GastrostomyNCT04107974
PRG With and Without Gastropexy
A study testing Gastropexy. and Non-Gastropexy in people with Gastrostomy and Gastrostomy Complications, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy, Gastrostomy Complications
- What is being tested?
- Gastropexy. and Non-Gastropexy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR contact
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR, (416) 340-4800 ext. 3250
Ganesan.Annamalai@sinaihealthsystem.ca
About this study
Official title: 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.
Read the 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
- Being tested
- Gastropexy., Non-Gastropexy
- Keywords
- Gastropexy, Percutaneous Radiologic Gastrostomy, Interventional Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastropexy.Device
Two T-fasteners for G-tube insertion (gastropexy).
Non-GastropexyProcedure or surgery
Insertion of G-tube in absence of T-fasteners.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non-Gastropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-procedure baseline measure, post-procedure (day 1) measure, and 30 day post-procedure measure
Secondary outcomes (1)
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).
Measured: 30 days post-procedure follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Apr 2019
- Primary completion11 Nov 2019 (estimated)
- Study completion11 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing gastropexy to non-gastropexy for quality of life and complications.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganesan Annamalai, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107974
- Sponsor's protocol ID
- 18-5102
- Status last verified
- Sep 2019
- First submitted
- 20 May 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single center trial. Only researchers at this site will have access to the participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Radiologic Gastrostomy With and Without Gastropexy: A Prospective Comparison
- ClinicalTrials.gov ID
- NCT04107974
- Acronym / sponsor ID
- 18-5102
- Conditions
- Gastrostomy, Gastrostomy Complications
- Keywords
- Gastropexy, Percutaneous Radiologic Gastrostomy, Interventional Radiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 11 Nov 2019 (estimated)
- Study completion
- 11 Nov 2019 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing gastropexy to non-gastropexy for quality of life and complications.
| Arm | Type | Receives |
|---|---|---|
| Gastropexy | Experimental | Device: 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. |
| Non-Gastropexy | Experimental | Procedure: Non-GastropexyPercutaneous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastropexy.Two T-fasteners for G-tube insertion (gastropexy). | Device | Gastropexy |
| Non-GastropexyInsertion of G-tube in absence of T-fasteners. | Procedure or surgery | Non-Gastropexy |
Primary outcome
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
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.
1 secondary outcome
Complications
Time frame: 30 days post-procedure follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No. This is a single center trial. Only researchers at this site will have access to the participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastropexy. and Non-Gastropexy in people with Gastrostomy and Gastrostomy Complications, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ganesan Annamalai, MB, BCh, BAO, FRCSI, FRCR (: (416) 340-4800 ext. 3250, Ganesan.Annamalai@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.