Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA.
Gastrointest Endosc. 2023 Mar;97(3):472-481.e3. doi: 10.1016/j.gie.2022.09.021. Epub 2022 Oct 5.
Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain.
Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent.
Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65).
Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.).
全覆膜自膨式金属支架（FCSEMS）可能为慢性胰腺炎（CP）伴扩张胰管（PD）疼痛提供一种治疗选择，但最佳患者选择和 FCSEMS 设计、疗效和安全性仍不确定。我们研究了一种用于治疗 CP 相关疼痛的新型胰 FCSEMS。
患有疼痛性 CP、主胰管下游狭窄和 PD 上游扩张的患者入组了一项前瞻性、多中心、单臂试验，研究了 6 个月留置 4-6cm 长软胰 FCSEMS 的情况。主要疗效和安全性终点分别为 FCSEMS 留置后 6 个月疼痛缓解（性能目标≥53%）和 PD 支架置入相关严重不良事件（SAE）（性能目标<32%）。主要疗效终点评估了 FCSEMS 置入时疼痛严重且频繁的患者（首次支架置入或更换为塑料支架）。
在 67 例患者（平均年龄 52.7±12.5 岁；CP 确诊后平均时间 6.4±6.4 年）中，34 例（50.7%）在 FCSEMS 置入后 90 天内放置了塑料支架，46 例符合主要疗效终点分析。技术成功率为 97.0%（65/67）。观察到的主要疗效（26.1%，12/46）和安全性终点（31.3%，21/67）未达到事先研究假设。研究支架迁移发生在 47.7%的患者（31/65）中。
6 个月的 FCSEMS 治疗并未导致预期程度的疼痛缓解，且支架迁移和 SAE 很常见。需要进一步研究以明确最佳减压策略、FCSEMS 设计和患者选择。（临床试验注册号：NCT02802020.）。
