Prophylactic 5-Fr pancreatic duct stents are superior to 3-Fr stents: a randomized controlled trial.

BACKGROUND: Temporary prophylactic pancreatic duct stenting effectively reduces post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients, but the optimal stent remains unclear. We compared rate of spontaneous passage, and technical difficulty of placement for 3-Fr and 5-Fr stents. METHODS: A randomized controlled trial at a single academic medical center. Patients deemed high risk for PEP randomly received 5-Fr or 3-Fr pancreatic duct stents. Primary outcome was spontaneous stent passage by 2 weeks. Secondary outcomes were ease and time for stent placement, and number of guide wires required for the entire procedure. RESULTS: Patients (69 female [89 %]; mean age 44.9 years, standard deviation [SD] 16.8) were randomly assigned to receive 5-Fr (n = 38) and 3-Fr (n = 40) stents. Indications for stenting were similar. Seven patients in the 3-Fr group actually received a 5-Fr stent, and two in the 5-Fr group had a 3-Fr stent. Spontaneous passage or non-passage was confirmed in 64 (83 %). No statistically significant difference in spontaneous passage rates was seen (5-Fr group, 68.4 %; 3-Fr group 75.0 %; P = 0.617). Non-passage rates were 10.5 % (5-Fr group) and 10.0 % (3-Fr group) ( P = 1.00). The study was stopped after a futility analysis for the primary end point. Placement of 5-Fr stents was rated easier, at a mean score of 1.8 (5-Fr) vs. 3.4 (3-Fr), P < 0.001, with a trend towards being faster, 9.2 vs. 11.1 minutes ( P = 0.355). Fewer guide wires were required for 5-Fr stent placement, 1.5 vs. 1.9 ( P = 0.002). PEP rates did not differ ( P = 0.519). CONCLUSION: Placement of 5-Fr compared to 3-Fr pancreatic duct stents for PEP prophylaxis is easier, faster, and requires fewer wires. No statistically significant difference in spontaneous passage was found between the two sizes.

Efficacy of antidepressants and psychological therapies in irritable bowel syndrome: systematic review and meta-analysis.

OBJECTIVE: Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Evidence for treatment of the condition with antidepressants and psychological therapies is conflicting. DESIGN: Systematic review and meta-analysis of randomised controlled trials (RCTs). MEDLINE, EMBASE and the Cochrane Controlled Trials Register were searched (up to May 2008). SETTING: RCTs based in primary, secondary and tertiary care. PATIENTS: Adults with IBS. INTERVENTIONS: Antidepressants versus placebo, and psychological therapies versus control therapy or "usual management". MAIN OUTCOME MEASURES: Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). The number needed to treat (NNT) was calculated from the reciprocal of the risk difference. RESULTS: The search strategy identified 571 citations. Thirty-two RCTs were eligible for inclusion: 19 compared psychological therapies with control therapy or "usual management", 12 compared antidepressants with placebo, and one compared both psychological therapy and antidepressants with placebo. Study quality was generally good for antidepressant but poor for psychological therapy trials. The RR of IBS symptoms persisting with antidepressants versus placebo was 0.66 (95% CI, 0.57 to 0.78), with similar treatment effects for both tricyclic antidepressants and selective serotonin reuptake inhibitors. The RR of symptoms persisting with psychological therapies was 0.67 (95% CI, 0.57 to 0.79). The NNT was 4 for both interventions. CONCLUSIONS: Antidepressants are effective in the treatment of IBS. There is less high-quality evidence for routine use of psychological therapies in IBS, but available data suggest these may be of comparable efficacy.

Management of cardiopulmonary and trauma resuscitation in the pediatric emergency department.

