Outcomes of percutaneous endoscopic gastrostomy tube insertion in respiratory impaired amyotrophic lateral sclerosis patients under noninvasive ventilation.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) tube placement in amyotrophic lateral sclerosis (ALS) patients with impaired respiratory function is associated with an increased risk of peri-procedural and post-interventional complications. It was the aim of the study to analyze peri- and post-interventional complications and survival after PEG tube placement under noninvasive ventilation (NIV) in ALS patients with various degrees of respiratory impairment. METHODS: Twenty-six subjects were included in this retrospective case study. Prior to PEG tube placement, training with ventilatory support via an oronasal mask was performed with ALS subjects on the pneumology ward. PEG placement was then performed under continuous NIV. FVC, sniff nasal inspiratory pressure, and demographic data were assessed. Complication rates and 1-month and overall survival rates were analyzed. RESULTS: There were no deaths within 24 hours after PEG placement. One subject died within the first month. The mean survival rate after PEG was 12 ± 10 months (range 0.6-42 months). There was no difference in post-PEG survival between subjects with moderately (> 50%) and severely (< 50%) impaired FVC. CONCLUSIONS: In this case series, PEG tube insertion was associated with minimal peri- and post-procedural complications. The low complication rate might be due to the systematic use of procedural NIV in ALS subjects.

Systematic assessment of factors influencing preferences of Crohn's disease patients in selecting an anti-tumor necrosis factor agent (CHOOSE TNF TRIAL).

BACKGROUND: Infliximab (IFX), adalimumab (ADA), and certolizumab pegol (CZP) have similar efficacy in induction and maintenance of clinical remission in Crohn's disease (CD). Given the comparable nature of these drugs, patient preferences may influence the choice of the product. We aimed to identify factors that may contribute to CD patients' decision in selecting one anti-tumor necrosis factor (TNF) agent over the others. METHODS: A prospective survey was performed among anti-TNF-naïve CD patients. Prior to completion of a questionnaire, patients were provided with a written description of the three anti-TNF agents, focusing on indications, mode of administration, side effects, and scientific evidence of efficacy and safety for each drug. RESULTS: One hundred patients (47 females, mean age 45 ± 16 years, range 19-81) with an ileal, colonic, or ileocolonic (33%, 40%, and 27%, respectively) disease location completed the questionnaire. Based on the information provided, 36% of patients preferred ADA, 28% CZP, and 25% IFX, whereas 11% were undecided. The patients' decision in selecting a specific anti-TNF drug was influenced by the following factors: ease of use (69%), time required for therapy (34%), time interval between application of the drug (31%), scientific evidence for efficacy (19%), and fear of syringes (10%). CONCLUSIONS: The majority of patients preferred anti-TNF medications that were administered by subcutaneous injection rather than by intravenous infusion. Ease of use and time required for therapy were two major factors influencing the patients' selection of a specific anti-TNF drug. Patients' individual preferences should be taken into account when prescribing anti-TNF drugs.

Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey.

BACKGROUND: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. METHODS: Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines. RESULTS: Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and 43% to adalimumab. A significant decrease of the Harvey-Bradshaw Index (HBI) was observed under CZP therapy (12.2 ± 4.9 at week 0 versus 6.3 ± 4.7 at week 6 and 6.7 ± 5.3 at week 26, both P < 0.001). Response and remission rates were 70% and 40% (week 6) and 67% and 36%, respectively (week 26). The complete perianal fistula closure rate was 36% at week 6 and 55% at week 26. The frequency of adverse drug reactions attributed to CZP was 5%. CZP was continued in 88% of patients beyond week 6 and in 67% beyond week 26. CONCLUSIONS: In a population of CD patients with predominantly complicated disease behavior, CZP proved to be effective in induction and maintenance of response and remission. This series provides the first evidence of CZP's effectiveness in perianal fistulizing CD in clinical practice.

Malignant biliary stenosis: conventional cytology versus DNA image cytometry.

