AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

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.

Conditions

• Malignant Small Bowel Obstruction
• Malignant Gastric Outlet Obstruction

Interventions

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Alisan Fathalizadeh, MD · Cleveland Clinic, Case Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2023-07-01

Completion

2023-08-01

FDA Device

Yes

Countries

• United States

Study Locations