AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

NCT04375462 | Withdrawn FDA Device

• 1 other identifier: CASE12219
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Small Bowel Obstruction; Malignant Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Number of decompressions per day

  at 30 days

• 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

  at 30 days

• Ability to eat/drink assessed via GOOSS

  At baseline

• Ability to eat/drink assessed via GOOSS

  At 1 week from the date of tube placement

Study Arms (2)

AspireAssist

EXPERIMENTAL

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; Other: gastric outlet obstruction scoring system (GOOSS) questionnaire; Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire; Other: Patient satisfaction and ease of use survey

Standard PEG

ACTIVE COMPARATOR

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

Device: Standard decompressive PEG tube; Other: gastric outlet obstruction scoring system (GOOSS) questionnaire; Other: Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire; Other: Patient satisfaction and ease of use survey

Interventions

AspireAssist device 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

AspireAssist

Standard decompressive PEG tube DEVICE

Allows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. Device is placed endoscopically 1-2 days after enrollment

Standard PEG

gastric outlet obstruction scoring system (GOOSS) questionnaire OTHER

Gastric outlet obstruction scoring system (GOOSS) questionnaire Both groups will receive the questionnaires via a phone call

AspireAssist; Standard PEG

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire OTHER

Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire Both groups will receive the questionnaires via a phone call

AspireAssist; Standard PEG

Patient satisfaction and ease of use survey OTHER

Patient satisfaction and ease of use survey Both groups will receive the questionnaires via a phone call

AspireAssist; Standard PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires; goblet cell silencer inhibitor

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alisan Fathalizadeh, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: May 5, 2020
• Study Start: February 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)