The etiology and management of critical illness and injury in a pediatric emergency department were reviewed to survey the use of cardiopulmonary and trauma resuscitation and to compare these data with the educational content of Pediatric Advanced Life Support (PALS) courses. The emergency department records of 183 patients treated in the cardiopulmonary/trauma resuscitation room of a pediatric emergency department over a 17-month period were reviewed for data on diagnosis, morbidity, presence of apnea or pulselessness, and utilization of several resuscitation skills: intubation, cardioversion, tibial interosseous line placement, and other resuscitation techniques. Apneic and pulseless pediatric patients had poor survival (10.3%), but apneic patients had excellent survival (96.9%). Endotracheal intubation (57.9%), bag-valve-mask ventilation (63.9%), and medications for rapid-sequence induction of anesthesia prior to endotracheal intubation (25.7%) were used frequently. Inasmuch as asystole was the most common rhythm in pulseless patients, cardioversion and defibrillation were rarely used (2.2%). Specialized vascular access techniques, tibial interosseous lines (24.0%), and femoral intravenous lines (19.7%), were used frequently in pediatric patients. The frequent use of airway management skills and the excellent survival of apneic pediatric patients supports the current emphasis on airway management in PALS courses. Cardioversion/defibrillation should receive less emphasis in PALS courses. The frequent use of rapid-sequence induction of anesthesia prior to endotracheal intubation indicates that these techniques might warrant increased emphasis in the training of pediatric emergency department personnel and in PALS courses.

An evidence-based approach to the treatment of esophageal variceal bleeding.

Esophageal varices are a life threatening cause of gastrointestinal bleeding. Management includes both primary prevention of variceal bleeding and treatment of actively bleeding varices. Evidence from randomized controlled trials indicates that beta blockers and nitrates may prevent the initial episode of bleeding varices. Ample data from randomized controlled trials indicate that band ligation is more effective than scleropathy for the treatment of bleeding esophageal varices. Somatostatin may decrease rebleeding rates with or without endoscopic therapy. No effective treatment has been developed for the treatment of patients who fail endoscopic therapy.

Calibrated approach to endoscopic sinus surgery.

Endoscopic sinus surgery, in which the surgeon views the nose and paranasal sinuses through a telescope, can potentially lead to loss of perspective of the patient's entire head. Preoperative computed tomographs are also taken at angles different from those encountered in the surgical setting. As a result, the appropriate angle and depth of instrument insertion can fail to be appreciated. In order to study those angles and depths in a setting that more closely resembles the clinical situation in the operating room, we have performed 15 cadaver dissections and measured 14 dimensions relevant to the endoscopic approach. We recommend that cadaver dissection be an important part of continued training in sinus surgery. We also recommend that a reference probe be place along the floor of the nose and that endoscopic instruments be calibrated at 1-cm intervals so that the depth of insertion can be monitored by an observer or instructor.

Intussusception in an HIV-infected patient: a case report and review of the literature.

Intussusception, the telescoping of one segment of bowel onto an adjacent segment, is uncommon in adults in the United States. This is in contrast to intussusception in the tropics, where most cases occur in adults with GI infections. HIV-infected patients are at high risk for conditions that predispose to intussusception, namely tumors and infections of the GI system. We describe a case of intussusception in an adult patient with AIDS and review the pertinent clinical and diagnostic features of this condition.

Systematic review: efficacy and safety of pancreatic enzyme supplements for exocrine pancreatic insufficiency.

BACKGROUND: Pancreatic enzyme supplements are standard therapy for fat malabsorption in patients with exocrine pancreatic insufficiency. The FDA determined that published data are insufficient to support the efficacy and safety of these agents. AIM: To determine if pancreatic enzyme supplements are: (i) superior to placebo for treating fat malabsorption and (ii) superior to other supplements based on randomized cross-over trials. METHODS: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Data extraction on study design, improvement in coefficient of fat absorption, diarrhoea and adverse events using prespecified forms. RESULTS: A total of 12 manuscripts met inclusion criteria. Most studies (10/12) compared pancreatic enzyme supplements that used different delivery systems, while using similar quantities of enzymes. These studies found no consistent difference in fat malabsorption or gastrointestinal symptoms between different active treatments. Two small placebo-controlled trials (n = 65 patients) demonstrate that pancreatic enzyme supplements are superior to placebo for fat absorption. Data are inadequate to determine if pancreatic enzyme supplements lead to weight gain or improvement in diarrhoea. CONCLUSIONS: Based on data from randomized cross-over trials, pancreatic enzyme supplements appear to improve fat malabsorption. No specific branded product or specific delivery system is superior for treatment of fat malabsorption in patients with exocrine pancreatic insufficiency.

