Novel Use for Maloney Dilators in the Management of Gastrostomy Stenosis.

Gastrostomy tube dislodgement is a common complication after gastrostomy tube placement. If the tube is not immediately replaced, the gastrostomy stomal tract may close in as little as 8 hours. Small case series have reported the salvage of partially closed or stenosed gastrostomy stomal tracts using different types of dilators, but the use of Maloney dilators for this indication has not been reported. Dilation of a stenosed tract can allow for immediate re-establishment of enteral access without the need for a repeat invasive procedure. We present 3 instances of gastrostomy stenosis successfully dilated with Maloney dilators using minimal topical anesthesia.

Understanding Systematic Reviews and Meta-Analyses [Formula: see text].

Systematic reviews should be distinguished from narrative reviews. In the latter, an editor asks an expert to sum up all of the information that is known about a particular topic. However, the expert is under no constraints regarding what he or she does, or does not, choose to include in the review. As a result, his or her bias can influence the final message. A systematic review, which may or may not be written by experts, typically asks a narrower question, and then answers it using the entirety of the medical literature. The systematic review process includes computer searches to identify the pertinent literature, a statement of the inclusion and exclusion criteria for identified studies, a list of items of interest to extract from each study, a method to assess the quality of each study, a summary of the evidence that has been found (which may or may not involve attempts to combine data), a discussion of the evidence and the limitations of the conclusions, and suggestions for future research efforts. If the data are combined, that process is called meta-analysis. In meta-analysis, an estimate of the reliability of each study is made, and those that appear to be more reliable are weighed more heavily when the data are combined. While systematic reviews depend on a more preplanned method and thus, unlike narrative reviews, contain sections on method, they can be easily read once the reader becomes familiar with the vocabulary.

The presence and effect of bias in trials of early enteral nutrition in critical care.

BACKGROUND: Randomized trials suggest that early enteral nutrition is beneficial in critically ill adults. However, methodologic bias can overestimate benefit. OBJECTIVE: To assess the potential effect of methodologic bias on these trials. STUDY DESIGN: Systematic review and meta-analysis. DATA SOURCE: Randomized trials identified in electronic searches of PUBMED, EMBASE, and the Cochrane Library, and in various handsearches. METHODS: The primary (mortality, morbidity) and secondary (time on ventilator or in intensive care unit/hospital, cost) outcomes were abstracted from each identified trial comparing early enteral nutrition to no/delayed enteral nutrition. Each trial was assessed for six domains of methodologic bias (sequence generation, allocation concealment, blinding, intention-to-treat, selective outcome reporting, other). No low risk of bias trial (adequate in all six domains) was identified, so such trials could not be compared to the others. Instead, meta-analyses of trials with more or fewer risks were compared in the following ways: adequate methodology to deal with ≥3 or ≤2 domains; Jadad scores ≥3 or ≤2; adequate versus not adequate for each domain. DATA SYNTHESIS: In the 15 identified trials, early enteral nutrition appeared to improve mortality and infectious morbidity. Mortality benefit was observed only in trials with more risks of bias; infectious morbidity benefit was observed in some analyses of trials with fewer bias risks. LIMITATIONS: Small numbers of trials and missing information. CONCLUSIONS: The benefits attributed to early enteral nutrition were either seen only in trials with high risks of bias or may result from residual risks of bias.

Critical reading and critical thinking--study design and methodology: a personal approach on how to read the clinical literature.

The volume of medical literature grows exponentially. Yet we are faced with the necessity to make clinical decisions based on the availability and quality of scientific information. The general strength (reliability, robustness) of any interpretation that guides us in clinical decision making is dependent on how information was obtained. All information and medical studies and, consequently, all conclusions are not created equal. It is incumbent upon us to be able to assess the quality of the information that guides us in the care of our patients. Being able to assess medical literature critically requires use of critical reading and critical thinking skills. To achieve these skills, to be able to analyze medical literature critically, takes a combination of education and practice, practice, and more practice.

Nutritional support for liver disease.

