NCT04375462

AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This multicentered study will enroll participants into two cohorts of (study and control groups). The study group will undergo AspireAssist gastrostomy tube placement and the control group will undergo standard decompressive percutaneous gastrostomy tube placement. Individuals who present for venting gastrostomy placement in clinic or as consults will be approached for inclusion. Gastrostomy tubes will be placed 1-2 days after enrollment to allow for thoroughly consideration of inclusion by potential participants. Gastrostomy tube placement will be completed endoscopically in the standard "pull" method in both the AspireAssist and PEG groups. Questionnaires will be completed at 7 and 30 days. The primary objective of this study is to evaluate to compare healthcare utilization, including major and minor tube related complications between the two groups. Secondary objectives of this study are to compare changes in the ability to eat and drink after placement of the gastrostomy tube and to evaluate changes in quality of life before and after gastrostomy tube placement.

Conditions

• Malignant Small Bowel Obstruction
• Malignant Gastric Outlet Obstruction

Interventions

Type	Name	Description
DEVICE	AspireAssist device	Allows for aspiration of gastric contents into a receptacle or the toilet to prevent symptoms of nausea, vomiting, and to prevent aspiration. Device is placed endoscopically in an identical fashion to a standard PEG tube G 1-2 days after enrollment
DEVICE	Standard decompressive PEG tube	Allows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. Device is placed endoscopically 1-2 days after enrollment
OTHER	gastric outlet obstruction scoring system (GOOSS) questionnaire	Gastric outlet obstruction scoring system (GOOSS) questionnaire Both groups will receive the questionnaires via a phone call
OTHER	Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire	Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire Both groups will receive the questionnaires via a phone call
OTHER	Patient satisfaction and ease of use survey	Patient satisfaction and ease of use survey Both groups will receive the questionnaires via a phone call

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2020-05-05
• Last updated: 2023-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study