Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique

NCT ID: NCT04096456

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-20
• Study Completion Date: 2025-10-01

Brief 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. 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.

Conditions

Gastrostomy; Gastrostomy Complications; Gastrostomy Tube Site Complication; Pain, Postoperative

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

CHRISTUS Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Monagas, MD

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital of San Antonio

Locations

The Children's Hospital of San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Javier Monagas, MD

Role: CONTACT

monagas@bcm.tmc.edu

210-704-4849

James Noel, MD

Role: CONTACT

jmnoel@bcm.tmc.edu

210-704-4849

Facility Contacts

Javier Monagas, MD

Role: primary

javier.monagas@christushealth.org

210-704-2686

James Noel, MD

Role: backup

james.noel@christushealth.org

210-704-2686

Other Identifiers

H-37260

Identifier Type: -

Identifier Source: org_study_id