Tringali Andrea, Vadalà di Prampero Salvatore Francesco, Landi Rosario, Bove Vincenzo, Familiari Pietro, Hamanaka Jun, Attili Fabia, Costamagna Guido
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli - IRCCS, Catholic University, Rome, Italy; CERTT, Centre for Endoscopic Research, Therapeutics and Training - Catholic University, Rome, Italy.
Department of Gastroenterology and GI Endoscopy, University Hospital of Udine, Italy; Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli - IRCCS, Rome, Italy.
Gastrointest Endosc. 2018 Dec;88(6):939-946. doi: 10.1016/j.gie.2018.08.019. Epub 2018 Aug 22.
Symptomatic main pancreatic duct (MPD) strictures secondary to chronic pancreatitis (CP) may benefit from endoscopic insertion of single or multiple plastic stents. MPD stricture resolution after single plastic stent removal is uncommon. The use of removable fully covered, self-expandable metal stents (FC-SEMSs) to dilate MPD strictures secondary to CP was evaluated.
Patients with CP and symptomatic MPD stricture located in the head of the pancreas persisting for 3 months or more after placement of a single plastic stent were enrolled in a prospective single-arm trial. A nitinol FC-SEMS was inserted and removed after 6 months. The FC-SEMS diameter and length were chosen according to the stricture anatomy and MPD diameter above the stricture. Our primary objective was FC-SEMS removability. Secondary outcomes were MPD stricture resolution rate and adverse events.
Between December 2012 and October 2014, 15 patients (10 male, mean age 60 years) were enrolled. Pancreatic calcifications were present in 6 (40%) patients. Four patients (27%) had a history of alcohol abuse. In 10 patients, the FC-SEMS was inserted through the major papilla, whereas 5 patients (3 pancreas divisum, 2 dominant dorsal duct) received the stent through the minor papilla. One patient developed cholangitis after 24 hours due to occlusion of the biliary sphincterotomy from the FC-SEMS; cholangitis resolved after insertion of a plastic biliary stent. Complete distal migration of the FC-SEMS was reported in 7 patients (47%) (5 asymptomatic, 2 symptomatic with recurrence of pancreatitis). All migrations occurred with the 3-cm-long FC-SEMS. Four patients (27%) developed de novo stricture induced by the FC-SEMS at the level of the flared end and were excluded from the follow-up; 1 patient with FC-SEMS migration had failed stricture resolution. One patient was lost to follow-up. Finally, 9 patients with MPD stricture resolution had a mean follow-up of 38.9 months (range, 5.3-55.3 months), and 89% were asymptomatic.
FC-SEMS removability from the MPD in CP was feasible in all cases, and 90% of the patients were asymptomatic after 3 years. Migration seems more frequent with the 3-cm-long FC-SEMS. Occurrence of FC-SEMS-induced pancreatic strictures is a major issue and deserves further assessment. According to our experience, pancreatic FC-SEMSs have promising results, but a careful evaluation in the setting of clinical trials is needed.
慢性胰腺炎（CP）继发的有症状的主胰管（MPD）狭窄可能受益于内镜下插入单个或多个塑料支架。单个塑料支架取出后MPD狭窄缓解并不常见。本研究评估了使用可取出的全覆膜自膨式金属支架（FC-SEMS）扩张CP继发的MPD狭窄的效果。
将CP且有症状的MPD狭窄位于胰头、单个塑料支架置入后持续3个月或更长时间的患者纳入一项前瞻性单臂试验。插入一枚镍钛合金FC-SEMS，6个月后取出。根据狭窄部位的解剖结构和狭窄上方MPD的直径选择FC-SEMS的直径和长度。我们的主要目标是FC-SEMS的可取出性。次要结局是MPD狭窄缓解率和不良事件。
2012年12月至2014年10月，共纳入15例患者（10例男性，平均年龄60岁）。6例（40%）患者存在胰腺钙化。4例（27%）有酗酒史。10例患者通过主乳头插入FC-SEMS，5例患者（3例胰腺分裂症、2例主导背侧胰管）通过副乳头置入支架。1例患者在24小时后因FC-SEMS阻塞胆管括约肌切开处而发生胆管炎；插入塑料胆管支架后胆管炎缓解。7例患者（47%）报告FC-SEMS完全向远端迁移（5例无症状，2例有胰腺炎复发症状）。所有迁移均发生在3 cm长的FC-SEMS。4例患者（27%）在扩张端水平出现由FC-SEMS引起的新发狭窄，被排除在随访之外；1例FC-SEMS迁移患者狭窄缓解失败。1例患者失访。最后，9例MPD狭窄缓解患者平均随访38.9个月（范围5.3 - 55.3个月），89%无症状。
CP患者MPD中FC-SEMS的取出在所有病例中都是可行的，90%的患者在3年后无症状。3 cm长的FC-SEMS迁移似乎更频繁。FC-SEMS引起的胰腺狭窄的发生是一个主要问题，值得进一步评估。根据我们的经验，胰腺FC-SEMS有良好的结果，但需要在临床试验中进行仔细评估。
