Department of Gastroenterology and Hepatology, University Medical Center Utrecht, P. O. Box 85500, 3508 GA, Utrecht, The Netherlands.
Department of Endocrine Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.
Surg Endosc. 2018 Jun;32(6):2839-2846. doi: 10.1007/s00464-017-5989-8. Epub 2017 Dec 27.
Surgical resection of upper gastrointestinal (GI) subepithelial tumors (SETs) is associated with significant morbidity and mortality. A new over-the-scope (OTS) clip can be used for endoscopic full-thickness resection (eFTR). We aimed to prospectively evaluate feasibility and safety of upper GI eFTR with a new, flat-based OTS clip.
Consecutive patients with a gastric or duodenal SET < 20 mm were prospectively included. After identification of the lesion, the clip was placed and lesions were resected. Patients were followed for 1 month to assess severe adverse events (SAEs); 3-6 months after eFTR, endoscopy was performed.
eFTR was performed on 13 lesions in 12 patients: 7 gastric and 6 duodenal SETs. Technical success was achieved in 11 cases (85%). In all 11 cases, R0-resection was achieved. In all 6 duodenal cases and in one gastric case, FTR was achieved (64%). One SAE (pain) was observed after eFTR of a gastric SET. After eFTR of duodenal SETs, several SAEs were observed: perforation (n = 1), microperforation (n = 3), and hemorrhage (n = 1). During follow-up endoscopy, the clip was no longer in situ in most patients (7 of 10; 70%).
eFTR with this new flat-based OTS clip is feasible and effective. Although gastric eFTR was safe, eFTR in the duodenum was complicated by (micro)perforation in several patients. Therefore, the design of the clip or the technique of resection needs further refinement to improve safety of resection of SET in thin-walled areas such as the duodenum before being applied in clinical practice. Dutch trial register: NTR5023.
上消化道(GI)黏膜下肿瘤(SET)的外科切除术与较高的发病率和死亡率相关。一种新的内镜下全层切除术(eFTR)用的过内镜器械结扎夹(OTS)夹可以用于内镜下全层切除术(eFTR)。我们旨在前瞻性评估新型平底 OTS 夹在上消化道 eFTR 中的可行性和安全性。
连续纳入胃或十二指肠 < 20mm 的 SET 患者。在识别病变后,放置夹并切除病变。患者在 1 个月时进行随访以评估严重不良事件(SAE);eFTR 后 3-6 个月进行内镜检查。
12 例患者的 13 个病变进行了 eFTR:7 个胃 SET 和 6 个十二指肠 SET。11 例(85%)达到了技术成功。在所有 11 例中,均实现了 R0 切除。在所有 6 例十二指肠病变和 1 例胃病变中,均实现了内镜下全层切除术(64%)。在胃 SET 的 eFTR 后观察到 1 例 SAE(疼痛)。在十二指肠 SET 的 eFTR 后,观察到几种 SAE:穿孔(n = 1)、微穿孔(n = 3)和出血(n = 1)。在随访内镜检查中,大多数患者(7 例中的 7 例;70%)夹不再位于原位。
这种新型平底 OTS 夹的 eFTR 是可行和有效的。尽管胃 eFTR 是安全的,但在几个患者中,十二指肠的 eFTR 并发(微)穿孔。因此,在将其应用于临床实践之前,需要进一步改进夹的设计或切除术技术,以提高在十二指肠等薄壁区域切除 SET 的安全性。荷兰临床试验注册处:NTR5023。