BACKGROUND: Weight loss and muscle wasting are commonly found in patients with end-stage liver disease. Since there is an association between malnutrition and poor clinical outcome, such patients (or those at risk of becoming malnourished) are often given parenteral nutrition, enteral nutrition, or oral nutritional supplements. These interventions have costs and adverse effects, so it is important to prove that their use results in improved morbidity or mortality, or both. OBJECTIVES: To assess the beneficial and harmful effects of parenteral nutrition, enteral nutrition, and oral nutritional supplements on the mortality and morbidity of patients with underlying liver disease. SEARCH METHODS: The following computerised databases were searched: the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, and Science Citation Index Expanded (January 2012). In addition, reference lists of identified trials and review articles and Clinicaltrials.gov were searched. Trials identified in a previous systematic handsearch of Index Medicus were also considered. Handsearches of a number of medical journals, including abstracts from annual meetings, were done. Experts in the field and manufacturers of nutrient formulations were contacted for potential references. SELECTION CRITERIA: Randomised clinical trials (parallel or cross-over design) comparing groups of patients with any underlying liver disease who received, or did not receive, enteral or parenteral nutrition or oral nutritional supplements were identified without restriction on date, language, or publication status. Six categories of trials were separately considered: medical or surgical patients receiving parenteral nutrition, enteral nutrition, or supplements. DATA COLLECTION AND ANALYSIS: The following data were sought in each report: date of publication; geographical location; inclusion and exclusion criteria; the type of nutritional support and constitution of the nutrient formulation; duration of treatment; any nutrition provided to the controls; other interventions provided to the patients; number, sex, age of the study participants; hospital or outpatient status; underlying liver disease; risks of bias (sequence generation, allocation concealment, blinding, incomplete outcome reporting, intention-to-treat analysis, selective outcome reporting, others (vested interests, baseline imbalance, early stopping)); mortality; hepatic morbidity (development or resolution of ascites or hepatic encephalopathy, occurrence of gastrointestinal bleeding); quality of life scores; adverse events; infections; lengths of stay in the hospital or intensive care unit; costs; serum bilirubin; postoperative complications (surgical trials only); and nutritional outcomes (nitrogen balance, anthropometric measurements, body weight). The primary outcomes of this review were mortality, hepatic morbidity, quality of life, and adverse events. Data were extracted in duplicate; differences were resolved by consensus.Data for each outcome were combined in a meta-analysis (RevMan 5.1). Estimates were reported using risk ratios or mean differences, along with the 95% confidence intervals (CI). Both fixed-effect and random-effects models were employed; fixed-effect models were reported unless one model, but not the other, found a significant difference (in which case both were reported). Heterogeneity was assessed by the Chi(2) test and I(2) statistic. Subgroup analyses were planned to assess specific liver diseases (alcoholic hepatitis, cirrhosis, hepatocellular carcinoma), acute or chronic liver diseases, and trials employing standard or branched-chain amino acid formulations (for the hepatic encephalopathy outcomes). Sensitivity analyses were planned to compare trials at low and high risk of bias and trials reported as full papers. The following exploratory analyses were undertaken: 1) medical and surgical trials were combined for each nutritional intervention; 2) intention-to-treat analyses in which missing dichotomous data were imputed as best- and worst-case scenarios; 3) all trials were combined to assess mortality; 4) effects were estimated by absolute risk reductions. MAIN RESULTS: Thirty-seven trials were identified; only one was at low risk of bias. Most of the analyses failed to find any significant differences. The significant findings that were found were the following: 1) icteric medical patients receiving parenteral nutrition had a reduced serum bilirubin (mean difference (MD) -2.86 mg%, 95% CI -3.82 mg% to -1.89 mg%, 3 trials) and better nitrogen balance (MD 3.60 g/day, 95% CI 0.86 g/day to 6.34 g/day, 1 trial); 2) surgical patients receiving parenteral nutrition had a reduced incidence of postoperative ascites only in the fixed-effect model (RR 0.65, 95% CI 0.48 to 0.87, 2 trials, I(2) = 70%) and one trial demonstrated a reduction in postoperative complications, especially infections (pneumonia in particular); 3) enteral nutrition may have improved nitrogen balance in medical patients (although a combination of the three trials was not possible); 4) one surgical trial of enteral nutrition found a reduction in postoperative complications; and 5) oral nutritional supplements had several effects in medical patients (reduced occurrence of ascites (RR 0.57, 95% CI 0.37 to 0.88, 3 trials), possibly (significant differences only seen in the fixed-effect model) reduced rates of infection (RR 0.49, 95% CI 0.24 to 0.99, 3 trials, I(2) = 14%), and improved resolution of hepatic encephalopathy (RR 3.75, 95% CI 1.15 to 12.18, 2 trials, I(2) = 79%). While there was no overall effect of the supplements on mortality in medical patients, the one low risk of bias trial found an increased risk of death in the recipients of the supplements. Three trials of supplements in surgical patients failed to show any significant differences. No new information was derived from the various subgroup or sensitivity analyses. The exploratory analyses were also unrevealing except for a logical conundrum. There was no difference in mortality when all of the trials were combined, but the trials of parenteral nutrition found that those recipients had better survival (RR 0.53, 95% CI 0.29 to 0.98, 10 trials). Either the former observation represents a type II error or the latter one a type I error. AUTHORS' CONCLUSIONS: The data do not compellingly justify the routine use of parenteral nutrition, enteral nutrition, or oral nutritional supplements in patients with liver disease. The fact that all but one of these trials were at high risks of bias even casts doubt on the few benefits that were demonstrated. Data from well-designed and executed randomised trials that include an untreated control group are needed before any such recommendation can be made. Future trials have to be powered adequately to see small, but clinically important, differences.

