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临床试验/NCT04151030
NCT04151030已完成不适用

Endoscopic Direct-PEG Placement in Patients Unable to Undergo Pull-PEG Procedure

Kansas City Veteran Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Technical success of endoscopic vs radiographic Push-PEG placement in patients who are not candidates for a Pull-PEG placement

研究概览

简要总结

Placement of a feeding tube through a gastrostomy can be performed endoscopically or radiologically. While percutaneous endoscopic gastrostomy (PEG) tube placement is most frequently performed using a "pull" technique, this method may not feasible in patients with malignant, or tight benign, esophageal stenosis. Further, the "pull" technique may drag tumor cells with the feeding tube and lead to implantation metastasis at the gastrostomy site. A clinical practice update by the American Gastroenterological Association has recommended that the pull-through PEG placement method should be avoided in all patients with oropharyngeal or esophageal cancer. It also recommends that the introducer/Push PEG method should be favored instead of the pull PEG. In such situations, an introducer-style, "Direct" gastrostomy tube can be placed endoscopically or radiologically. However, the published data comparing outcomes and safety of endoscopic "Direct" PEG (D-PEG) and interventional radiological PEG (IR-PEG) are very sparse.

The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates greater control and allows safe selection of gastrostomy site. Further, the presence of an endoscope enables transillumination to confirm the absence of intervening abdominal viscera between the abdominal wall and the anterior wall of the stomach. These advantages are lacking with the IR-PEG. We hypothesize that D-PEG is safer than IR-PEG.

In this single center, non-randomized study, patients unable to undergo a conventional per-oral "Pull" PEG and needing a D-PEG will be prospectively enrolled. For the comparison arm, historical IR-PEG procedures at our center will be assessed. The technical success and rates of adverse events will be compared between the two arms. Approval from the Institutional review board has been obtained. Based on our experience, we estimate a sample size of 40 participants in each arm and anticipate completion of this pilot study by June 2021.

详细描述

Introduction Percutaneous endoscopic gastrostomy (PEG) tube placement is a frequently performed procedure to provide enteral nutrition in patients with dysphagia. Two methods are used for placing a PEG tube via the mouth: The "Pull" method and the "Push" method(1). In the "Pull" technique, the feeding tube is pulled from the mouth, through the esophagus and stomach to the outside. In the introducer-style "Direct" technique, the feeding tube is pushed from the outside to inside the stomach. Both these techniques are considered safe, effective, and have their own advantages and disadvantages(2).

Limitations of Pull PEG technique The "Pull" PEG technique is challenging in patients with head and neck malignancies, obstructing esophageal cancers, and laryngeal malignancies. The severe stenosis often precludes the passage of the adult endoscope as well as the large internal bumper of the feeding tube which must be pulled through the stenotic upper gastrointestinal tract. Further, microorganisms and malignant cells from the oropharynx/ esophagus can be pulled by the feeding tube leading to peristomal infections as well as metastatic deposits at the site of the gastrostomy(3,4). A prospective evaluation of "Pull" PEGs placed in patients with oropharyngeal and esophageal tumors revealed metastatic deposits of malignant cells in 9.5% of patients, 16 weeks after the PEG(5). Retrospective assessment of PEG placement for oropharyngeal cancer demonstrated abdominal wall metastasis of 0.64%(6).

Direct PEG technique The endoscopic Direct PEG (D-PEG) uses the Russel introducer technique which obviates the passage of the gastrostomy tube through the oropharynx. Further, it can also be performed with an ultrathin endoscope which is easy to navigate through stenotic or malignant upper gastrointestinal tract obstructions. The D-PEG requires performance of gastropexy (attachment of gastric wall to the abdominal wall using sutures) with anchor-like T-fasteners for easy and safe placement of the PEG tube(2).

The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates greater control and allows safe selection of gastrostomy site. It also obviates the need for ionizing radiation. Further, the endoscope enables transillumination to confirm the absence of intervening abdominal viscera between the abdominal wall and stomach. These advantages are lacking in IR-guided PEG which does not offer endoscopic visualization of the gastric lumen.

Currently, patients who fail a per-oral Pull PEG tube placement are typically referred for IR-guided PEG placement(3). Thus, patients who fail a "pull" PEG procedure, are referred to IR for a second invasive procedure. However, with the availability of the D-PEG, patients failing a "Pull" PEG can undergo a PEG placement during the index procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

  • Placement of PEG tube for dysphagia
  • Inability of participant to undergo conventional Pull PEG (for any reason)
  • Attempt at placement of a Push PEG
  • Age > 18 years and able to consent

排除标准

  • Successful placement of Pull PEG
  • Ascites, pregnancy

结局指标

主要结局

Technical success of endoscopic vs radiographic Push-PEG placement in patients who are not candidates for a Pull-PEG placement

时间窗: 30 days

Successful placement of PEG

次要结局

  • Procedure duration between endoscopic push PEG placement and IR guided push PEG placement(At the time of procedure)
  • Incidence of adverse events between endoscopic push PEG placement and IR guided push PEG placement(30 days)

研究者

发起方
Kansas City Veteran Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Divyanshoo Kohli

Physician, gastroenterology

Kansas City Veteran Affairs Medical Center

研究点 (2)

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