PRG With and Without Gastropexy

Percutaneous Radiologic Gastrostomy With and Without Gastropexy: A Prospective Comparison

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.

Study Overview

• Status: Unknown
• Conditions: Gastrostomy; Gastrostomy Complications
• Intervention / Treatment: Device: Gastropexy.; Procedure: Non-Gastropexy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR; Phone Number: 3250 : (416) 340-4800; Email: Ganesan.Annamalai@sinaihealthsystem.ca
• Study Contact Backup: Name: Shawn Bailey, MD, BHSc; Phone Number: 4168032521; Email: shawn.bailey@mail.utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital - University Health Network
      • Contact: Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR; Phone Number: 3250 (416) 340-4800
      • Contact: Ganesan.Annamalai@sinaihealthsystem.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gastropexy; Percutaneous radiologic guided insertion of G-tube. The skin over the epigastrium is prepared and draped in sterile fashion. Midazolam and fentanyl are administered for conscious sedation. Lidocaine for local analgesia. The stomach is insufflated with air after insertion of an OG or NG tube. Two T-fasteners are inserted into the stomach approximately 4cm apart. A needle is inserted into the stomach and an Amplatz wire is then inserted into the stomach. The tract is dilated with an 18Fr peel away sheath. A 14 Fr balloon retention gastrostomy tube is inserted. The balloon is inflated and bolster set as appropriate. The gastropexy/T-fastener sutures are cut after one week.	Device: Gastropexy.; Two T-fasteners for G-tube insertion (gastropexy).
EXPERIMENTAL: Non-Gastropexy; Percutaneous radiologic guided insertion of G-tube. The skin over the epigastrium is prepared and draped in sterile fashion. Midazolam and fentanyl are administered for conscious sedation. Lidocaine for local analgesia. The stomach is insufflated with air after insertion of an OG or NG tube. A needle is inserted into the stomach and an Amplatz wire is then inserted into the stomach. The tract is dilated with an 18Fr peel away sheath. A 14 Fr balloon retention gastrostomy tube is inserted. The balloon is inflated and bolster set as appropriate.	Procedure: Non-Gastropexy; Insertion of G-tube in absence of T-fasteners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): November 11, 2019
• Study Completion (ANTICIPATED): November 11, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (ACTUAL): September 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Interventional Radiology; Gastropexy; Percutaneous Radiologic Gastrostomy
• Other Study ID Numbers: 18-5102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a single center trial. Only researchers at this site will have access to the participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No