Celiac disease in an urban VA population with iron deficiency: the case against routine duodenal biopsy.

BACKGROUND: Celiac disease is considered an under-recognized cause of iron deficiency. Small intestinal biopsy is proposed to be part of routine evaluation for iron deficiency. AIMS: To determine the prevalence of celiac disease in an urban, mostly male, mostly minority population with iron deficiency. METHODS: Clinical, endoscopic, and pathologic records of veterans who had undergone esophagogastroduodenoscopy (EGD) and duodenal biopsy for iron deficiency at an urban, tertiary care Veterans Affairs Medical Center were reviewed. The yield of positive duodenal biopsies for celiac disease and pre-defined clinically important findings on EGD were calculated. Confounding factors were assessed in multivariate analysis. The main outcome measures were prevalence of celiac disease and prevalence of clinically important findings on upper gastrointestinal endoscopy. RESULTS: The records of 310 veterans were reviewed. Mean age was 63, range 32-91 years old. Most were male (89%) and African-American (73%). Five of 306 small intestinal biopsies were consistent with celiac disease (type 1 lesions), but tissue transglutaminase obtained in four of the patients was normal, making the prevalence of potential celiac disease 0.33% (95% CI: 0.06-1.83%). Fifty of 310 EGDs demonstrated findings that were considered to have a moderate or high probability of producing iron deficiency (16.1, 95% CI: 12.5-20.6%). CONCLUSIONS: The prevalence of celiac disease is low in an urban, predominately male, African-American population with iron deficiency. Routine small intestinal biopsy for celiac disease in similar populations should not be done. EGD remains clinically important.

Does enteral nutrition affect clinical outcome? A systematic review of the randomized trials.