Meta-analysis: re-treatment of genotype I hepatitis C nonresponders and relapsers after failing interferon and ribavirin combination therapy.

BACKGROUND: The efficacy of re-treating genotype I hepatitis C virus (HCV) patients who failed combination therapy with interferon/pegylated interferon (PEG-IFN) and ribavirin remains unclear. AIMS: To quantify sustained virological response (SVR) rates with different re-treatment regimens through meta-analysis of randomized controlled trials (RCTs). METHODS: Randomized controlled trials of genotype I HCV treatment failure patients that compared currently available re-treatment regimens were selected. Two investigators independently extracted data on patient population, methods and results. The pooled relative risk of SVR for treatment regimens was computed using a random effects model. RESULTS: Eighteen RCTs were included. In nonresponders to standard interferon/ribavirin, re-treatment with high-dose PEG-IFN combination therapy improved SVR compared with standard PEG-IFN combination therapy (RR=1.49; 95% CI: 1.09-2.04), but SVR rates did not exceed 18% in most studies. In relapsers to standard interferon/ribavirin, re-treatment with high-dose PEG-IFN or prolonged CIFN improved SVR (RR=1.57; 95% CI: 1.16-2.14) and achieved SVR rates of 43-69%. CONCLUSIONS: In genotype I HCV treatment failure patients who received combination therapy, re-treatment with high-dose PEG-IFN combination therapy is superior to re-treatment with standard combination therapy, although SVR rates are variable for nonresponders (≤18%) and relapsers (43-69%). Re-treatment may be appropriate for select patients, especially relapsers and individuals with bridging fibrosis or compensated cirrhosis.

Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis.

BACKGROUND: Pancreatic enzyme supplementation is standard treatment for malabsorption caused by chronic pancreatitis. The FDA recently required all manufacturers to submit New Drug Applications to continue to market these agents because published data demonstrated variation in formulation, bioavailability and shelf-life while providing limited data about efficacy and safety. AIM: To review systematically the design and results of randomized, parallel-design trials of pancreatic enzyme supplements in chronic pancreatitis patients with steatorrhea. METHODS: A computer-assisted search of MEDLINE and EMBASE was performed to identify relevant studies. Two authors performed duplicate data extraction on study design, improvement in coefficient of fat absorption (CFA), diarrhoea and adverse events using pre-specified forms. Agreement between investigators for data extraction was greater than 95%. RESULTS: Of 619 articles found through literature searching, 20 potentially relevant articles were identified and four manuscripts met inclusion criteria. No studies performed head-to-head comparisons of different supplements. Enzyme supplementation is more likely to improve CFA compared with placebo, but fat malabsorption remained abnormal. Important differences in patient population, study endpoint, study design, pancreatic enzyme dosage and measurement of CFA were present across trials, which precluded comparison of different agents. CONCLUSIONS: Enzyme supplementation improves CFA compared to placebo, but may not abolish steatorrhoea.

Acid peptic diseases in the era of Helicobacter pylori.

The treatment of peptic ulcers has been revolutionized by the discovery that Helicobacter pylori (H. pylori) bacteria is a causative agent for ulcer formation. However, when patients present with dyspepsia or epigastric discomfort, more than 80% of patients will not have ulcer disease and empiric treatment of H. pylori is not recommended for these patients. Eradication of H. pylori has not been demonstrated to improve the symptoms of non-ulcer dyspepsia compared with non-ulcer dyspepsia patients treated with placebo. Therefore, we recommend that patients should first be evaluated for peptic ulcers with endoscopy or upper gastrointestinal series before the diagnosis and treatment of H. pylori. Generally, the treatment of H. pylori should be limited to patients with peptic ulcers, mucosal-associated lymphoid tissue lymphomas, and gastric cancers. Most diagnostic tests for H. pylori, including quantitative IgG antibody, urea breath tests, rapid urease tests (CLO), tests of gastric mucosal biopsies, and staining of gastric mucosal biopsies, have equivalent diagnostic characteristics. Therefore, the choice of diagnostic test for H. pylori should be based on cost, ease of use, and lack of complications. Multiple antibiotic regimens are available for the treatment of H. pylori. Triple antibiotic therapy is the least expensive but has the highest rate of side effects and the least compliance. Combining a proton pump inhibitor with clarithromycin and another antibiotic will eradicate H. pylori with fewer side effects and better compliance but this is the most expensive antibiotic regimen.

