and may assist in identifying a subgroup of patients in whom it is cost-effective to perform upper endoscopy comfortably without sedation. (Gastrointest Endosc 2002;56:180-9.)

Background. Surgical success has traditionally been judged from the surgeon's perspective. A more complete evaluation of outcome incorporates the patient's, surgeon's, and payor's perspectives. Because gastroesophageal reflux disease (GERD) is primarily a quality-of-life (QOL) problem, the evaluation of laparoscopic fundoplication (LF) is a useful model for evaluating outcomes from these 3 perspectives. Methods. Between 1995 and 2000, 74 patients underwent primary LF for GERD. In addition to undergoing physiologic testing, 63 patients (85%) were evaluated with use of a disease-specific health-related QOL scale (GERD-HRQL), scored from 0 (no symptoms) to 45 (incapacitating symptoms). Thirty-three patients also completed a generic QOL questionnaire (SF-12), in which patient satisfaction was scored from 1 (very satisfied) to 5 (very dissatisfied). Preoperative and postoperative data were compared with use of the Wilcoxon signed rank test or the paired t test. Results. The median GERD-HRQL score improved from 18 to 0 at 2 years postoperation (P

OBJECTIVES: A recent report has suggested an association between Helicobacter pylori eradication and the development of gastroesophageal reflux disease (GERD). We therefore assessed the incidence of GERD among comparable patients having undergone successful versus failed H. pylori eradication in a controlled trial. We also compared the H. pylori strains in the subjects that developed GERD to those that did not. METHODS: Patients with a history of proven duodenal ulcer and H. pylori infection were randomised into a H. pylori eradication study. Patients subsequently underwent gastroscopy with gastric biopsies every 3 months for 1 yr. At each visit, the presence of GERD symptoms and endoscopic esophagitis were noted, and the incidence of these variables among patients in whom H. pylori eradication was successful was compared to those in whom it was not. In a subgroup, the presence of the cagA, cagE, and vacA genotypes and of cagA antibodies were determined. RESULTS: Of 98 patients randomized into this study, 11 dropped out before determination of H. pylori eradication, leaving 87 patients with analyzable results. H. pylori eradication was successful in 63 (72%). By the end of the follow-up period, patients with GERD symptoms or endoscopic esophagitis were more prevalent in the successful than in the failed eradication group (37% [95% CI: 25–50%] vs 13% [95% CI: 3–32%], p = 0.04, 95% CI for the difference: 6–42%), as were patients with GERD symptoms alone (29% [95% CI: 18–41%] vs 8% [95% CI: 1–27%], p = 0.04, 95% CI for the difference: 4–36%) or esophagitis alone (21% [95% CI: 12–33%] vs 4% [95% CI: 0–21%], p = 0.10, 95% CI for the difference: 4–29%, respectively). Multivariate analysis revealed no significant association between the incidence of symptoms or esophagitis and age, gender, Quetelet index, caffeine or alcohol intake, smoking, weight change, or the presence of a hiatus hernia. There were also no differences in the prevalence of H. pylori genotypes from patients who developed GERD as compared to those who did not. CONCLUSIONS: In this patient population, the incidence of new GERD-type symptoms or endoscopic esophagitis was greater in patients in whom successful eradication was achieved. This difference does not appear to be attributable to weight gain, habits, or specific H. pylori strains.

Background: Videocapsule endoscopy (VCE), when compared to enteroscopy (E), is associated with increased detection of mucosal lesions in obscure gastrointestinal bleeding (OGB). However, few randomized trials have compared these two modalities, and data on clinical relevance are lacking. The aim of this study was to compare VCE with E in terms of diagnostic yield and subsequent clinical outcome. Methods: We randomly allocated adult patients with occult bleeding (iron deficiency anemia >6 months needing blood transfusion or iron supplementation with repeated positive stool occult blood testing) or overt bleeding (≥1episode of melena/hematochezia within 7 days of presentation and a hemoglobin drop ≥15 g/dL) to VCE or E after a negative initial work-up (single or repeated gastroscopy and colonoscopy examinations with or without small bowel radiology). The main outcomes were recurrence and persistence of bleeding using standardized criteria defined a priori over 1year. Crossovers were permitted after the main outcome was reached. Results: 79 patients (68.5±14.5yrs, 36.7% female) were included over a 5-year period. 40 subjects were allocated to VCE and 39 to E (of push type). Overall, 76.0% presented with overt bleeding. At baseline, 24.1% were taking ASA, 11.4% an anticoagulant, and 2.5% an NSAID; 76.7% of patients had a nuclear scan, and 37.0% an angiography. No significant differences were noted in baseline characteristics between the two groups. At least one lesion was detected in 72.5% of the VCE group compared to 48.7% in the E group (p=0.03); they were believed to be the source of bleeding in 79.3% and 35.0% (p=0.002), respectively. Although detection rates were similar for gastric and duodenal findings, VCE performed better in the first and second parts of the jejunum (50% vs. 10.3% P=0.0001, and 40% vs. 2.6% P