BACKGROUND: Both parenteral nutrition (PN) and enteral nutrition (EN) are widely advocated as adjunctive care in patients with various diseases. A systematic review of 82 randomized controlled trials (RCTs) of PN published in 2001 found little, if any, effect on mortality, morbidity, or duration of hospital stay; in some situations, PN increased infectious complication rates. OBJECTIVE: The objective was to assess the effect of EN or volitional nutrition support (VNS) in individual disease states from available RCTs. DESIGN: We conducted a systematic review. RCTs comparing EN or VNS with untreated controls, or comparing EN with PN, were identified and separated according to the underlying disease state. Meta-analysis was performed when at least three RCTs provided data. The evidence from the RCTs was summarized into one of five grades. A or B, respectively, indicated the presence of strong or weak (low-quality RCTs) evidence supporting the use of the intervention. C indicated a lack of adequate evidence to make any decision about efficacy. D indicated that limited data could not support the intervention. E indicated either that strong data found no effect, or that either strong or weak data suggested that the intervention caused harm. PATIENTS AND SETTINGS: RCTs could include either hospitalized or nonhospitalized patients. The EN or VNS had to be provided as part of a treatment plan for an underlying disease process. INTERVENTIONS: The RCT had to compare recipients of either EN or VNS with controls not receiving any type of artificial nutrition or had to compare recipients of EN with recipients of PN. OUTCOME MEASURES: These were mortality, morbidity (disease specific), duration of hospitalization, cost, or interventional complications. SUMMARY OF GRADING: A: No indication was identified. B: EN or VNS in the perioperative patient or in patients with chronic liver disease; EN in critically ill patients or low birth weight infants (trophic feeding); VNS in malnourished geriatric patients. (The low-quality trials found a significant difference in survival favoring the VNS recipients in the malnourished geriatric patient trials; two high-quality trials found nonsignificant differences that favored VNS as well.) C: EN or VNS in liver transplantation, cystic fibrosis, renal failure, pediatric conditions other than low birth weight infants, well-nourished geriatric patients, nonstroke neurologic conditions, AIDS; EN in acute pancreatitis, chronic obstructive pulmonary disease, nonmalnourished geriatric patients; VNS in inflammatory bowel disease, arthritis, cardiac disease, pregnancy, allergic patients, preoperative bowel preparation. D: EN or VNS in patients receiving nonsurgical cancer treatment or in patients with hip fractures; EN in patients with inflammatory bowel disease; VNS in patients with chronic obstructive pulmonary disease. E: EN in the first week in dysphagic, or VNS at any time in nondysphagic, stroke patients who are not malnourished; dysphagia persisting for weeks will presumably ultimately require EN. CONCLUSIONS: There is strong evidence for not using EN in the first week in dysphagic, and not using VNS at all in nondysphagic, stroke patients who are not malnourished. There is reasonable evidence for using VNS in malnourished geriatric patients. The recommendations to consider EN/VNS in perioperative/liver/critically ill/low birth weight patients are limited by the low quality of the RCTs. No evidence could be identified to justify the use of EN/VNS in other disease states.

Herbal supplements.

Herbal dietary supplements are taken by many individuals, often without the knowledge of their clinicians. Herbals have many pharmacologic and medicinal properties but are unregulated with respect to manufacturing purity, safety, and efficacy. Although clinicians often dismiss the utility of herbal therapy, many randomized controlled trials of herbal use in gastrointestinal and liver diseases have been conducted. There is no evidence for benefit from herbal supplements in the treatment of liver disease, but sufficient evidence exists for their use in functional gastrointestinal symptoms to warrant further investigation.

Vitamin supplementation: what the gastroenterologist needs to know.

BACKGROUND: The vitamin business is a multimillion dollar industry. Aggressive marketing strategies are used to make claims for the health benefits of these products. Observational studies suggest that people who consume vitamin supplements decrease their risks for cancer, cardiovascular disease, and gastrointestinal disease. What is the evidence for these claims, and as a prescribing gastroenterologist, is there a scientific basis for vitamin supplementation? METHODS: A narrative review focusing on randomized controlled trials, where available, plus observational studies obtained from personal files, "on-line" searches, and references in reviewed articles. RESULTS: From the perspective of a gastroenterologist, there is strong evidence to recommend B12 supplementation in gastric and intestinal disease, as well as pernicious anemia. There exists moderate evidence to support B12 supplements in pancreatic disease. Vitamin D and calcium supplementation are recommended for persons with disorders of malabsorption, cholestasis, and illnesses requiring chronic steroids. Only observational studies suggest a correlation between vitamin D/calcium and decreased colorectal adenoma recurrence. Although folic acid supplementation is beneficial in persons on medications such as methotrexate and sulfasalazine, studies are contradictory with regard to folic acid and colon cancer prevention. Overall, antioxidants have not been proven to decrease the risk for colorectal adenoma, gastric cancer, or esophageal cancer. CONCLUSIONS: Observational studies do not correlate with randomized clinical trials; therefore, few definitive recommendations can be made. Vitamin supplements are appropriate for recognized deficiencies; however, there is a lack of evidence to support their effects in the prevention of chronic disease.