BACKGROUND: The aim of this study is to evaluate the utility of image cytometry (ICM)-DNA analysis on cytological brush specimens in improving the sensitivity and diagnostic accuracy for biliary neoplasias. METHODS: A total of 71 patients with 89 samples of biliary tree brushing from a stenosis were included in this prospective study. Conventional cytology (CC) and DNA ploidy using ICM of the brushing were performed. Benign or malignant findings were confirmed by surgical exploration or a clinical follow-up of at least 12 months. RESULTS: Diagnosis was confirmed by clinical follow-up in 44 cases and surgical investigation or histology in 41 cases. A definitive diagnosis of the smears resulted in 40 malignant and 49 benign diagnoses. The sensitivity was 0.666 for CC and 0.658 for ICM, and the specificity was 0.920 and 0.937, respectively. The positive predictive value (PPV) was 0.866 for CC and 0.900 for ICM. McNemar's test did not reveal a significant difference between CC and ICM (P=0.803). Agreement of the two methods was found in 73 samples, raising specificity to 0.998 but not sensitivity (0.725). CONCLUSIONS: ICM-DNA seems not to improve significantly the PPV and NPV for detecting neoplasias of the biliary tract compared to CC. Nevertheless a clinical advantage can be seen in the agreement of the two methods in diagnosing dysplasia or cancer, since it did not show false positive results.

Evaluation of endoscopy in localizing transgastric access for natural orifice transluminal endoscopic surgery in humans.

BACKGROUND: To date, transgastric access in humans for natural orifice transluminal endoscopic surgery (NOTES) has been poorly evaluated. OBJECTIVE: To compare endoscopic visualization of the transgastric access point with the laparoscopically defined ideal entrance to the peritoneal cavity. DESIGN: Prospective pilot study in humans. SETTING: Single tertiary-care center. PATIENTS: This study involved 31 patients referred for laparoscopic cholecystectomy. INTERVENTION: Access points were marked by endoscopy alone, endoscopy combined with diaphanoscopy, and endoscopy after pneumoperitoneum. Points were correlated with a laparoscopically visualized, previously defined ideal access area. MAIN OUTCOME MEASUREMENTS: To choose the appropriate access point within the laparoscopically defined ideal access area to the peritoneal cavity away from major vessels and adjacent organs, by using endoscopy and to establish landmarks for the endoscopist, look for a learning curve, and identify potential problems. RESULTS: The percentage of access points within the laparoscopically defined ideal area was 35.5% with endoscopy alone, 13.8% using the diaphanoscopy method, and 45.2% after transcutaneous pneumoperitoneum. A safe access point (> or = 3 cm from major gastric vessels) could be achieved with the 3 techniques in 83.9%, 65.5%, and 87.1% of patients, respectively. A positive learning curve for endoscopic localization was identified before (P = .008) and after (P = .014) pneumoperitoneum. Virtual complications were greater in obese patients. LIMITATIONS: This was a small pilot study with hypothetical complications and problems, because actual transgastric access was not performed. The criteria for an ideal access area were very strict. CONCLUSION: Endoscopy, especially with the use of pneumoperitoneum, can reliably locate a safe transgastric entrance point. However, the endoscopically chosen site correlates poorly with the ideal laparoscopically determined site for transgastric access.

Endosonographic radial tumor thickness after neoadjuvant chemoradiation therapy to predict response and survival in patients with locally advanced esophageal cancer: a prospective multicenter phase ll study by the Swiss Group for Clinical Cancer Research (SAKK 75/02).

