PRG With and Without Gastropexy

NCT ID: NCT04107974

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-11-11

Brief 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.

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.

Conditions

Gastrostomy; Gastrostomy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Gastropexy.

Intervention Type: DEVICE

Two T-fasteners for G-tube insertion (gastropexy).

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.

Group Type: EXPERIMENTAL

Non-Gastropexy

Intervention Type: PROCEDURE

Insertion of G-tube in absence of T-fasteners.

Interventions

Gastropexy.

Two T-fasteners for G-tube insertion (gastropexy).

Intervention Type: DEVICE

Non-Gastropexy

Insertion of G-tube in absence of T-fasteners.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Ganesan Annamalai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR

Role: CONTACT

Ganesan.Annamalai@sinaihealthsystem.ca

: (416) 340-4800 ext. 3250

Shawn Bailey, MD, BHSc

Role: CONTACT

shawn.bailey@mail.utoronto.ca

4168032521

Facility Contacts

Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR

Role: primary

(416) 340-4800 ext. 3250

Ganesan.Annamalai@sinaihealthsystem.ca

Role: backup

Other Identifiers

18-5102

Identifier Type: -

Identifier Source: org_study_id