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AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

Primary Purpose

Malignant Small Bowel Obstruction, Malignant Gastric Outlet Obstruction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AspireAssist device
Standard decompressive PEG tube
gastric outlet obstruction scoring system (GOOSS) questionnaire
Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Patient satisfaction and ease of use survey
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AspireAssist

Standard PEG

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of tube related complications per day
Number of tube related complications per day, including tube clogging, skin infection, dislodgement, etc.
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
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
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
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
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
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

Secondary Outcome Measures

Number of decompressions per day
Number of decompressions per day
Number of ED visits or readmissions for tube related problems
Number of ED visits or readmissions for tube related problems
Number of calls or office visits for nausea or tube related issues
Number of calls or office visits for nausea or tube related issues
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
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
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

Full Information

First Posted
March 24, 2020
Last Updated
January 30, 2023
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04375462
Brief Title
AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
Official Title
AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI left CCF
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Small Bowel Obstruction, Malignant Gastric Outlet Obstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AspireAssist
Arm Type
Experimental
Arm Description
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
Arm Title
Standard PEG
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
AspireAssist device
Intervention Description
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
Intervention Name(s)
Standard decompressive PEG tube
Intervention Description
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
Other
Intervention Name(s)
gastric outlet obstruction scoring system (GOOSS) questionnaire
Intervention Description
Gastric outlet obstruction scoring system (GOOSS) questionnaire Both groups will receive the questionnaires via a phone call
Intervention Type
Other
Intervention Name(s)
Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
Intervention Description
Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire Both groups will receive the questionnaires via a phone call
Intervention Type
Other
Intervention Name(s)
Patient satisfaction and ease of use survey
Intervention Description
Patient satisfaction and ease of use survey Both groups will receive the questionnaires via a phone call
Primary Outcome Measure Information:
Title
Number of tube related complications per day
Description
Number of tube related complications per day, including tube clogging, skin infection, dislodgement, etc.
Time Frame
at 30 days
Title
Patient satisfaction and ease of use survey scores
Description
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Time Frame
At baseline
Title
Patient satisfaction and ease of use survey scores
Description
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Time Frame
At 7 days from the date of tube placement
Title
Patient satisfaction and ease of use survey scores
Description
Patient satisfaction and ease of use survey, with scores ranging from 0-15 with lower scores corresponding to higher satisfaction with the tube
Time Frame
At 30 days from the date of tube placement
Title
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Description
Quality of life as measured by Edmonton Symptom Assessment System (ESAS), with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Time Frame
At baseline
Title
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Description
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Time Frame
At 7 days from the date of tube placement
Title
Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
Description
Quality of life as measured by ESAS, with scores ranging from 0-100 with higher scores corresponding to worse outcomes
Time Frame
At 30 days from the date of tube placement
Secondary Outcome Measure Information:
Title
Number of decompressions per day
Description
Number of decompressions per day
Time Frame
at 30 days
Title
Number of ED visits or readmissions for tube related problems
Description
Number of ED visits or readmissions for tube related problems
Time Frame
at 30 days
Title
Number of calls or office visits for nausea or tube related issues
Description
Number of calls or office visits for nausea or tube related issues
Time Frame
at 30 days
Title
Ability to eat/drink assessed via GOOSS
Description
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
Time Frame
At baseline
Title
Ability to eat/drink assessed via GOOSS
Description
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
Time Frame
At 1 week from the date of tube placement
Title
Ability to eat/drink assessed via GOOSS
Description
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
Time Frame
At 30 days from the date of tube placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alisan Fathalizadeh, MD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a feasibility study of 40 participants and IPD will not be shared

Learn more about this trial

AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

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