Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial.

BACKGROUND & AIMS: Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We investigated the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting. METHODS: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy. The treatment duration was 1 year. The primary outcome was the mean difference in the number of transfusion units (RBC + parental iron) between the octreotide and standard of care groups. Patients who received at least 1 octreotide injection or followed standard of care for at least 1 month were included in the intention-to-treat analyses. Analyses of covariance were used to adjust for baseline transfusion requirements and incomplete follow-up. RESULTS: We enrolled 62 patients (mean age, 72 years; 32 men) from 17 Dutch hospitals in the octreotide (n = 31) and standard of care (n = 31) groups. Patients required a mean number of 20.3 (standard deviation, 15.6) transfusion units and 2.4 (standard deviation, 2.0) endoscopic procedures in the year before enrollment. The total number of transfusions was lower with octreotide (11.0; 95% confidence interval [CI], 5.5-16.5) compared with standard of care (21.2; 95% CI, 15.7-26.7). Octreotide reduced the mean number of transfusion units by 10.2 (95% CI, 2.4-18.1; P = .012). Octreotide reduced the annual volume of endoscopic procedures by 0.9 (95% CI, 0.3-1.5). CONCLUSIONS: Octreotide effectively reduces transfusion requirements and the need for endoscopic therapy in patients with angiodysplasia-related anemia. CLINICALTRIALS: gov, NCT02384122.

Prospective evaluation of the motorized spiral enteroscope for previous incomplete colonoscopy.

Background and study aims A significant percentage of colonoscopies remain incomplete because of failure to intubate the cecum. The motorized spiral enteroscope (MSE) technique, originally developed for deep small bowel enteroscopy, may be an effective alternative technique in cases of incomplete examination of abnormally long colons (dolichocolon). We prospectively evaluated the success rate of cecal intubation, safety and the therapeutic consequences of using MSE after incomplete conventional colonoscopy. Patients and methods A total of 36 consecutive patients with an indication for diagnostic and/or therapeutic colonoscopy were prospectively enrolled in this multicenter trial. All patients had undergone at least one incomplete colonoscopy attributed to abnormally long colons. Patients with incomplete colonoscopy due to stenosis were excluded. Results Twenty-two men and 14 women (median age 66 years, range 35-82) were enrolled. Median procedure time was 30 minutes (range 16-50). Cecal intubation rate was 100 % and median cecal intubation time was 10 minutes (range 4-30). Abnormalities, mostly neoplastic lesions, were detected in 23 of 36 patients, corresponding to a diagnostic yield of 64 %. All these findings were in the right side of the colon and had not been described by the antecedent incomplete coloscopy. No adverse events occurred. Conclusions In case of a difficult and long colon, MSE is safe and effective for diagnostic and therapeutic colonoscopy. It may provide an attractive solution to accomplish completeness of previous incomplete colonoscopies in these patients.