Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA, USA.
Department of Gastroenterology, Dankook University Hospital, Dankook University College of Medicine, 201 Manghyang-ro, Dongnam-gu, Cheonan, 31116, Korea.
Dig Dis Sci. 2022 Jun;67(6):2327-2336. doi: 10.1007/s10620-021-07270-1. Epub 2021 Oct 31.
Although released only for drainage of pseudocyst and walled-off necrosis (WON) with ≤ 30% solid debris, the utilization of lumen-apposing metal stent (LAMS) in "real-world" practice has deviated from approved indications. We evaluated the contemporary use of LAMS and associated clinical, procedural outcomes in the setting of a tertiary referral center in the USA.
Data from 303 consecutive patients who underwent LAMS placement were analyzed. Outcomes included technical and clinical success rates and adverse events.
Of 303 patients, 190 (62.7%) received LAMS for off-label indications. The latter included gallbladder drainage (n = 56, 18.5%), gastroenterostomy (n = 52, 17.2%), treatment of gastrointestinal strictures (n = 37, 12.2%), biliary drainage (n = 20, 6.6%), temporary gastric access for endoscopy (n = 13, 4.3%), symptomatic WON with > 30% solid debris (n = 8, 2.6%), and miscellaneous (n = 4, 1.3%). Technical success rates in the on- and off-label arm were 98.2% and 95.8%, respectively (P = .331; 95% CI 0.08 to 1.96). Clinical success rates in the on- and off-label arm were 89.4% and 83.2%, respectively (P = .137; 95% CI 0.28 to 1.19). The rate of adverse events was 20.5% (n = 39) in the off-label arm and 16.8% (n = 19) in the on-label arm (P = .242; 95% CI 0.69 to 2.34).
Off-label use of LAMS out-numbered on-label use in our practice. The safety profile between the groups was similar and with the exception of refractory stricture treatment, efficacy was comparable.
尽管仅批准用于引流最大直径≤30%实体性坏死组织的假性囊肿和隔离坏死（WON），但在“真实世界”实践中，使用腔内吻合金属支架（LAMS）已偏离了适应证。我们评估了美国一家三级转诊中心使用 LAMS 的当代情况及其相关的临床、操作结果。
对 303 例连续接受 LAMS 治疗的患者进行数据分析。结果包括技术和临床成功率以及不良事件。
在 303 例患者中，有 190 例（62.7%）因适应证外的原因接受 LAMS 治疗。后者包括胆囊引流（56 例，18.5%）、胃肠吻合术（52 例，17.2%）、治疗胃肠道狭窄（37 例，12.2%）、胆管引流（20 例，6.6%）、内镜下临时胃接入（13 例，4.3%）、最大直径＞30%实体性坏死组织的有症状 WON（8 例，2.6%）和其他情况（4 例，1.3%）。适应证内和适应证外技术成功率分别为 98.2%和 95.8%（P=0.331；95%CI，0.08 至 1.96）。适应证内和适应证外临床成功率分别为 89.4%和 83.2%（P=0.137；95%CI，0.28 至 1.19）。适应证外组的不良事件发生率为 20.5%（39 例），适应证内组为 16.8%（19 例）（P=0.242；95%CI，0.69 至 2.34）。
在我们的实践中，适应证外使用 LAMS 超过了适应证内使用。两组的安全性相似，除难治性狭窄治疗外，疗效相当。
