Less Is More: A Minimalist Approach to Endoscopy.

A substantial literature documents inappropriate usage of gastrointestinal endoscopy in a variety of clinical settings. Overusage of endoscopy appears to be common, and 30% or more of procedures performed in some clinical settings have questionable indications. The potential reasons for overuse of endoscopy are multiple, and include cancer phobia, fear of medical malpractice litigation, profit motive, the investigation of "incidentalomas" found on other imaging, and underappreciation of the delayed harms of endoscopy, among other reasons. Clinical guidelines, which should limit overuse of endoscopy, may instead serve to promote it, if authors opt to be "conservative," recommending endoscopy in situations of unclear utility. Several strategies may decrease overuse of endoscopy, including careful attention to risk stratification when choosing patients to screen, adherence to guidelines for surveillance intervals for colonoscopy, the use of quality indicators to identify outliers in endoscopy utilization, and education on appropriate indications and the risks of overuse at the medical student, residency, and fellowship levels.

BOB CAT: A Large-Scale Review and Delphi Consensus for Management of Barrett's Esophagus With No Dysplasia, Indefinite for, or Low-Grade Dysplasia.

OBJECTIVES: Barrett's esophagus (BE) is a common premalignant lesion for which surveillance is recommended. This strategy is limited by considerable variations in clinical practice. We conducted an international, multidisciplinary, systematic search and evidence-based review of BE and provided consensus recommendations for clinical use in patients with nondysplastic, indefinite, and low-grade dysplasia (LGD). METHODS: We defined the scope, proposed statements, and searched electronic databases, yielding 20,558 publications that were screened, selected online, and formed the evidence base. We used a Delphi consensus process, with an 80% agreement threshold, using GRADE (Grading of Recommendations Assessment, Development and Evaluation) to categorize the quality of evidence and strength of recommendations. RESULTS: In total, 80% of respondents agreed with 55 of 127 statements in the final voting rounds. Population endoscopic screening is not recommended and screening should target only very high-risk cases of males aged over 60 years with chronic uncontrolled reflux. A new international definition of BE was agreed upon. For any degree of dysplasia, at least two specialist gastrointestinal (GI) pathologists are required. Risk factors for cancer include male gender, length of BE, and central obesity. Endoscopic resection should be used for visible, nodular areas. Surveillance is not recommended for <5 years of life expectancy. Management strategies for indefinite dysplasia (IND) and LGD were identified, including a de-escalation strategy for lower-risk patients and escalation to intervention with follow-up for higher-risk patients. CONCLUSIONS: In this uniquely large consensus process in gastroenterology, we made key clinical recommendations for the escalation/de-escalation of BE in clinical practice. We made strong recommendations for the prioritization of future research.

Consensus statements for management of Barrett's dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process.

BACKGROUND & AIMS: Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA. METHODS: We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement. RESULTS: Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated. CONCLUSIONS: We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies.

Radiofrequency ablation in Barrett's esophagus with dysplasia.

BACKGROUND: Barrett's esophagus, a condition of intestinal metaplasia of the esophagus, is associated with an increased risk of esophageal adenocarcinoma. We assessed whether endoscopic radiofrequency ablation could eradicate dysplastic Barrett's esophagus and decrease the rate of neoplastic progression. METHODS: In a multicenter, sham-controlled trial, we randomly assigned 127 patients with dysplastic Barrett's esophagus in a 2:1 ratio to receive either radiofrequency ablation (ablation group) or a sham procedure (control group). Randomization was stratified according to the grade of dysplasia and the length of Barrett's esophagus. Primary outcomes at 12 months included the complete eradication of dysplasia and intestinal metaplasia. RESULTS: In the intention-to-treat analyses, among patients with low-grade dysplasia, complete eradication of dysplasia occurred in 90.5% of those in the ablation group, as compared with 22.7% of those in the control group (P<0.001). Among patients with high-grade dysplasia, complete eradication occurred in 81.0% of those in the ablation group, as compared with 19.0% of those in the control group (P<0.001). Overall, 77.4% of patients in the ablation group had complete eradication of intestinal metaplasia, as compared with 2.3% of those in the control group (P<0.001). Patients in the ablation group had less disease progression (3.6% vs. 16.3%, P=0.03) and fewer cancers (1.2% vs. 9.3%, P=0.045). Patients reported having more chest pain after the ablation procedure than after the sham procedure. In the ablation group, one patient had upper gastrointestinal hemorrhage, and five patients (6.0%) had esophageal stricture. CONCLUSIONS: In patients with dysplastic Barrett's esophagus, radiofrequency ablation was associated with a high rate of complete eradication of both dysplasia and intestinal metaplasia and a reduced risk of disease progression. (ClinicalTrials.gov number, NCT00282672.)