Background: Conventional perfused manometry has led to extensive study of phasic contractile activity in the human esophagus, but little is known about esophageal tonic activity. The aims of this study were to assess esophageal smooth and striated muscle tone and the effect of a smooth muscle relaxant (amyl nitrite, 0.3 mL inhalation) on this tone. Methods: Using a computerized isobaric recording system (barostat), esophageal tonic activity in 13 healthy subjects was recorded. Two parameters were analyzed: compliance and resistance to initial stretch (resting tone). Results: The smooth muscle esophagus was significantly more compliant but presented a greater resistance to initial stretch than the striated muscle section. Amyl nitrite affected only the smooth muscle section, significantly increasing compliance and decreasing the resistance to initial stretch. Significant chest pain and/or discomfort occurred only during striated muscle esophagus distension (10 of the 13 subjects at 25 mm Hg distending pressure). Conclusions: Active tone is present in the smooth muscle esophagus and can be modulated by a smooth muscle relaxant. Compliance and resting tone differ between the smooth and striated muscle segments of the esophagus. Assessment of tone in patients with esophageal motor disorders and noncardiac chest pain should provide further insights into these disorders.

Background: Previously we have identified that patients over the age of 55 or with decreased pharyngeal sensitivity could best tolerate gastroscopy without sedation.We hypothesized that the absence of sedation in the performance of a diagnostic gastroscopy in this sub-group would be more costeffective. The present analysis includes the interim results of the effectiveness component of this RCT. Methods: A prospective randomized controlled double blind trial assigned patients to undergo gastroscopy with the use of standard sedation vs. placebo. The main outcome measure was "satisfactory endoscopy", a composite score of the physician's rating of technical adequacy and the patient's satisfaction with the procedure immediately and 24-48 hours later. Possible confounders were noted including demographics (age, gender, race), previous experience with endoscopy, expectations of endoscopy, medication consumption and a validated anxiety questionnaire. Univariate and multivariate analysis was completed. Results were considered significant when the confidence interval on the difference between two proportions did not include 0. Results: 100 patients were enrolled, with 50 randomized to each group (A= active meds , B=placebo). Both groups were similar for all baseline variables except for age (48.1± 14.9 yrs vs. 58.5 ± 17.1 yrs) and percent of females (60% vs. 36%; CI: 4.04 to 42.3). Patients of group A were significantly more comfortable (1= Acceptable, 5=Unacceptable) than those in group B (1.62 ± 0.92 vs. 2.58 ± 1.14 ; CI: -1.37 to -0.55). 86% of group A were willing to repeat their procedure under similar conditions vs. only 60% of group B (CI: 0.16 to 0.47). Technical adequacy was similar between the two groups. Multivariate analysis revealed that randomization to active medication was the only independent significant variable with regards to patient satisfaction and willingness to repeat the procedure. No differences exist to date in the subgroup of patients over age 55 with decreased pharyngeal sensitivity. Conclusions: The use of sedation in the performance of gastroscopy results in superior patient comfort, tolerance, satisfaction and willingness to repeat the procedure. Further accrual is required to achieve sufficient power for a valid subgroup analysis. The costs of each approach also requires further characterization.

BACKGROUND: A common criticism of previous studies evaluating the use of sedation in the performance of upper gastrointestinal endoscopy, is the inevitable selection bias in patient recruitment. Previous studies (when such data is available) have recruited