Janek Binek

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.

Cytomegalovirus-Induced Transient Protein-Losing Hypertrophic Gastropathy in an Immunocompetent Adult

Transient protein-losing hypertrophic gastropathy with similarity to Ménétrier’s disease is described. Acute infection with cytomegalovirus (CMV) could be shown to play a causative role. Immunodeficiency was ruled out. The 34-year-old patient had complete resolution of the disease without antiviral treatment. To our knowledge the present report is the first case of CMV-associated protein-losing hypertrophic gastropathy in an immunocompetent adult. To date, a similar disorder has only been described in children. CMV infection should be considered in patients with acute and symptomatic protein loss of gastrointestinal origin.

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.

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 Crohns 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 CZPs effectiveness in perianal fistulizing CD in clinical practice. (Inflamm Bowel Dis 2011;)

Diffuse abdominal pain, nausea and vomiting due to retroperitoneal fibrosis : a rare but often missed diagnosis

Retroperitoneal fibrosis is a rare chronic inflammatory disease usually involving the ureters, retroperitoneal vessels and nerves; however, any intestinal organ may also be involved. In recent years, a few successful immunosuppressive treatments of this disease have been described and surgery can, therefore, probably be avoided in most cases. We report here on a case of secondary retroperitoneal fibrosis with compression and midline deviation of the ureters and impaired renal function which was probably caused by ergotamine abuse because of migraine. The patient complained of diffuse abdominal pain, nausea and vomiting. After immunosuppressive treatment with azathioprine and prednisone for a year, we observed a complete resolution of the retroperitoneal mass on computed tomography, although renal function remained impaired. Eleven months after the cessation of treatment, the patient had not relapsed.

Ultrasound-guided fine-needle aspiration of abdominal masses: Accuracy and short-term complications

Abstract Objective: To assess prospectively the sensitivity, specificity and short-term complications (24 h) of fine-needle ultrasound-guided punctures (FNA) of abdominal tumors. Methods: Fine-needle punctures were taken in 102 patients (188 needle passes) and after preparation the aspirate was examined by two experienced pathologists. Results: the sensitivity in detecting malignancy was 91.7% and the specificity 100%. The negative predictive value was 78.5%, the positive predictive value 100% and the overall accuracy 93.6%. We did not find an association between true positive or true negative results and the macroscopic appearance of the smear or the size of the punctured lesion. The minor complications rate was 3.9% (2.1% per needle pass), with no major complications. Conclusion: FNA of abdominal masses is a safe diagnostic procedure, with high specificity and sensitivity in detecting malignancies.

Malignant biliary stenosis: conventional cytology versus DNA image cytometry

BackgroundThe 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.MethodsA 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.ResultsDiagnosis 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).ConclusionsICM-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.

Systematic Assessment of Items Influencing Crohn's Disease Patient's Preferences in Selecting an Anti-TNF Agent (Choose TNF Trial)

Background and Aims: The three anti-TNF agents infliximab (IFX), adalimumab (ADA) and certolizumab pegol (CZP) have demonstrated similar efficacy in induction and maintenance of response and remission in Crohns disease (CD) treatment. Given the comparability of these drugs, patients preferences may influence the choice of the product. However, data on patients preferences for choosing anti-TNF agents are lacking. We therefore aimed to assess the CD patients appraisal to select the drug of his choice and to identify factors guiding this decision. Methods: A prospective survey among anti-TNF-naive CD patients was performed. Patients were provided a description of the three anti-TNF agents focusing on indication, application mode (s.c. vs. i.v.), application time intervals, setting of application (hospital vs. private practice vs. patients home), average time to apply the medication per month, typical side effects, and the scientific evidence of efficacy and safety available for every drug. Patients answered a questionnaire consisting of 17 questions, covering demographic, disease-specific, and medication data. Results: Hundred patients (47f/53m, mean age 45±16 years) completed the questionnaire. Disease duration was 5 years in 62% of patients. Disease location was ileal in 33%, colonic in 40%, and ileocolonic in 27%. Disease phenotype was inflammatory in 68%, stenosing in 29%, and internally fistulizing in 3% of patients. Additionally, 20% had perianal fistulizing disease. Patients were already treated with the following drugs: mesalamines 61%, budesonide 44%, prednisone 97%, thiopurines 78%, methotrexate 16%. In total, 30% had already heard about IFX, 20% about ADA, and 11% about CZP. Thirty-six percent voted for treatment with ADA, 28% for CZP, and 25% for IFX, whereas 11% were undecided. The following factors influenced the patients decision for choosing a specific anti-TNF drug (several answers possible): side effects 76%, physicians recommendation 66%, application mode 54%, efficacy experience 52%, time to spend for therapy 27%, patients recommendations 21%, interactions with other medications 12%. The single most important factor for choosing a specific anti-TNF was (1 answer): side effect profile 35%, physicians recommendation 22%, efficacy experience 21%, application mode 13%, patients recommendations 5%, time spent for therapy 3%, interaction with other medications 1%. Conclusions: The majority of patients preferred anti-TNF syringes to infusions. The safety profile of the drugs and the physicians recommendation are major factors influencing the patients choice for a specific anti-TNF drug. Patients issues about safety and lifestyle habits should be taken into account when prescribing specific anti-TNF formulations.