4-Liter split-dose polyethylene glycol is superior to other bowel preparations, based on systematic review and meta-analysis.

BACKGROUND & AIMS: Adequate bowel cleansing is an important determinant of the efficacy of screening colonoscopy. Polyethylene glycol (PEG)-based solutions are used commonly in bowel preparation, but their poor palatability and large volumes (4 L) influence compliance. Adjunct therapies, such as bisacodyl, split-dose regimens, and lower-volume regimens have been tested. We performed a meta-analysis to determine whether a 4-L split dose of PEG is better than others for bowel cleansing before colonoscopy. METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Database, recent abstracts from major conference proceedings, references from selected reviews and randomized trials (http://clinicaltrials.gov), and Google Scholar, through September 2011, for high-quality, randomized trials that compared 4-L split-dose PEG without adjunct therapy with other bowel preparation methods. Nine of 2477 trials considered were used in the analysis. We calculated pooled estimates of bowel preparation quality (primary outcome: excellent or good), preparation compliance, favorable overall experiences, willingness to repeat same preparation, and side effects. We calculated pooled estimates of odds ratios by fixed- and random-effects models. We also assessed heterogeneity among studies and publication bias. RESULTS: The overall pooled odds ratio for excellent or good bowel preparation quality for 4-L split-dose PEG was 3.46, compared with other methods (95% confidence interval, 2.45-4.89; P < .01). Although there was significant heterogeneity in results among studies, 7 of 9 reported a significant benefit from the 4-L split-dose PEG preparation. There were no significant differences between PEG and others in preparation compliance, favorable overall experience, willingness to repeat the same preparation, abdominal cramping, nausea, or sleep disturbance. There was no significant publication bias based on funnel plot. CONCLUSIONS: A meta-analysis showed that 4-L split-dose PEG is better than other bowel preparation methods for colonoscopy. Significant heterogeneity among studies might result from differences in patient demographics and protocols. A 4-L split dose of PEG should be considered the standard with which new bowel preparation methods are compared.

Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

BACKGROUND & AIMS: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE. METHODS: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events. RESULTS: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years). CONCLUSIONS: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.

Warm water infusion during sedated colonoscopy does not decrease amount of sedation medication used.

BACKGROUND: Water infusion versus air insufflation during colonoscope insertion has been suggested to reduce patient discomfort and decrease sedation medication requirements. Warm water is thought to further facilitate colonoscopy perhaps by decreasing colon spasm. OBJECTIVE: To compare the utility of warm (35°-38°C) versus cool (20°-23°C) water infused during colonoscopic insertion by measuring patient sedation medication use and discomfort scores between the warm and cool water groups. DESIGN: Randomized, controlled, double-blinded study. SETTING: Outpatient endoscopy unit at an academic medical center. PATIENTS: A total of 175 adults. INTERVENTION: Elective outpatient sedated screening colonoscopies. MAIN OUTCOME MEASUREMENTS: Sedation medication used, pain scores, cecal intubation rate, endoscopy times, satisfaction scores, and patient willingness to repeat procedures. RESULTS: There was no significant difference in sedation medication requirement during colonoscopy with the use of warm or cool water (fentanyl 83.6 ± 29.0 µg vs 87.6 ± 39.6 µg; P = .45; midazolam 3.3 ± 1.2 mg vs 3.3 ± 1.3 mg; P = .91). There was no significant difference in patient pain scores or satisfaction scores. Cecal intubation rates (100%) were similar. There was no significant difference in cecal intubation times (6 minutes 40 seconds ± 4 minutes 9 seconds vs 7 minutes 49 seconds ± 4 minutes 0 seconds; P = .06) between the warm and cool water groups. All patients were willing to repeat the colonoscopy by using the same method in both groups. LIMITATIONS: Limited generalizability to patients undergoing screening sedated colonoscopies with good to excellent bowel preparation. CONCLUSION: Water does not need to be warmed before infusion in patients undergoing sedated colonoscopies.

Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: a prospective multicenter observational cohort study.

BACKGROUND: There are few comparative data as to whether plastic or self-expanding metallic stents are preferable for palliating malignant hilar biliary obstruction. METHODS: Thirty-day outcomes of consecutive endoscopic retrograde cholangiopancreatographies performed for malignant hilar obstruction at 6 private and 5 university centers were assessed prospectively. RESULTS: Patients receiving plastic (N=28) and metallic stents (N=34) were similar except that metallic stent recipients more often had: Bismuth III or IV tumors (16/34 vs. 5/28 P=0.043), higher Charlson comorbidity scores (P=0.003), metastatic disease (P=0.006), and management at academic centers (P=0.018). The groups had similar rates of bilateral stent placement (4/28 vs. 5/34), and similar frequency of opacified but undrained segmental ducts (7/28 vs. 5/34). Adverse outcomes including cholangitis, stent occlusion, migration, perforation, and/or the need for unplanned endoscopic retrograde cholangiopancreatography or percutaneous transhepatic cholangiography occurred in 11/28 (39.3%) patients with plastic versus 4/34 (11.8%) with metal stents (P=0.017). By logistic regression, factors associated with adverse outcomes included plastic stent placement (odds ratio 6.32; 95% confidence interval 1.23, 32.56) and serum bilirubin (1.11/mg/dL above normal: 1.01, 1.22) but not center type or Bismuth class. CONCLUSIONS: Metallic stent performance was superior to plastic for hilar tumor palliation with respect to short-term outcomes, independent of disease severity, Bismuth class, or drainage quality.

Can the clinical history distinguish between organic and functional dyspepsia?

CONTEXT: Upper gastrointestinal symptoms occur in 40% of the population. An accurate diagnosis would help rationalize investigation and treatment. OBJECTIVE: To systematically review the literature of the accuracy of primary care physicians, gastroenterologists, or computer models in diagnosing organic dyspepsia. DATA SOURCES: A search of Cochrane Controlled Trials Register (December 2003), MEDLINE (1966-December 2003), EMBASE (1988-December 2003), and CINAHL (1982-December 2003) for studies that reported on cohorts of patients attending for endoscopy that had symptoms, clinical opinion, or both recorded before investigation. STUDY SELECTION: Studies that prospectively compared the diagnosis reached by a clinician, computer model, or both with results of upper gastrointestinal endoscopy in adult patients with upper gastrointestinal symptoms. DATA EXTRACTION: Two authors independently assessed studies (n = 79) for eligibility and abstracted data for estimating likelihood ratios (LRs) of clinical opinion, computer models, or both in diagnosing an organic cause for dyspepsia. DATA SYNTHESIS: Fifteen studies were identified that evaluated 11 366 patients, with 4817 patients (42%) classified as having organic dyspepsia. The computer models performed similarly to the clinician; therefore, the 2 approaches were combined. The diagnosis reached by the clinician or computer model suggesting organic dyspepsia had an LR of 1.6 (95% confidence interval [CI], 1.4-1.8), and a negative result decreased the likelihood of organic dyspepsia (LR, 0.46; 95% CI, 0.38-0.55). A diagnosis of peptic ulcer disease performed similarly with an LR of 2.2 (95% CI, 1.9-2.6), but an evaluation that suggested the absence of peptic ulcer disease had an LR of 0.45 (95% CI, 0.38-0.53). A clinical history suggesting esophagitis had an LR of 2.4 (95% CI, 1.9-3.0) vs a negative history that had an LR of 0.50 (95% CI, 0.42-0.60). CONCLUSION: Neither clinical impression nor computer models that incorporated patient demographics, risk factors, history items, and symptoms adequately distinguished between organic and functional disease in patients referred for endoscopic evaluation of dyspepsia.

Heartburn severity does not predict disease severity in patients with erosive esophagitis.

