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临床试验/NCT04362605
NCT04362605已完成不适用

Case Series of Combined Endoscopic Negative Pressure Therapy and Surgical Treatment of Anastomotic Insufficiencies After Oncological Gastrectomies

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
mortality rate

研究概览

简要总结

Background and study aims: Management of esophago-jejunal anastomotic leackages (EJAL) after gastric resections is challenging. Endoscopic negative pressure therapy (ENPT) is an emerging effective tool for treatment of gastrointestinal and anastomotic leaks. We use ENPT for EJAL after oncological gastric resections as first line therapy since 2018. The aim of the study was to present our results with this strategy by a case series.

Patients and methods: Eight patients were treated with ENPT for EJAL after oncological gastric resections between 01.2018 and 12.2019. A retrospective analysis of patient's and therapy related data was performed.

Results: Time of detection was 6.25 ± 2.54 days after surgery. After 15.63 ± 9.92 days of ENPT, 6.43 ± 3.66 endoscopies and 38.75 ± 17.35 days of hospitalization, endoscopic treatment with ENPT combined with minimal-surgery for sepsis-control was effective in seven of eight patients. In one patients treatment was changed to Stent-based therapy combined with further surgical interventions.

Conclusions: ENPT is one step in the complication management of patients with anastomotic insufficiencies after oncological gastric resections. It can be recommended in combination with minimal invasive surgery for sepsis-control. Success of ENPT for EJAL seams to be dependent on the age and size of the insufficiency and the clinical situation of the patient.

详细描述

Endoscopic negative pressure therapy (ENPT):

OPD: The commercially available Eso-SPONGE® System (B. Braun Melsungen AG, Melsungen, Germany) was used for endoluminal vacuum therapy. For positioning the OPD in loop-technique a loop (MersileneTM, Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) is fixed at the distal end of the drainage, gripped with an endoscopic grasper and placed under endoscopic view. Endoscopic placement took place via oral intubation of the esophagus with finally oro-nasal redirection and fixation with plasters.

OFD: The OFD for endoluminal therapy is handmade, as previously described, by wrapping a thin open-pore double-layered drainage film (Suprasorb® CNP, Drainage Film; Lohmann & Rauscher International GmbH & Co.KG, Rengsdorf, Germany) on the distal end of a small caliber redon drain, a gastric tube or the gastric segment of a naso-jejunal feeding tube (Freka® Trelumina, Fresenius Kabi Deutschland GmbH, Bad Homburg Germany). Sutures (MersileneTM, Polyester, 4 Ph. Eur., Ethicon®, Norderstedt, Germany) were used for the fixation of the drainage film around the tube. Drain insertion took place via nasal positioning and endoscopic guiding with grasper. Venting tubes in tri-lumen enteral feeding tubes has to be closed for ENPT.

Controlled Negative Pressure: A continuous vacuum of -125 mmHg is generated by electronic vacuum devices (KCI V.A.C. Ulta or V.A.C. Freedom; KCI USA Inc., San Antonio, TX, USA).

Procedural informations: In patients with suspected EJAL first an index endoscopy under general anesthesia with endotracheal intubation was indicated. Standard gastroscopes with outer diameter of 9.8mm were used with carbon dioxide insufflation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • anastomotic leak after oncological gastrectomy

排除标准

  • all other patients

结局指标

主要结局

mortality rate

时间窗: 30 days after surgery

death by anastomotic leak

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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