Recruiting

PRG with Gastropexy

Sponsor:

University Health Network, Toronto

Code:

NCT04107974

Conditions

Gastrostomy

Gastrostomy Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gastropexy.

Non-Gastropexy

Study Details

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.

Conditions

Gastrostomy

Gastrostomy Complications

Study ID

NCT04107974

Start date

Apr 1, 2019

Status verified date

Sep, 2019

Completion date

Nov 11, 2019

Anticipated

Primary completion date

Nov 11, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Gastropexy.

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

Non-Gastropexy

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

Primary outcome measure

  • Pain level as reported on 10-point Visual Analog Scale [ Time Frame: Pre-procedure baseline measure, post-procedure (day 1) measure, and 30 day post-procedure measure ]

Central Contacts and Locations

Central contacts

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

: (416) 340-4800Ganesan.Annamalai@sinaihealthsystem.ca

Locations

Toronto General Hospital - University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

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

(416) 340-4800

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 27, 2019

Last verified

Sep, 2019

Keywords

  • Gastropexy
  • Percutaneous Radiologic Gastrostomy
  • Interventional Radiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2019-09-27.