Intitute of Medicine, Department of Molecular and Clinical Medicine, Gothenburg University, Gothenburg, Sweden
Division of Gastroenterology, Department of Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
BMJ Open Gastroenterol. 2021 Mar;8(1). doi: 10.1136/bmjgast-2021-000612.
Fibrotic strictures in the gastrointestinal tract are frequent in Crohn's disease. Endoscopic dilation is a standard treatment. However, recurrence is common after dilation and there are complications such as bleeding or perforation. Endoscopic treatment using self-expandable metal stents has shown diverging results. The aim of this study was to evaluate the outcome of endoscopic treatment with a self-expandable stent in ileocecal Crohn's disease.
DESIGN/METHOD: Patients with Crohn's disease and a symptomatic ileocecal stricture were eligible for prospective, consecutive inclusion in a single-centre setting. Patients were randomised to treatment with either 18 mm balloon dilatation (Group) or stenting (Group) using a 20 mm diameter, partially covered Hanarostent NCN. Patients were followed for a minimum of 24 months postendoscopy. Outcomes were technical success, adverse events and clinical success (defined as no need for repeated interventions).
Thirteen patients (Group n=6; Group=7) were included with twelve patients (Group n=5; Group=7) being eligible for complete follow-up. Technical success was achieved in all cases. Adverse events were border-line significantly more common in the Group: 4/7 (57%) (pain: n=3; pain and rectal bleeding: n=1) compared with the Group: 0/5 (0%), p=0.08, which resulted in preterm termination of the study. The clinical success rate was Group: 6/7 (86%) vs Group: 1/5 (20%), p=0.07.
Patients with strictures related to Crohn's disease may benefit from treatment with self-expandable metal stents rather than dilatation. However, there seems to be an increased risk for patient pain after stenting, which has to be considered and handled.
The study was registered at Clinical Trials (NCT04718493).
胃肠道纤维化性狭窄在克罗恩病中较为常见。内镜扩张是一种标准的治疗方法。然而，扩张后复发较为常见，且存在出血或穿孔等并发症。使用自膨式金属支架进行内镜治疗的效果存在差异。本研究旨在评估自膨式支架在回盲部克罗恩病中的内镜治疗效果。
设计/方法：患有克罗恩病且存在症状性回盲部狭窄的患者符合前瞻性、连续纳入单中心研究的条件。患者被随机分为接受 18mm 球囊扩张（组）或使用 20mm 直径、部分覆盖 Hanarostent NCN 的支架治疗（组）。所有患者在内镜治疗后至少随访 24 个月。观察指标包括技术成功率、不良事件和临床成功率（定义为无需重复干预）。
共纳入 13 例患者（组 n=6；组 n=7），其中 12 例（组 n=5；组 n=7）患者可进行完整随访。所有病例均达到技术成功。不良事件在组中更为常见：4/7（57%）（疼痛：n=3；疼痛和直肠出血：n=1），而在组中无不良事件（0/5，0%），p=0.08，这导致研究提前终止。组的临床成功率为 6/7（86%），而组为 1/5（20%），p=0.07。
患有与克罗恩病相关的狭窄的患者可能从自膨式金属支架治疗中获益，而不是扩张治疗。然而，支架治疗后患者疼痛的风险似乎增加，这需要加以考虑和处理。
该研究在临床试验（NCT04718493）注册。