Documentation in the pediatric emergency department: a review of resuscitation cases.

STUDY OBJECTIVE: Documentation practices of staff physicians, residents, and nurses managing critically ill children were reviewed for completion of standard documentation requirements. DESIGN: Retrospective chart review. SETTING: Municipal children's hospital. PARTICIPANTS: 144 patients treated in the cardiopulmonary/trauma resuscitation room over a 17-month period. INTERVENTION: Emergency department records of these patients were reviewed for medical information required by Joint Commission on Accreditation of Healthcare Organizations guidelines: history of present illness, medical history, vital signs, physical examination, laboratory results, clinical observations, and diagnostic impression. In addition, the frequency of medical record review by legal representatives of the patient and by the state's social service agencies was evaluated. RESULTS: Attending physicians demonstrated more complete documentation than residents in clinical observations of patients (36.4% vs 18.0%, P less than .005) and diagnostic impression (97% vs. 78.4%, P less than .03). Nurses demonstrated more complete documentation than physicians, as a group, in laboratory results (83.9% vs 47.6%, P less than .001) and clinical observations (80.6% vs 22.2%, P less than .001). Sixty-six medical records (37.9%) were subjected to legal review: 37 (21.3%) by patients' legal representatives, and 29 (16.7%) by the state's social service agency. CONCLUSION: ED record documentation of pediatric patients treated in a cardiopulmonary/trauma resuscitation room often does not meet standard guidelines. Complete documentation is important due to the frequency of legal review of these records and the need to ensure post-ED continuity of care.

Conducted current on guidewires in single lumen papillotomes.

An in vitro electrical circuit was designed to measure conducted current in plastic-coated guidewires and standard guidewires inserted in a single lumen papillotome. Single lumen papillotomes, which are more flexible than double lumen papillotomes, require the removal of the guidewire before electrosurgery due to concern over conducted current. In an in vitro electrical circuit, equivalent current was measured in both the papillotome wire and the standard guidewire. Plastic-coated guidewires did not allow any current flow. The advantages of flexible single lumen papillotomes and maintenance of deep biliary cannulation over a guidewire may be combined if insulated plastic-coated guidewires are used.

Licensure, use, and training of paramedical personnel to perform screening flexible sigmoidoscopy.

BACKGROUND: The purpose of this study was to assess the state board of nursing guidelines about the performance of flexible sigmoidoscopy by nurses and to determine the current use and training of paramedical personnel in flexible sigmoidoscopy at gastroenterology fellowship programs in the United States. METHODS: Separate one-page questionnaires were sent to state boards of nursing and directors of endoscopy at gastroenterology fellowship programs in the United States. RESULTS: Twenty percent (10 of 50) of state boards of nursing explicitly approve the performance of sigmoidoscopy by registered nurses, and 50% (25 of 50) explicitly approve the practice by nurse practitioners. Forty-six percent (23 of 50) of state boards of nursing have no written policy but allow nurses to use a "decision making model" to determine whether the performance of sigmoidoscopy is allowed. Fifteen percent (24 of 164) of gastroenterology fellowship programs in the United States use paramedical personnel to perform flexible sigmoidoscopy. Sixty-three percent (15 of 24) of these programs started since 1995, and 67% (16 of 24) require that the paramedical personnel perform 50 or more supervised sigmoidoscopies during their training. Forty-five percent (5 of 11) of programs with physician assistants/nurse practitioners use these personnel to perform colonoscopy or endoscopy. CONCLUSIONS: Nurses are allowed to perform flexible sigmoidoscopy in most states based on current state board of nursing guidelines. The use of paramedical personnel to perform endoscopic procedures is increasing rapidly.

Suppression of cell-mediated immunity in hypothyroidism.

