AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Gastric Outlet Obstruction; Malignant Small Bowel Obstruction
• Intervention / Treatment: Device: AspireAssist device; Other: gastric outlet obstruction scoring system (GOOSS) questionnaire; Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire; Other: Patient satisfaction and ease of use survey; Device: Standard decompressive PEG tube

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alisan Fathalizadeh, MD; Phone Number: 1-866-223-8100; Email: TaussigResearch@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic, Case Comprehensive Cancer Center
      • Contact: Alisan Fathalizadeh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; 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
Active Comparator: 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	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of tube related complications per day	Number of tube related complications per day, including tube clogging, skin infection, dislodgement, etc.	at 30 days
Patient satisfaction and ease of use survey scores	Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube	At baseline
Patient satisfaction and ease of use survey scores	Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube	At 7 days from the date of tube placement
Patient satisfaction and ease of use survey scores	Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube	At 30 days from the date of tube placement
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)	Quality of life as measured by Edmonton Symptom Assessment System (ESAS), with scores ranging from 0-100 with higher scores corresponding to worse outcomes	At baseline
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)	Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes	At 7 days from the date of tube placement
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)	Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes	At 30 days from the date of tube placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of decompressions per day	Number of decompressions per day	at 30 days
Number of ED visits or readmissions for tube related problems	Number of ED visits or readmissions for tube related problems	at 30 days
Number of calls or office visits for nausea or tube related issues	Number of calls or office visits for nausea or tube related issues	at 30 days
Ability to eat/drink assessed via GOOSS	Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake. Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant	At baseline
Ability to eat/drink assessed via GOOSS	Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake. Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant	At 1 week from the date of tube placement
Ability to eat/drink assessed via GOOSS	Ability to eat/drink assessed via GOOSS, with scores ranging from o to 3, with higher scores indicating higher levels of oral intake. Pre and postoperative GOOSS scores will be compared using Wilcoxon signed rank test with a p <0.05 being considered significant	At 30 days from the date of tube placement

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Alisan Fathalizadeh, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Intestinal Obstruction; Pyloric Stenosis; Gastric Outlet Obstruction
• Other Study ID Numbers: CASE12219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is a feasibility study of 40 participants and IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes