Clinical trial NCT04375462: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Malignant Small Bowel Obstruction
Malignant Gastric Outlet Obstruction
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of tube related complications per day
timeFrame: at 30 days
measure: Patient satisfaction and ease of use survey scores
timeFrame: At baseline
measure: Patient satisfaction and ease of use survey scores
timeFrame: At 7 days from the date of tube placement
measure: Patient satisfaction and ease of use survey scores
timeFrame: At 30 days from the date of tube placement
measure: Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
timeFrame: At baseline
measure: Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
timeFrame: At 7 days from the date of tube placement
measure: Quality of life as measured by Edmonton Symptom Assessment System (ESAS)
timeFrame: At 30 days from the date of tube placement
Secondary outcomes:
measure: Number of decompressions per day
timeFrame: at 30 days
measure: Number of ED visits or readmissions for tube related problems
timeFrame: at 30 days
measure: Number of calls or office visits for nausea or tube related issues
timeFrame: at 30 days
measure: Ability to eat/drink assessed via GOOSS
timeFrame: At baseline
measure: Ability to eat/drink assessed via GOOSS
timeFrame: At 1 week from the date of tube placement
measure: Ability to eat/drink assessed via GOOSS
timeFrame: At 30 days from the date of tube placement
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Alisan Fathalizadeh, MD
role: PRINCIPAL_INVESTIGATOR
References: