Phase II clinical study on stent therapy for unresectable malignant XXXX (JIVROSG-0206).

@entity1 @entity548 @entity294 @entity3833 @entity158 @entity14 @entity204
PURPOSE: A phase II study of stent therapy for unresectable malignant @entity14 was conducted to ascertain the clinical efficacy, safety, and procedural feasibility. METHODS: Inclusion criteria comprised unresectable obstruction of the rectum or sigmoid colon; no other apparent stenosis; performance status by Eastern Cooperative Oncology Group  <=3; and maintained major organ function. The treatment protocol was to place an uncovered metal stent through the anus in an obstructive portion under x-ray fluoroscopic guidance. The @entity1 were followed for 4 weeks after therapy, and the degree of improvement in subjective symptoms lasting >= 2 weeks was assessed as effective when the @entity1 was decompressed with stent, or ineffective when not decompressed. Rate of clinical efficacy was defined as the proportion of effective cases. RESULTS: The @entity1 of the study comprised 33 @entity1 (13 @entity1 and 20 @entity1 ; mean age, 60 y). Rate of procedure completion was 97.0% (32/33). Treatment was effective in 27 @entity1 , ineffective in 4, and unassessable in 1, yielding a clinical efficacy rate of 81.8% (27/33). @entity204 owing to underlying disease (n=3), stent removal owing to anal @entity158 (n=1), and occlusion at another location (n=1) were noted. No recurrences were seen among clinically effective cases. Adverse reactions included grades 2 to 3 @entity294 (n=12), @entity158 (n=5), @entity548 (n=1), and @entity3833 (n=1), but no grade 4 adverse reactions or treatment-related @entity204 were identified. CONCLUSIONS: Stent therapy for unresectable malignant @entity14 is effective, safe, and feasible.