S1242 Through-the-Scope Dilation in Stenotic Crohn's Disease: Results of a Large Cohort of Consecutive Patients

BACKGROUND: Sub-occlusions are frequent complications of Crohns disease (CD). They are usually caused by stenosis, which can be due to recurrent CD or ischemic anastomosis. Through-the-scope balloon dilation (TTS) is the only alternative to intestinal resection or stricturoplasty for the treatment of intestinal strictures. Previous studies have reported a long-term symptomatic benefit of TTS balloon dilation in CD ranging from 48% and 66%. The aim of this study is to evaluate safety and efficacy of repeated TTS balloon dilations in CD strictures. PATIENTS AND METHODS: We retrospectively analyzed consecutive endoscopy protocols of all CD patients who underwent colonoscopy or rectosigmoidoscopy with TTS balloon dilation between 2000 and 2007, in the hospital databases of University Hospital of Lausanne and Kantonspital St Gallen, Switzerland. All patients had histologically proven CD that did not improve under medical CD treatment, including 5-amino salicylic acid, azathioprine, 6-mercaptopurine, methotrexate, budesonide, prednisone or anti-TNFα. Hydrostatic TTS balloon dilation was performed using Wilson Cook/Boston Scientific balloons progressively inflated to maximal pressure for 60 seconds. RESULTS: Sixty-one consecutive patients (33 females, 28 males), mean age 37±11 years, underwent dilation for a total of 237 dilations. Mean balloon diameter was 18mm (range 10-25mm). An inflammatory activity was observed in 75% of strictures, 129 dilations were performed on anastomotic strictures (54%), the other dilations were performed on surgically naive bowel (21 in terminal ileum, 11 at the ileo-cecal valve,4 in the right colon, 21 in the left colon, 51 in the rectoanal region). Mean number of dilations was 2.25 (interval range 1 to 21) per stricture. All patients had symptoms relief post dilation, mean time before repeated dilation was 132 days (range: 3-1495 days). One perforation occured, which required surgery. CONCLUSION: TTS balloon dilation is a safe and effective treatment of CD strictures. It can be used to treat anastomotic as well as disease-induced stenosis, independently of inflammatory status. Multiple TTS balloon dilations of the same stenosis is often required to improve symptoms. Repeated TTS dilations did not increase the risk of complications.

7170 Miniprobe-eus in gastrointestinal endoscopy: technical feasibility, results, and clinical impact.

Aim: Miniprobe-EUS (MP-EUS) is a potentially time and cost saving endosonographic technique. Our prospective study was aimed at technical feasibility, diagnostic results and herewith the clinical impact. Methods: Three EUS-experienced endoscopists performed MP-EUS during upper and lower endoscopy in selected patients with expected diagnostic benefit from EUS. Five different either 12 or 20MHz Miniprobes (Olympus UM- 2R/-3R/-G20-29R/-S20-20R) were inserted through the working channel of regular endoscopes. In case of incomplete visualization other standard diagnostic procedures were performed. We also focused on practical aspects, such as examination time or technical difficulties. The impact on further examinations was judged on clinical basis. Results: In 42 patients (21 female, median age 67 [32-90]) we performed 51 MP-EUS examinations (Table 1). The average time of examination for the MP-EUS was 12,2 minutes [5-25]. Incorrect operation of MP was seen four times. In 16 patients MP-EUS was performed as intraductal ultrasound (IDUS) in coexamination with ERCP. 80% of the remaining examinations (25/31), were considered to be sufficient as sole diagnostic imaging procedure. MP-EUS had a direct clinical impact on therapeutical decisions in 38/47 (80%) of our examinations. Conclusions: In selected patients and in the hands of EUSexperienced endoscopists, Miniprobe-EUS is a valuable diagnostic technique and has a positive impact on clinical decision making in both benign and malignant superficial lesions of the gastrointestinal tract.