Clinical trial NCT01698827: Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
Official title: Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrostomy Tube Rupture
Gastrostomy Tube Durability
Gastrostomy Tube Convenience
Keywords: gastrostomy
tube
endoscopic
replacement
tube rupture
durability
tube loss
balloon rupture
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults on long-term nutritional care requiring prolonged gastrostomy feeding via percutaneous endoscopic gastrostomy

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Sepsis,
* shock,
* coma,
* other types of digestive access (surgical gastrostomy, jejunostomy)
* terminal disease,
* lack of cooperation,
* refusal to participate in the protocol

Primary outcomes:
measure: Tube durability
timeFrame: 6 months
Secondary outcomes:
measure: Tube rupture
timeFrame: 6 months
Other outcomes:
measure: Number of previous tube changes
timeFrame: 6 months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas
Study officials:
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
name: Joel Faintuch, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
name: Paulo Sakai, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
name: Emanuele L Villela, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Villela 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.