AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

NCT ID: NCT04375462

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-08-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

AspireAssist

Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days, and the AspireAssist group will have a clinic visit at 7 days to have the skin-port placed.

All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube

Group Type: EXPERIMENTAL

AspireAssist device

Intervention Type: 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

gastric outlet obstruction scoring system (GOOSS) questionnaire

Intervention Type: OTHER

Gastric outlet obstruction scoring system (GOOSS) questionnaire

Both groups will receive the questionnaires via a phone call

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

Intervention Type: OTHER

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

Both groups will receive the questionnaires via a phone call

Patient satisfaction and ease of use survey

Intervention Type: OTHER

Patient satisfaction and ease of use survey

Both groups will receive the questionnaires via a phone call

Standard PEG

Gastrostomy tubes will be placed 1-2 days after enrollment. Questionnaires will be completed at 7 and 30 days All participants will be placed on a diet consisting of liquids and soft foods to prevent clogging of the gastrostomy tube

Group Type: ACTIVE_COMPARATOR

Standard decompressive PEG tube

Intervention Type: DEVICE

Allows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration.

Device is placed endoscopically 1-2 days after enrollment

gastric outlet obstruction scoring system (GOOSS) questionnaire

Intervention Type: OTHER

Gastric outlet obstruction scoring system (GOOSS) questionnaire

Both groups will receive the questionnaires via a phone call

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

Intervention Type: OTHER

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire

Both groups will receive the questionnaires via a phone call

Patient satisfaction and ease of use survey

Intervention Type: OTHER

Patient satisfaction and ease of use survey

Both groups will receive the questionnaires via a phone call

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

gastric outlet obstruction scoring system (GOOSS) questionnaire

Gastric outlet obstruction scoring system (GOOSS) questionnaire

Both groups will receive the questionnaires via a phone call

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alisan Fathalizadeh, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE12219

Identifier Type: -

Identifier Source: org_study_id