On the basis of a retrospective analysis of 124 patients, endoscopic therapy of WON by using LAMS is safe and effective. Creation of a large and sustained cystogastrostomy or cystoenterostomy tract is effective in the drainage and treatment of WON.
Objective: Evaluate safety and efficacy of the pose TM procedure for obesity treatment.Methods: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving 5% TBWL. The primary safety end point was incidence of reported adverse events.Results: Three hundred thirty-two subjects were randomized (active, n 5 221; sham, n 5 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 6 7.4% in lead-in, 4.95 6 7.04% in active, and 1.38 6 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P 5 0.068.
Conclusions:The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.
Background
The performance characteristics of spiral enteroscopy have not been well-described.
Objective
To determine the technical performance, diagnostic and therapeutic yields, and safety of oral spiral enteroscopy in patients with suspected or established small-bowel pathology.
Design
Prospective, multicenter, cohort study, with centralized database.
Setting
Ten U.S. tertiary-care medical centers.
Patients
This study involved 148 participants, of whom 101 were referred for obscure bleeding. All participants referred for antegrade deep enteroscopy were considered eligible.
Intervention
Spiral enteroscopy.
Main Outcome Measurements
Examination duration, depth of insertion, spiral enteroscopy findings, mucosal assessment upon withdrawal, and patient symptom assessment (day 1 and day 7 after the procedure).
Results
Spiral enteroscopy was successful in 93% of patients, with a median depth of insertion beyond the angle of Treitz of 250 cm (range 10–600 cm). The mean (± standard deviation) total procedure time was 45.0 ± 16.2 minutes for all procedures, and 35.4 minutes for diagnostic procedures. The diagnostic yield was 65%, of which 48% revealed more than one abnormality. The most common findings were angiectasias (61.5%), inflammation (7.5%), and neoplasia (6.8%). Argon plasma coagulation ablation accounted for 64% of therapeutic interventions.
Limitations
This was not a randomized, controlled trial of deep enteroscopy modalities.
Conclusion
Spiral enteroscopy appears to be safe and effective for evaluation of the small bowel. The procedure duration, depth of insertion, and diagnostic and therapeutic yields compare favorably with previously published data on other deep enteroscopy techniques such as single-balloon and double-balloon enteroscopy. Comparative studies are warranted. (Gastrointest Endosc 2010;72:992–8.)
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