Gastrostomy Tube RuptureNCT01698827
Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
An observational study of Gastrostomy Tube Rupture and Gastrostomy Tube Durability, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastrostomy Tube Rupture, Gastrostomy Tube Durability, Gastrostomy Tube Convenience
- What is being tested?
- Tube assessment visits
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2012to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults on long-term nutritional care requiring prolonged gastrostomy feeding via percutaneous endoscopic gastrostomy
Who may be able to join
- Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia.
- registered at the outpatient endoscopy service
- clinical stable and with the possibility of returning for scheduled visits
- expected duration of enteral feeding > 6 months
Who cannot join
- Sepsis,
- shock,
- coma,
- other types of digestive access (surgical gastrostomy, jejunostomy)
- terminal disease,
- lack of cooperation,
- refusal to participate in the protocol
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
São Paulo, São Paulo, 05403-900
Hospital das Clinicas
São Paulo, São Paulo, 05403900
About this study
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.
Read the detailed description
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.
- Being tested
- Tube assessment visits
- Keywords
- gastrostomy, tube, endoscopic, replacement, tube rupture, durability, tube loss, balloon rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube assessment visitsOther
Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo | 20 patients managed by "Kangaroo" gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. Receives: Other: Tube assessment visits | |
| Cook | 20 patients receiving "Wilson Cook" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. Receives: Other: Tube assessment visits | |
| Silmag | 20 patients managed by "Silmag" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. Receives: Other: Tube assessment visits | |
| Freka | 20 patients carrying "Freka" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. Receives: Other: Tube assessment visits | |
| Bard | 20 patients using the "Bard" gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. Receives: Other: Tube assessment visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tube durability
Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability.
Measured: 6 months
Secondary outcomes (1)
Tube rupture
Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrostomy Tube RuptureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Faintuch, University of Sao Paulo
- Investigators
- Joel Faintuch, MD, PhD, Study chair, Hospital das Clinicas, Sao Paulo, BrazilPaulo Sakai, MD, PhD, Study director, Hospital das Clinicas, Sao Paulo, BrazilEmanuele L Villela, MD, Principal investigator, Hospital das Clinicas, Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698827
- Sponsor's protocol ID
- Gastrotubes5A
- Status last verified
- Sep 2012
- First submitted
- 22 Sep 2012
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.
PubMed 21429018Villela EL, Sakai P, Almeida MR, Moura EG, Faintuch J. Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models. Clin Nutr. 2014 Apr;33(2):221-5. doi: 10.1016/j.clnu.2013.04.015. Epub 2013 Apr 30.
PubMed 23672806
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
- ClinicalTrials.gov ID
- NCT01698827
- Acronym / sponsor ID
- Gastrotubes5A
- Keywords
- gastrostomy, tube, endoscopic, replacement, tube rupture, durability, tube loss, balloon rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.
Detailed description
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in the market, however durability is variable. In a prospective randomized study, five commercial devices available in the market will be tested in 20 consecutive patients each,in patients submitted to long-term outpatient nutritional support. Tube performance will be observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design and material will influence outcome.This study is important because tube dysfunction and unscheduled changes are expensive troubles that disrupt the nutritional protocol and are responsible for multiple inconveniences to the patient and the caretaker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Kangaroo | – | Other: Tube assessment visits20 patients managed by "Kangaroo" gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. |
| Cook | – | Other: Tube assessment visits20 patients receiving "Wilson Cook" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. |
| Silmag | – | Other: Tube assessment visits20 patients managed by "Silmag" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. |
| Freka | – | Other: Tube assessment visits20 patients carrying "Freka" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. |
| Bard | – | Other: Tube assessment visits20 patients using the "Bard" gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults on long-term nutritional care requiring prolonged gastrostomy feeding via percutaneous endoscopic gastrostomy
Key inclusion criteria (4 listed)
- Adults undergoing long-term home enteral nutrition via percutaneous endoscopic gastrostomy due to neurologic conditions or dysphagia.
- registered at the outpatient endoscopy service
- clinical stable and with the possibility of returning for scheduled visits
- expected duration of enteral feeding > 6 months
Key exclusion criteria (7 listed)
- Sepsis,
- shock,
- coma,
- other types of digestive access (surgical gastrostomy, jejunostomy)
- terminal disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tube assessment visitsPatients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months) | Other | Bard, Cook, Freka, Kangaroo, Silmag |
Primary outcome
Tube durability
Time frame: 6 months
Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability.
1 secondary outcome
Tube rupture
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- Background: PubMed 21429018Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.
- Derived from this study: PubMed 23672806Villela EL, Sakai P, Almeida MR, Moura EG, Faintuch J. Endoscopic gastrostomy replacement tubes: long-term randomized trial with five silicone commercial models. Clin Nutr. 2014 Apr;33(2):221-5. doi: 10.1016/j.clnu.2013.04.015. Epub 2013 Apr 30.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Faintuch, MD, PhD study chair
Hospital das Clinicas, Sao Paulo, Brazil
Paulo Sakai, MD, PhD study director
Hospital das Clinicas, Sao Paulo, Brazil
Emanuele L Villela, MD principal investigator
Hospital das Clinicas, Sao Paulo, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy Tube Rupture and Gastrostomy Tube Durability, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tube durability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698827, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2012.