BACKGROUND: For patients with gastroesophageal reflux disease (GERD), it is often assumed by treating physicians that the severity of heartburn correlates with the severity of erosive esophagitis (EE). OBJECTIVE: This is a post hoc analysis of data from 5 clinical trials that investigate the relationship between the baseline severity of heartburn and the baseline severity of EE. METHODS: Patients with endoscopically confirmed EE were assessed for heartburn symptoms with a 4-point scale at baseline and during treatment for 8 weeks with various proton pump inhibitors in 5 double-blind trials in which esomeprazole was the common comparator. EE was graded with the Los Angeles (LA) classification system. In these trials, healing and symptom response were evaluated by endoscopy and questionnaire after 4 weeks of treatment. Patients who were not healed were treated for an additional 4 weeks and reevaluated. RESULTS: A total of 11,945 patients with endoscopically confirmed EE participated in the 5 trials, with patients receiving esomeprazole 40 mg (n = 5068), esomeprazole 20 mg (n = 1243), omeprazole 20 mg (n = 3018), or lansoprazole 30 mg (n = 2616). Approximately one quarter of the 11,945 GERD patients in these 5 trials had severe EE (defined as LA grades C or D), regardless of their baseline heartburn severity. CONCLUSION: The severity of GERD symptoms does not correlate well with disease severity. These findings indicate that endoscopy may have value in GERD patients in identifying those with EE, and if empirical therapy is chosen, then longer courses (4-8 weeks) of antisecretory therapy may be necessary to ensure healing of unrecognized esophagitis.

Forty-eight-hour pH monitoring increases sensitivity in detecting abnormal esophageal acid exposure.

Ambulatory 24-hour esophageal pH measurement is the standard for detecting abnormal esophageal acid exposure (AEAE), but it has a false negative rate of 15% to 30%. Wireless 48-hour pH monitoring (Bravo; Medtronic, Shoreview, MN) may allow more accurate detection of AEAE versus 24-hour pH monitoring. Forty-eight-hour wireless data were reviewed from 209 patients at three different tertiary care referral centers between 2003 and 2005. Manometric or endoscopic determination of the lower esophageal sphincter helped place the Bravo probe 5 to 6 cm above the lower esophageal sphincter. A total of 190 studies in 186 patients had sufficiently accurate data. There were 114 women and 72 men with an average age of 51 years. AEAE was defined by a Johnson-DeMeester score greater than 14.7 and was obtained in 115 of 190 studies (61%). Only 64 of 115 patients (56%) demonstrated AEAE for both days of the study, whereas 51 of 115 patients (44%) demonstrated AEAE in a single 24-hour period. There was no difference in the prevalence of AEAE on day 1 versus day 2 only (26% vs. 18%, P = .26). Compared with 24-hour alone data, 48-hour data showed 22% more patients with AEAE. Frequent day-to-day variability in patients with AEAE may be missed by a single 24-hour pH test. Forty-eight-hour pH testing may increase detection accuracy and sensitivity for AEAE by as much as 22%.

Helicobacter pylori: why it still matters in 2005.

Despite falling prevalence rates in the developed world, H pylori is still present in the United States and is particularly prevalent among racial minorities and recent immigrants. H pylori infection is clearly associated with an increased risk of peptic ulcer disease, gastric cancer, and MALT lymphoma, and it is associated with some cases of uninvestigated dyspepsia. Identification and eradication of H pylori improves outcomes in patients with peptic ulcer disease and causes tumor regression in patients with MALT lymphoma. It is uncertain whether H pylori eradication will improve outcomes in patients with gastric cancer. Decision analytic models suggest that a test-and-treat strategy for H pylori is rational and cost-effective for patients with uninvestigated dyspepsia.

Traditional therapies for irritable bowel syndrome: an evidence-based appraisal.

Irritable bowel syndrome (IBS) is a common chronic disease that adversely effects quality of life and is associated with substantial direct and indirect health care costs. It is defined by a constellation of symptoms in conjunction with an alteration in bowel function and defecation, and its underlying pathophysiological basis remains unknown. Numerous therapies are available, but many relieve only one symptom of the syndrome, and their effectiveness has not been demonstrated with adequate evidence from high-quality studies. This article reviews the criteria for appropriate design of any treatment study as well as those criteria specific to studies of treatment for functional gastrointestinal diseases. Using these criteria, the author evaluates the published investigations of "traditional" IBS therapies (antidepressants, bulking agents/fiber, antispasmodics, antidiarrheals) and "alternative" IBS therapies (Chinese herbal supplements, peppermint oil, behavioral therapies). Based on this evaluation, the author concludes that the available evidence does not support the effectiveness of any of these treatments and, therefore, none of these treatments can be reliably recommended.