PRG With and Without Gastropexy

Gastrostomy Clinical Trial

Official title:

Percutaneous Radiologic Gastrostomy With and Without Gastropexy: A Prospective Comparison

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107974
• Other study ID #: 18-5102
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 11, 2019

Study information

• Verified date: September 2019
• Source: University Health Network, Toronto
• Contact: Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR
• Phone: : (416) 340-4800
• Email: Ganesan.Annamalai[@]sinaihealthsystem.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Percutaneous (through the skin) radiologic (x-ray guided) gastrostomy (to the stomach) (PRG) is a common procedure performed to help provide supplemental nutrition for those for who have difficulty swallowing their food. This population typically includes patients receiving radiation therapy for cancers of the mouth or throat, patients who have had a stroke or other neurologic disorders. It involves making a small incision in the skin on the belly to insert a feeding tube directly into the stomach. PRG has been well established as a safe and effective procedure for many years now. Although known to be safe, there is still debate regarding the best way to perform the procedure. Some doctors believe it is necessary to stitch the stomach wall against the wall of the belly before inserting the tube, this is called gastropexy. They argue that this decreases the risk of the tube being positioned incorrectly and prevents leakage of stomach content in the first few weeks after the procedure. Other doctors feel that these risks are very small and this step is not required as it can cause the patient more pain in the days following the procedure since the stomach is fixed against the body wall and cannot move naturally. To this day, the procedure is performed safely both ways, depending on the hospital.

The purpose of this research study is to compare these two methods and determine if one technique gives better results, meaning less pain and fewer complications for patients.

Description:

When percutaneous radiological gastrostomy (PRG) first emerged as an alternative method to surgical or endoscopic techniques, gastropexy was considered an essential step. This consists of using sutures and "T-fasteners" to fix the anterior gastric wall to the anterior abdominal wall and many variations are described in the literature. It was postulated that this step is necessary to avoid tube misplacement and peritonitis caused by early leakage of gastric content around the site of tube insertion. It is still considered imperative in some groups of patients at high risk of gastric leakage (i.e. patients with ascites, steroid treatment, and/or severe malnourishment). However, in other patients its use has become subject of debate.

Experiments with animal models have shown no evidence of gastric leakage following insertion of a 14 French tube, even when the tube is subsequently removed and the defect left unrepaired. Furthermore, several groups have had success without the use of gastropexy and some have described complications caused by performing this step such as peristomal infection, increased post-procedural pain, persistent leakage, and gastrocutaneous fistulas. Other large series of patients who underwent gastrostomy with gastropexy did not experience gastropexy-related complications, further complicating the matter. To date, the guidelines for transabdominal gastrostomy published by the Society of Interventional Radiology (SIR) and American Gastroenterological Association (AGA) acknowledge both techniques but have no official recommendation on the use of gastropexy reflecting the lack of clear evidence regarding advantage with or without its use.

The investigators hypothesize that the use of gastropexy for PRG does not significantly decrease complications.

The investigators also hypothesize that the use of gastropexy is associated with increased post procedural pain.

At the investigators' institution (University Health Network) PRG without gastropexy is regularly performed first-line for gastrostomy. There is a high volume of requests for PRG and thus establishing which method is superior will help to reduce the number of complications and revisions. In doing so, the investigators hope to be able to establish an optimal evidence-based protocol for PRG for future patients as well as improving patient safety and satisfaction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (age 18 years and older) meeting standard eligibility criteria for percutaneous radiologic gastrostomy

• Dysphagia related to malignancy or surgery/radiation therapy

• Able to appropriately understand and complete English questionnaires either independently or with the assistance of a translator

Exclusion Criteria:

• Unable to provide informed consent

• Unable or unwilling to complete the pre and post-procedure questionnaires

• Dysphagia related to neurological deficits

• Large volume of ascites

• Prior partial gastrectomy

• Long-term steroid use

Related Conditions & MeSH terms

• Gastrostomy
• Gastrostomy Complications

Intervention

Device:
• Gastropexy.
Two T-fasteners for G-tube insertion (gastropexy).

Procedure:
• Non-Gastropexy
Insertion of G-tube in absence of T-fasteners.

Locations

Country	Name	City	State
Canada	Toronto General Hospital - University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level as reported on 10-point Visual Analog Scale	10-point Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain imaginable) with specific procedure-related questions, as outlined in the pre- and post-procedure questionnaire.	Pre-procedure baseline measure, post-procedure (day 1) measure, and 30 day post-procedure measure
Secondary	Complications	Number of participants who experienced procedure-related complications (major and minor) in each arm will be assessed according to established criteria (ie SIR Adverse Event Classification).	30 days post-procedure follow-up.