CompletedNot Applicable

Complications Associated With Primary Placement of Gastrostomy for Feeding

United States43 participantsStarted 2017-12-08

Plain-language summary

The purpose of the study is to compare pain, complications, and quality of life after gastrostomy tube is placed by either percutaneous endoscopic gastrostomy (PEG) or radiologically-inserted gastrostomy (RIG) method.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Age greater than or equal to 18 years * Cannot maintain adequate nutrition by mouth Exclusion criteria: * Venting-only gastrostomy * Patients with Amyotrophic Lateral Sclerosis (ALS) * Coagulopathy with uncorrectable International Normalized Ratio (INR) greater than 1.5 or inability to hold anticoagulation * Structural abnormality that would prevent one or both techniques * Known severe esophageal stricture * Obstructing malignancy in oropharynx or esophagus that prohibits pull-through technique * Neoplastic, inflammatory, or infiltrative disease of abdominal wall or gastric wall * Known hepatomegaly * Abdominal wall mesh * Enteric functional abnormality * Small bowel or colonic obstruction * Gastric or small bowel dysmotility * Active abdominal infection/peritonitis/enterocutaneous fistula * Ascites * Ventriculoperitoneal shunt * Inpatient status * Pregnant patient

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: Before the procedure, within 24 hours after procedure, at 48-96 hours after procedure, and at 6 weeks after procedure

Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: Within 24 hours after procedure

Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 6 weeks after procedure

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 3 months, if tube still in place

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 6 months, if tube still in place

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 9 months, if tube still in place

Trial details

NCT IDNCT05173935

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-29

View on ClinicalTrials.gov More Gastrostomy Tube trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in pain with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: Before the procedure, within 24 hours after procedure, at 48-96 hours after procedure, and at 6 weeks after procedure

Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: Within 24 hours after procedure

Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 6 weeks after procedure

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 3 months, if tube still in place

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 6 months, if tube still in place

Minor complications with gastrostomy-tube placement, comparing RIG with PEG

Timeframe: At 9 months, if tube still in place