Josee Parent

The Value of Botox-A in Acute Radiation Proctitis: Results From a Phase I/II Study Using a Three-Dimensional Scoring System

PURPOSE Acute radiation proctitis (ARP) is a common side effect of pelvic radiotherapy, and its management is challenging in daily practice. The present phase I/II study evaluates the safety and efficacy of the botulinum toxin A (BTX-A) in ARP treatment for rectal cancer patients undergoing neoadjuvant high-dose-rate endorectal brachytherapy (HDREBT). METHODS AND MATERIALS Fifteen patients, treated with neoadjuvant HDREBT, 26-Gy in 4 fractions, received the study treatment that consisted of a single injection of BTX-A into the rectal wall. The injection was performed post-HDREBT and prior to the development of ARP. The control group, 20 such patients, did not receive the BTX-A injection. Both groups had access to standard treatment with hydrocortisone rectal aerosol foam (Cortifoam) and anti-inflammatory and narcotic medication. The ARP was clinically evaluated by self-administered daily questionnaires using visual analog scores to document frequency and urgency of bowel movements, rectal burning/tenesmus, and pain symptoms before and after HDREBT. RESULTS At the time of this analysis, there was no observed systemic toxicity. Patient compliance with the self-administered questionnaire was 100% from week 1 to 4, 70% during week 5, and 40% during week 6. The maximum tolerated dose was established at the 100-U dose level, and noticeable mean differences were observed in bowel frequency (p = 0.016), urgency (p = 0.007), and pain (p = 0.078). CONCLUSIONS This study confirms the feasibility and efficacy of BTX-A intervention at 100-U dose level for study patients compared to control patients. A phase III study with this dose level is planned to validate these results.

Tu1074 Videocapsule Versus Enteroscopy in Patients With Obscure GI Bleeding: Results of a Randomized Controlled Trial

Background: Videocapsule endoscopy (VCE), when compared to enteroscopy (E), is associated with increased detection of mucosal lesions in obscure gastrointestinal bleeding (OGB). However, few randomized trials have compared these two modalities, and data on clinical relevance are lacking. The aim of this study was to compare VCE with E in terms of diagnostic yield and subsequent clinical outcome. Methods: We randomly allocated adult patients with occult bleeding (iron deficiency anemia >6 months needing blood transfusion or iron supplementation with repeated positive stool occult blood testing) or overt bleeding (≥1episode of melena/hematochezia within 7 days of presentation and a hemoglobin drop ≥15 g/dL) to VCE or E after a negative initial work-up (single or repeated gastroscopy and colonoscopy examinations with or without small bowel radiology). The main outcomes were recurrence and persistence of bleeding using standardized criteria defined a priori over 1year. Crossovers were permitted after the main outcome was reached. Results: 79 patients (68.5±14.5yrs, 36.7% female) were included over a 5-year period. 40 subjects were allocated to VCE and 39 to E (of push type). Overall, 76.0% presented with overt bleeding. At baseline, 24.1% were taking ASA, 11.4% an anticoagulant, and 2.5% an NSAID; 76.7% of patients had a nuclear scan, and 37.0% an angiography. No significant differences were noted in baseline characteristics between the two groups. At least one lesion was detected in 72.5% of the VCE group compared to 48.7% in the E group (p=0.03); they were believed to be the source of bleeding in 79.3% and 35.0% (p=0.002), respectively. Although detection rates were similar for gastric and duodenal findings, VCE performed better in the first and second parts of the jejunum (50% vs. 10.3% P=0.0001, and 40% vs. 2.6% P<0.0001). No disparities were observed in terms of the nature of the lesions found between the two modalities. Mean duration of follow-up was 289.0±118.8 days, with 50.0% requiring a blood transfusion (42.5% VCE vs. 57.9% E, with a mean of 2.9 ± 5.0 units (VCE: 2.8±4.3 units vs. E: 3.0±5.6 units, P=NS)). Hospitalization for bleeding or continued bleeding occurred in 40.0% of VCE and in 53.9% of E patients (P=NS) (mean stay: 11.0±11.9 and 18.5±28.2 days respectively, P=NS). Crossovers occurred more frequently from E to VCE than from VCE to E (48.7% vs. 22.5%, P=0.015). Conclusions: VCE increases diagnostic yield in OGB when compared to E, especially when the bleeding source is in the jejunum. However, subsequent impact on clinical care was not significantly better in this trial although trends favored the VCE group. More crossovers were noted from E to VCE than conversely. Overall, our data support the use of VCE over E following an initial work-up in patients with OGB.

Canadian Association of Gastroenterology Position Statement on the Impact of Simethicone on Endoscope Reprocessing

Abstract A recent study by Ofstead et al. published in the American Journal of Infection Control described the presence of residual simethicone and non-pathogenic bacterial colonization in endoscopes despite adherence to reprocessing procedures(1). These findings received significant media attention, in part because they were released following a warning issued by the Food and Drug Administration and the Centre for Disease Control regarding the potential transmission of multi-drug resistant bacteria associated with the use of duodenoscopes(2, 3). In light of the findings described by Ofstead et al., the Canadian Association of Gastroenterology (CAG) would like to update its members on what is currently known.