BACKGROUND: EUS response assessment in patients with locally advanced esophageal cancer undergoing neoadjuvant chemoradiation therapy (CRT) is limited by disintegration of the involved anatomic structures. OBJECTIVE: Predictive and prognostic values of a prospectively defined maximum tumor thickness (MTT). DESIGN: Prospective open-label phase ll study (SAKK 75/02). SETTING: Multicenter, nationwide. PATIENTS: Of 66 patients with primary CRT, 56 underwent en bloc esophagectomy. INTERVENTIONS: EUS-measured MTT before and 2-5 weeks after CRT (yMTT). MAIN OUTCOME MEASUREMENTS: Cutoffs: (1) absolute thickness (yMTT) after CRT < or = 6 mm; (2) relative reduction compared with baseline (ratio yMTT/MTT) < or = 50%. Correlation between EUS measurements and histopathologic tumor regression grade (TRG) and overall survival (OS). RESULTS: Sixteen of 56 patients were not included for EUS evaluation (10 severe stenosis, 5 MTT not measured, 1 intolerance to second EUS). Characteristics (n = 40) were as follow: median age, 60 years; squamous cell carcinoma, 42%; and adenocarcinoma (AC), 58%. Initial stage was: 10 T2N1, 3 T3N0, 26 T3N1, 1 T3Nx; 14 of 23 AC Siewert type 1. Wilcoxon rank sum test showed significant correlation of TRG1 with yMTT < or = 6 mm (P = .008) and yMTT/MTT < or = 50% (P = .003). The effect of yMTT on TRG1 was significant (P = .0193; odds ratio, 0.687 [95% CI, 0.502-0.941]). The predefined cutoff of < or = 6 mm for yMTT was predictive for TRG1 (P = .0037; Fisher exact test). After a median follow-up of 28.6 months, there was a clear trend for benefit in OS with yMTT < or = 6 mm and yMTT/MTT < or = 50%. LIMITATIONS: Small sample size. CONCLUSION: In a multicenter setting, MTT measured by EUS after CRT was highly predictive for response and showed a clear trend for predicting survival.

Efficacy and safety of certolizumab pegol induction therapy in an unselected Crohn's disease population: results of the FACTS survey.

BACKGROUND: Switzerland was the first country to approve certolizumab pegol (Cimzia, CZP) for the treatment of patients with moderate to severe Crohn's disease (CD) in September 2007. This phase IV study aimed to evaluate the efficacy and safety of CZP in a Swiss multicenter cohort of practice-based patients. METHODS: Baseline and Week 6 evaluation questionnaires were sent to all Swiss gastroenterologists in hospitals and private practices. Disease activity was assessed with the Harvey-Bradshaw Index (HBI) and adverse events were evaluated according to WHO guidelines. RESULTS: Fifty patients (31 women, 19 men) were included; 56% had complicated disease (stricture or fistula) and 52% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 78% to infliximab, and 50% to adalimumab. A significant decrease in HBI was observed at Week 6 (versus Week 0) following induction therapy with CZP 400 mg subcutaneously at Weeks 0, 2, and 4 (12.6 +/- 4.7 Week 0 versus 6.2 +/- 4.4 Week 6, P < 0.001). Response and remission rates at Week 6 were 54% and 40%, respectively. We identified 8/11 CD patients undergoing a 50% fistula response (P = 0.021). The frequency of adverse drug reactions attributed to CZP was 6%. CZP was continued in 80% of patients beyond Week 6. CONCLUSIONS: In a population of CD patients with complicated disease behavior, CZP induced a response and remission in 54% and 40% of patients, respectively. This series provides the first evidence of the effectiveness of CZP in perianal fistulizing CD.

Perception of gastrointestinal endoscopy by patients and examiners with and without background music.

BACKGROUND/AIMS: Several studies have reported improved patient comfort with music in the preoperative setting, however music has seldom been assessed during gastrointestinal endoscopy. We aimed to assess how background music may influence the perception of patients and examiners involved in endoscopic examinations. METHODS: 301 patients (128 females, 173 males; mean age 59 years) were included in the study (EGD and colonoscopy) in a prospective fashion. 90 EGD and 61 colonoscopies were performed with music (50.17%) and 102 EGD and 48 colonoscopies without music (49.83%). Patients, nurses and endoscopists completed a questionnaire. RESULTS: No significant differences in demographic data were found between the patients examined with or without music. Tolerance to the examination, pain sensation and perception of the endoscopy room ambiance were similar in both groups. The majority of patients (83.4%) expressed a preference for music during any future endoscopic examination and none perceived the music as disturbing. During the 151 examinations, music was considered unpleasant in 14 examinations by the physicians (9.3%) and in 11 examinations by the nurses (7.3%). CONCLUSIONS: Music has little influence on patients' experience of gastrointestinal endoscopy. Nevertheless, the majority of patients felt music to be helpful and expressed a preference for music during any future examination. This positive attitude to music of patients is in contrast with the assessment of some endoscopists and nurses.