Moreels Tom G, Aabakken Lars, Arvanitaki Marianna, Knabe Mate, Beyna Torsten
Hepato-Gastroenterology, Cliniques Universitaires de Saint Luc, Brussels, Belgium.
Gastroenterology, Oslo University Hospital, Oslo, Norway.
Endosc Int Open. 2024 Nov 28;12(11):E1392-E1400. doi: 10.1055/a-2443-1514. eCollection 2024 Nov.
This was a prospective study of efficacy and safety of motorized spiral enteroscopy (MSE) to perform biliary endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy at five European centers. Consecutive patients with biliary indications for enteroscopy-assisted ERCP were enrolled. Objectives were technical success, adverse event (AE) rate, and patient radiation exposure. Eighty-nine patients were enrolled and one was excluded for a pancreatic indication. All participants had variations of Billroth II reconstruction (29.5%) or Roux-en-Y reconstruction (70.5%), either with naive papilla (39%) or hepaticojejunostomy (61%). Main indications were anastomotic stricture treatment and/or biliary stone removal. Enteroscopy to reach the bile duct was possible in 65 of 88 patients (74%), bile duct cannulation in 54 of 88 (61%), and therapeutic ERCP was technically successful in 48 of 88 (54%). In Billroth II variations, technical success was achieved in 13 of 26 patients (50%) compared with 35 of 62 (57%, = 0.5792 Chi square) in Roux-en-Y reconstructions (including bariatric gastric bypass). ERCP with intact papilla was successful in 17 of 34 patients (50%) compared with 31 of 54 (57%, = 0.4968 Chi square) in hepaticojejunostomy. The study was prematurely terminated July 2023 because MSE was withdrawn by the manufacturer for safety issues. Overall, in 12 of 88 patients (14%), AEs were recorded and six (7%) were considered serious. Only one serious AE was attributable to MSE enteroscopy: perforation of the proximal esophagus during enteroscope insertion. This prospective multicenter study was prematurely discontinued due to withdrawal of the MSE by the manufacturer because of safety issues. Technical success of MSE-assisted biliary ERCP in different types of surgically altered anatomy was 54%, which was lower than anticipated. There was one esophageal perforation attributable to use of MSE. (clinicaltrials.gov: NCT05129449).
这是一项在欧洲五个中心进行的前瞻性研究，旨在评估电动螺旋小肠镜（MSE）在解剖结构改变的患者中进行胆道内镜逆行胰胆管造影（ERCP）的有效性和安全性。连续纳入有小肠镜辅助ERCP胆道适应证的患者。研究目标为技术成功率、不良事件（AE）发生率和患者辐射暴露情况。共纳入89例患者，其中1例因胰腺适应证被排除。所有参与者均有毕Ⅱ式重建（29.5%）或 Roux-en-Y 重建（70.5%）的变异，乳头正常（39%）或肝空肠吻合术（61%）。主要适应证为吻合口狭窄治疗和/或胆管结石取出。88例患者中65例（74%）可行小肠镜到达胆管，88例中54例（61%）可进行胆管插管，88例中48例（54%）治疗性ERCP技术成功。在毕Ⅱ式变异中，26例患者中有13例（50%）技术成功，而在 Roux-en-Y 重建（包括减重胃旁路手术）中，62例中有35例（57%，卡方检验P = 0.5792）技术成功。乳头正常的患者中34例有17例（50%）ERCP成功，肝空肠吻合术患者中54例有31例（57%，卡方检验P = 0.4968）成功。该研究于2023年7月提前终止，因为制造商因安全问题撤回了MSE。总体而言，88例患者中有12例（14%）记录到AE，其中6例（7%）被认为严重。只有1例严重AE可归因于MSE小肠镜检查：小肠镜插入过程中近端食管穿孔。由于制造商因安全问题撤回MSE，这项前瞻性多中心研究提前终止。MSE辅助胆道ERCP在不同类型解剖结构改变患者中的技术成功率为54%，低于预期。有1例食管穿孔归因于MSE的使用。（clinicaltrials.gov：NCT05129449）
