AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
Withdrawn before enrolling · Not applicable
Conditions studied: Malignant Small Bowel Obstruction, Malignant Gastric Outlet Obstruction
In brief
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are generally uncomfortable. Gastric drainage through the use of a percutaneously placed endoscopic gastrostomy (PEG) tube has been used in people with cancer since the 1980s. This allows relief of symptoms of malignant bowel obstruction though venting of stomach contents. Decompressive PEG tubes are routinely used in individuals with malignant obstruction, although these tubes tend to get clogged from food blocking the tube. The AspireAssist is a weight loss device that allows participants to remove a large amount of the food in their stomachs after each meal to help them to lose weight via an aspiration device attached to the abdominal portion of the tube which allows instillation of water into the stomach, followed by aspiration of the gastric contents into a receptacle or the toilet. The device is placed endoscopically in an identical fashion to a standard PEG tube. Although most commonly used for weight loss, the device is FDA cleared to be used as a venting tube as well. The purpose of this study is to determine if the AspireAssist provides an improved quality of life when compared with a standard venting gastrostomy tube for participants with malignant bowel obstructions.
Key facts
- Study ID
- NCT04375462
- Run by
- Case Comprehensive Cancer Center
- People needed
- 0
- Starts
- 2023-02-01
- Expected to finish
- 2023-08-01
- Last updated by the study team
- 2023-01-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Malignant (cancer of any type) gastric or small bowel obstruction referred to surgery for placement of a venting gastrostomy tube for gastric decompression
- Able to demonstrate the ability to use the AspireAssist prior to placement
You may not qualify if…
- Those who are immobile and unable to at least sit up in bed to vent the gastrostomy tube.
- Undergoing placement of a gastrostomy tube for any other indication other than malignant small bowel or gastric outlet obstruction.
- Absolute contraindications to gastrostomy tube placement, such as occluding oral or esophageal tumors
Where it is running
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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