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临床试验/NCT03335982
NCT03335982Unknown不适用

Feasibility and Safety of Ttransendoscopic Enteral Tubing in Mid-gut

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
success rate

研究概览

简要总结

A transendoscopic enteral tubing (TET ) tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. This study aimed to evaluate the feasibility and safety of TET in mid-gut .

详细描述

In recent years, fecal microbiota transplantation (FMT) has gained appeal as a therapeutic option worldwide. Traditionally, microbiota can be administered through the upper-gut, the mid-gut, and the lower-gut pathways. FMT via colonoscopy is a classic approach, but in our previous study on ulcerative colitis, those patients have difficulty to maintain the infused microbiota suspension for enough time through this way. Thus, the investigators designed the colonic transendoscopic enteral tubing (TET) technology, which made whole-colon administration of treatment and repeat FMTs possible. However, some patients are resistant to undergo bowel preparation for colonoscopy or some are not suitable for colonic delivering way. Therefore, mid-gut delivering way is an important option for those patients. In previous researches on FMT for Crohn's disease, patients and physician faced the similar problem that some patients need repeat FMT during hospitalization, and some may need enteral nutrition at the same time. In order to have a quicker and more convenient placement of mid-gut/nasal-jejunal TET tube than traditional methods, the investigators designed a novel mid-gut TET technique without further confirmation for the location of tube in gut by X-ray or other medical devices after the endoscopic procedure. This study aimed to evaluate the feasibility, safety, and value of the mid-gut TET technique.

研究设计

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

入排标准

年龄范围
5 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild to moderate inflammatory bowel disease (Montreal classification) or suitability for endoscopy, and consented to undergo TET placement for their diseases and conditions

排除标准

  • No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.
  • With contraindication of endoscopy. Pregnant or lactating female

研究组 & 干预措施

transendoscopic enteral tubing in mid-gut

Other

A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia. The feasibility, safety, success rate, and satisfaction with TET placement were evaluated for enteral nutrition or fecal microbiota transplantation.

干预措施: transendoscopic enteral tubing in mid-gut (Procedure)

结局指标

主要结局

success rate

时间窗: All patients were followed up from date of intubation to one mouth after discharge

the success rate of of the TET procedure

adverse events rate

时间窗: All patients were followed up from date of intubation to one mouth after discharge

Procedure-related and tube-related adverse events after procedure

次要结局

未报告次要终点

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Faming Zhang

Associate professor, Gastroenterology

The Second Hospital of Nanjing Medical University

研究点 (1)

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