A 71-year-old man had severe hypothyroidism, chronic autoimmune thyroiditis, and bacteremia due to Edwardsiella tarda. Review of the literature identified the hypothesis that E tarda infections may occur more frequently in immunocompromised patients. Previous animal studies have shown decreases in lymphocyte function during hypothyroidism, with return of normal lymphocyte function during euthyroid states. Therefore, lymphocyte transformation studies were obtained, demonstrating severe decreases in our patient's lymphocyte function. Except for chronic autoimmune thyroiditis, other immune system abnormalities were excluded. Serial lymphocyte transformation studies showed gradual improvement in lymphocyte function during gradual return to euthyroid state. Possible pathophysiologic mechanisms for these findings will be reviewed.

Effectiveness and patient satisfaction with screening flexible sigmoidoscopy performed by registered nurses.

BACKGROUND: Our aim was to compare the effectiveness and patient satisfaction with flexible sigmoidoscopy performed by a registered nurse, general surgeons, and gastroenterology fellows. METHODS: Consecutive outpatients referred for sigmoidoscopy were assigned to have the procedure performed by the first available provider. Depth of insertion of the sigmoidoscope, complications, duration of the procedure, and percentage of patients with adenomas were recorded. After the procedure, patients completed a validated patient satisfaction questionnaire. RESULTS: Mean depth of insertion was less for general surgeons compared with the nurse and gastroenterology fellows (50 vs 53 vs 54 cm, respectively; p = 0.01). Mean duration of procedure was longer for the nurse compared with general surgeons and gastroenterology fellows (8.3 vs 7.6 vs 6.8 min, respectively; p = 0.0001). Percentage of patients with adenomas was similar among patients who underwent sigmoidoscopy by the endoscopists (7% vs 8% vs 9%; p = 0.81). No differences were detected between endoscopists for overall satisfaction (p = 0.60), technical skills of the endoscopist (p = 0.58), communication skills of the endoscopist (p = 0.61), or interpersonal skills of the endoscopist (p = 0.59). CONCLUSION: No clinically significant differences in effectiveness or patient satisfaction were detected with flexible sigmoidoscopy performed by a registered nurse, general surgeons, or gastroenterology fellows.

The effect of acidified enteral feeds on gastric colonization in critically ill patients: results of a multicenter randomized trial. Canadian Critical Care Trials Group.

OBJECTIVE: To evaluate the effect of acidified enteral feeds on gastric colonization in critically ill patients compared with a standard feeding formula. DESIGN: Randomized, double-blind, multicenter trial. SETTING: Eight mixed intensive care units at tertiary care hospitals. PATIENTS: We recruited mechanically ventilated critically ill patients expected to remain ventilated for >48 hrs. We excluded patients with gastrointestinal bleeding, acidemia, and renal failure requiring dialysis. We enrolled 120 patients; 38% were female, age (mean +/- SD) was 57.6+/-19.3 yrs, and Acute Physiology and Chronic Health Evaluation II score (mean +/- SD) was 21.6+/-7.6. INTERVENTIONS: Vital High Nitrogen (Abbott Laboratories, Ross Products Division, Columbus, OH) was used as the standard feeding formula for the control group (pH = 6.5). Hydrochloric acid was added to Vital High Nitrogen to achieve a pH of 3.5 in the experimental group. MEASUREMENTS AND MAIN RESULTS: The main outcome measure was gastric colonization. Secondary outcomes included gastric pH, pneumonia, and mortality. The mean gastric pH in patients receiving acid feeds was lower (pH = 3.3) compared with controls (pH = 4.6; p<.05). One patient (2%) on acid feeds was colonized in the stomach with pathogenic bacteria, compared with 20 patients (43%) in the control group (p<.001). There was no difference in the incidence of pneumonia (6.1% in the acid feeds group vs. 15% in the control group; p = .19). Overall, there were 15 deaths in the acid feeds group and seven in the control group (p = .10); four patients in the acid feeds group and three in the control group died during the study period (p not significant). CONCLUSIONS: Acidified enteral feeds preserve gastric acidity and substantially reduce gastric colonization in critically ill patients. Larger studies are needed to examine its effect on ventilator-associated pneumonia and mortality.