CPSD for Gastrostomy

Overseen By Paul A Lorentz, MS RN RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Tobacco, Illegal drugs, Gastric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Constant Pressure Skin Disk (CPSD) for gastrostomy?

Research on skin-level gastrostomy tubes, similar to CPSD, shows they are widely accepted for maintaining nutrition support and are associated with improved outcomes in children compared to traditional tubes. However, the choice of device should be based on individual needs and circumstances. ^{1 2 3 4 5}

How does the CPSD treatment for gastrostomy differ from other treatments?

The Constant Pressure Skin Disk (CPSD) for gastrostomy is unique because it uses a skin-level, adjustable disk that maintains constant pressure, potentially reducing complications like leakage and discomfort compared to traditional gastrostomy tubes. This approach is different from other methods that may involve more invasive procedures or less adaptable devices. ^{2 6 7 8 9}

What is the purpose of this trial?

Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate healing, and reduced complication rates.

Research Team

Manpreet S Mundi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 22 or older who are about to receive a PEG tube or PEJ tube for feeding. It's not open to those who've had an enteral tube before, any gastric surgery like bariatric surgery, or used tobacco or illegal drugs in the past year.

Inclusion Criteria

Age greater than or equal to 22 years

You recently had a tube inserted through your abdomen to help with feeding or medication.

Exclusion Criteria

History of an enteral tube

History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)

You have used tobacco or illegal drugs within the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

During the procedure, the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including the durability of the CPSD and any adverse events.

180 days

Treatment Details

Interventions

• Constant Pressure Skin Disk

Trial Overview The study is examining a new type of adjustable skin disk called Constant Pressure Skin Disk (CPSD) that's part of a feeding tube setup. The goal is to see if CPSD can help with better healing and fewer complications compared to current options.

Participant Groups

Group I: Gastrostomy Tube Experimental Treatment 1 Intervention

Non-hospitalized outpatients undergoing placement of a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube) will receive the usual Standards of Care related to the placement of a GIG or GIJ tube and the Constant Pressure Skin Disk.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study involving 18 patients, the insertion of disc-retained gastrostomy tubes showed a high displacement rate of 33%, with 22% of tubes completely displacing and 11% becoming occult in the peritoneum, indicating significant concerns about their stability.

The procedure also resulted in a 22% infection rate at the stoma site, leading to the conclusion that the Monarch gastrostomy tube is unsuitable for primary placement under current protocols, prompting a request for design reassessment from the distributor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disc-retained tubes for radiologically inserted gastrostomy (RIG): not up to the job? Kibriya, N., Wilbraham, L., Mullan, D., et al.[2013]

The Freka-button gastrostomy system was found to be easy to apply and safe for long-term use, with no major complications reported during a median follow-up of 248 days across 61 placements in 50 patients.

The system had a low failure rate of 0.26 per year, with most replacements needed due to balloon failure, indicating good long-term stability for this new gastrostomy tube.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Skin-level gastrostomy -- long-term results from a prospective trial in gastric and jejunal application]. Dormann, AJ., Deppe, H., Kahl, S., et al.[2009]

In a three-year study involving 13 children undergoing chronic peritoneal dialysis, a total of 781 dietetic contacts were made, highlighting the need for frequent dietary support, especially for younger children under 5 years old who had an average of 5.9 contacts per month.

Nutritional support via gastrostomy buttons was crucial, as evidenced by significant improvements in body mass index (BMI) from -0.91 to 0.17, indicating that tailored dietary interventions can enhance growth outcomes in children receiving CPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of dietetic care in children on chronic peritoneal dialysis. Coleman, JE., Norman, LJ., Watson, AR.[2019]

In a study of 481 patients who received either low-profile buttons (LPBs) or long gastrostomy tubes (LGTs), LPBs showed significantly lower rates of tube dislodgement (3% vs. 9%) and fewer emergency room visits for tube-related issues (31.6% vs. 43.9%).

The use of LPBs resulted in better overall tube-related outcomes, indicating they are a safer option for gastrostomy tube placement compared to LGTs, without increasing the risk of complications or readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Placement of a Low-Profile Gastrostomy Button Is Safe and Associated With Improved Outcomes in Children. Cortez, AR., Warren, PW., Goddard, GR., et al.[2020]

In a study of children with severe spastic cerebral palsy who underwent long-term gastrostomy, there were minimal differences in nutritional outcomes and complications between skin-level and tube gastrostomy devices.

Caregiver satisfaction did not significantly favor one device over the other, suggesting that the choice of gastrostomy device should be based on individual assessments of the child's and family's needs rather than manufacturer claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative longitudinal study of gastrostomy devices in children. Thorne, SE., Radford, MJ.[2017]

The modified Janeway gastrostomy technique, using an auto-stapling device, resulted in a low postoperative wound infection rate of only 3.8% among 26 patients.

After a mean follow-up of 257 days, 87% of patients maintained a continent gastrostomy, indicating the procedure's effectiveness for long-term care and patient acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The continent gastrostomy. Sriram, K., Peterson, J., Bawani, MH.[2004]

The skin-level nonrefluxing gastrostomy button (GB) was tested in 90 patients (50 children and 6 adults) over 20 months, showing promising results in managing long-term feeding needs with an average duration of 8.9 months for pediatric patients.

While the GB demonstrated effectiveness, there were some complications, including leakage and mechanical defects, leading to 31 changes in 20 children, indicating that while the device is beneficial, ongoing monitoring and potential replacements are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeding gastrostomy button: experience and recommendations. Gauderer, MW., Olsen, MM., Stellato, TA., et al.[2019]

The use of a gastrostomy button device for long-term feeding in 10 children with chronic renal failure has proven effective, with 9 out of 10 achieving nutritional goals and improved growth parameters over a mean usage period of 12 months.

This method has significant advantages over traditional nasogastric tubes, including reduced stress for families and no need for surgery related to gastroesophageal reflux, making it a favorable option for managing feeding in young children with chronic renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrostomy buttons for feeding children on continuous cycling peritoneal dialysis. Watson, AR., Coleman, JE., Taylor, EA.[2004]

The Janeway permanent gastrostomy technique offers a safe and effective feeding solution for brain-damaged children who cannot eat by mouth due to muscle incoordination.

This method, which uses a mucosal-lined tube flap from the stomach wall and can be easily constructed with a GIA stapler, avoids the drawbacks of traditional Stamm gastrostomy and provides a tubeless feeding option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Janeway gastrostomy in children with cerebral palsy. McGovern, B.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Disc-retained tubes for radiologically inserted gastrostomy (RIG): not up to the job? [2013]

2. Germany pubmed.ncbi.nlm.nih.gov

[Skin-level gastrostomy -- long-term results from a prospective trial in gastric and jejunal application]. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Provision of dietetic care in children on chronic peritoneal dialysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Primary Placement of a Low-Profile Gastrostomy Button Is Safe and Associated With Improved Outcomes in Children. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A comparative longitudinal study of gastrostomy devices in children. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

The continent gastrostomy. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Feeding gastrostomy button: experience and recommendations. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Gastrostomy buttons for feeding children on continuous cycling peritoneal dialysis. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Janeway gastrostomy in children with cerebral palsy. [2019]