Asian Institute of Gastroenterology, Hyderabad, India.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Roma, Italia.
Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients.
Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS vs FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events.
Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs FCSEMS, respectively, stricture resolution status at 24 months was 77.1% (54/70) vs 75.8% (47/62) (P = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .568), including cholangitis/fever/jaundice (9 vs 7 patients respectively), abdominal pain (5 vs 5), cholecystitis (1 vs 3) and post-ERCP pancreatitis (0 vs 2). No stent- or procedure-related deaths occurred.
Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.).
良性胆道狭窄（BBS）是慢性胰腺炎（CP）的并发症。对于这些患者的胆道梗阻症状，使用多个塑料支架（MPS）或全覆膜自膨式金属支架（FCSEMS）进行内镜下治疗是可接受的治疗选择。
患有症状性 CP 相关 BBS 的患者参加了一项多中心随机非劣效性试验，比较了 12 个月 MPS 与 FCSEMS 治疗的疗效。主要结局为 24 个月时的狭窄缓解情况，定义为无再狭窄且 24 个月时血清碱性磷酸酶不超过支架置入完成时水平的两倍。次要结局包括交叉率、内镜逆行胰胆管造影（ERCP）和支架数量，以及支架或手术相关严重不良事件。
84 例患者被随机分配至 MPS 组，80 例患者被分配至 FCSEMS 组。MPS 的基线技术成功率为 97.6%，FCSEMS 的成功率为 98.6%。11 例 MPS 患者交叉至 FCSEMS 组，10 例 FCSEMS 患者交叉至 MPS 组。MPS 组和 FCSEMS 组在 24 个月时的狭窄缓解情况分别为 77.1%（54/70）和 75.8%（47/62）（意向治疗分析中 P=0.008 表示非劣效性），平均 ERCP 次数分别为 3.9±1.3 次和 2.6±1.3 次（P<0.001，意向治疗），平均支架放置数量分别为 7.0±4.4 个和 1.3±0.6 个（P<0.001，实际治疗）。MPS 组和 FCSEMS 组分别有 16 例（19.0%）和 19 例（23.8%）患者发生严重不良事件（P=0.568），包括胆管炎/发热/黄疸（分别为 9 例和 7 例患者）、腹痛（5 例和 5 例）、胆囊炎（1 例和 3 例）和 ERCP 后胰腺炎（0 例和 2 例）。无支架或手术相关死亡事件发生。
对于 CP 相关 BBS 的内镜治疗，12 个月的 MPS 治疗与单个 FCSEMS 治疗具有相似的疗效和安全性，2 年内 FCSEMS 需要的 ERCP 次数更少。（临床试验.gov，编号：NCT01543256.）
Zotero 插件