GastrostomyNCT04096456
Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique
An observational study of Gastrostomy and Gastrostomy Complications, run by CHRISTUS Health at 1 site in United States.
Trial summary
Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We assessed an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Gastrostomy, Gastrostomy Complications, Gastrostomy Tube Site Complication
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2015to 1 Oct 2025
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Retrospective chart review. The study population includes any patient who underwent a gastrostomy with gastropexy or primary percutaneous gastrostomy tube placement with pull through technique by the gastroenterologists at the Children's Hospital of San Antonio from 01/01/2005 - 06/26/2018.
Who may be able to join
- Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.
Who cannot join
- Patients that do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Children's Hospital of San Antonio
San Antonio, Texas, 78207
Javier Monagas, MD, 210-704-2686, javier.monagas@christushealth.org
James Noel, MD, 210-704-2686, james.noel@christushealth.org
About this study
Official title: Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique
Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We assessed an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement. The gastropexy technique is most often associated with laparoscopic procedures involving gastric volvulus or complicated GERD, but little has been published investigating the outcomes of pediatric gastrostomy tube placement with the use of the gastropexy technique.
Read the detailed description
This is a retrospective chart review. We will review charts of patients who underwent gastrostomy with gastropexy and primary percutaneous gastrostomy tube placement with pull through technique and compare immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation), and for readmission in the 3 months following placement. Our control group will be the patients with primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.
Inclusion Criteria:
Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.
Exclusion Criteria:
Patients that do not meet inclusion criteria.
Procedures: Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We will assess an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement and a low profile gastrostomy button of appropriate size is placed. We will review complications both long term and short term of both the primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.
Screening of GI cases at the Children's Hospital of San Antonio will be performed by PI and research staff to identify eligible patients. The subject record will be accessed and data recorded. The information recorded will be coded in the event a subject record requires subsequent reviews to obtain data. The subject record will be coded in order to protect subject PHI confidential. Please see section S for the data collection tool. The chart review will include records created starting 01/01/2005 - 06/26/2018.
Sample size: Local: 150, Worldwide: 150 The sample size is the any patient who underwent a gastrostomy with gastropexy or primary percutaneous gastrostomy tube placement with pull through technique by the gastroenterologists at the Children's Hospital of San Antonio.
Data Analysis: The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.
- Conditions
- Gastrostomy, Gastrostomy Complications, Gastrostomy Tube Site Complication, Pain, Postoperative
- Keywords
- Gastropexy, Endoscopic Gastropexy, Gastrostomy Tube
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate and Long Term Complications
The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.
Measured: The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start20 Aug 2015
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Javier Monagas, MD, Principal investigator, The Children's Hospital of San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096456
- Sponsor's protocol ID
- H-37260
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique
- ClinicalTrials.gov ID
- NCT04096456
- Acronym / sponsor ID
- H-37260
- Conditions
- Gastrostomy, Gastrostomy Complications, Gastrostomy Tube Site Complication, Pain, Postoperative
- Keywords
- Gastropexy, Endoscopic Gastropexy, Gastrostomy Tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 20 Aug 2015 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 19 Sep 2019 (actual)
- 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.
Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We assessed an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement. The gastropexy technique is most often associated with laparoscopic procedures involving gastric volvulus or complicated GERD, but little has been published investigating the outcomes of pediatric gastrostomy tube placement with the use of the gastropexy technique.
Detailed description
This is a retrospective chart review. We will review charts of patients who underwent gastrostomy with gastropexy and primary percutaneous gastrostomy tube placement with pull through technique and compare immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation), and for readmission in the 3 months following placement. Our control group will be the patients with primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.
Inclusion Criteria:
Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.
Exclusion Criteria:
Patients that do not meet inclusion criteria.
Procedures: Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We will assess an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement and a low profile gastrostomy button of appropriate size is placed. We will review complications both long term and short term of both the primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.
Screening of GI cases at the Children's Hospital of San Antonio will be performed by PI and research staff to identify eligible patients. The subject record will be accessed and data recorded. The information recorded will be coded in the event a subject record requires subsequent reviews to obtain data. The subject record will be coded in order to protect subject PHI confidential. Please see section S for the data collection tool. The chart review will include records created starting 01/01/2005 - 06/26/2018.
Sample size: Local: 150, Worldwide: 150 The sample size is the any patient who underwent a gastrostomy with gastropexy or primary percutaneous gastrostomy tube placement with pull through technique by the gastroenterologists at the Children's Hospital of San Antonio.
Data Analysis: The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Retrospective chart review. The study population includes any patient who underwent a gastrostomy with gastropexy or primary percutaneous gastrostomy tube placement with pull through technique by the gastroenterologists at the Children's Hospital of San Antonio from 01/01/2005 - 06/26/2018.
Key inclusion criteria (1 listed)
- Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.
Key exclusion criteria (1 listed)
- Patients that do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate and Long Term Complications
Time frame: The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018.
The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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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.
Javier Monagas, MD principal investigator
The Children's Hospital of San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrostomy and Gastrostomy Complications, run by CHRISTUS Health at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Monagas, MD (210-704-4849, monagas@bcm.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate and Long Term Complications (time frame: The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.