PRG With and Without Gastropexy

NCT04107974 | Unknown

• 1 other identifier: 18-5102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Gastropexy; Percutaneous Radiologic Gastrostomy; Interventional Radiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications

  30 days post-procedure follow-up.

Study Arms (2)

Gastropexy

EXPERIMENTAL

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.

Non-Gastropexy

EXPERIMENTAL

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

Interventions

Gastropexy. DEVICE

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

Gastropexy

Non-Gastropexy PROCEDURE

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

Non-Gastropexy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Interventions

Gastropexy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

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

CONTACT

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

Shawn Bailey, MD, BHSc

CONTACT

4168032521; shawn.bailey@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients and interventional radiologists cannot be blinded to the procedure as the follow up and performing the procedure for gastropexy versus non-gastropexy is different.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial comparing gastropexy to non-gastropexy for quality of life and complications.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: September 27, 2019
• Study Start: April 1, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)