Ethics and gastrointestinal artificial feeding.

Medical ethics is the study of human values as they relate to the practice of medicine. Ethics intersects with gastroenterology primarily involving issues of gastric and intestinal artificial feeding at the end of life. Language imparts meaning. Gastric artificial feeding is not the same as eating. Recent data suggest that gastric artificial feeding does not prolong life in patients with dementia and dysphagia. Given the lack of documented benefit of gastrointestinal feeding in these patients, the literature has focused on selection of appropriate patients for this medical intervention. Ethical care involves compassion, communication, consultation, and collaboration in dealing with emotionally difficult circumstances.

Percutaneous endoscopic gastrostomy does not prolong survival in patients with dementia.

BACKGROUND: Artificial feeding by a percutaneous endoscopic gastrostomy (PEG) tube in patients with dementia has increased since the introduction of the endoscopic method of tube placement. Few studies have documented survival benefit from this intervention. This report reviews our experience with PEG tube placement for feeding patients with dementia. METHODS: All consultations for PEG tube placement were evaluated by a certified nutrition support nurse (L.M.M.) in consultation with a member of the gastroenterology physician staff (T.O.L.) for 24 months. Evaluation included the attainment of a brief medical history, a physical examination, and a review of comorbid conditions, laboratory variables for nutrition status, and bleeding risk. Interviews with patients or surrogates were conducted, including an explanation of the risks and benefits of PEG tube placement. A Kaplan-Meier survival curve was used to compare the median survival between patients with dementia who received a PEG tube and patients with dementia in whom PEG tube placement was refused. RESULTS: We received 41 consultations for PEG tube placement in patients with dementia. Percutaneous endoscopic gastrostomy was performed in 23 patients; 18 patients met the medical criteria for PEG tube placement, but surrogates refused placement. The median survival for the 23 patients who underwent PEG was 59 days; the median survival for the 18 patients who did not undergo PEG was 60 days. CONCLUSION: There seems to be no survival benefit in patients with dementia who receive artificial feeding by a PEG tube.

Endoscopic Nd:YAG laser with aggressive multimodality therapy for locally advanced esophageal cancer.

BACKGROUND: Laser therapy of esophageal carcinoma has been limited to management of malignant dysphagia. To investigate its cytoreductive potential, Nd:YAG laser tumor debulking was added to multimodality therapy. METHODS: From 1994-1998, 29 patients with advanced locoregional esophageal carcinoma were enrolled in a prospective experimental study of high-dose neoadjuvant chemoradiotherapy together with endoscopic Nd:YAG laser photoablation. Comparisons were made to a retrospective cohort of 31 patients treated from 1990 to 1994 who underwent similar neoadjuvant chemoradiotherapy without laser debulking. RESULTS: Laser dosage ranged from 3457 to 67,443 J (mean 21,832 [SD 16,999]) delivered in 1 to 6 (mean 2.6 [1.4]) treatment sessions. Actuarial analysis showed improved survival in the laser-treated group versus the reference group (30.1 months vs. 16.5 months; p = 0.047). Multivariable analysis of the impact of age, T-stage, N-stage, completion of neoadjuvant therapy, and laser debulking that included all patients in both treatment groups showed completion of therapy to be the most significant variable associated with survival. There were 3 complications related to laser therapy. Relief of dysphagia was achieved in 19 of 29 patients (66%) in the laser group versus 13 of 31 (42%) in the reference group. CONCLUSIONS: Malignant dysphagia may be more effectively treated by the addition of Nd:YAG laser therapy to aggressive multimodality therapy. Improved survival with the addition of laser debulking warrants longer follow-up and a prospective comparative trial.