Two Interventions (PEG and RIG) Compared Against Each OtherPEG Vs RIGNCT01920438
Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children
A study testing Percutaneous Endoscopic Gastrostomy and Radiologically-guided insertion of Gastrostomy in people with Two Interventions (PEG and RIG) Compared Against Each Other, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Two Interventions (PEG and RIG) Compared Against Each Other
- What is being tested?
- Percutaneous Endoscopic Gastrostomy and Radiologically-guided insertion of Gastrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2011to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any child referred for gastrostomy insertion
Who cannot join
- the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
- previous gastrostomy or fundoplication
- previous extensive abdominal surgery
- the child requires a concomitant major procedure on the gut or other intra- abdominal organs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital
London, WC1N 3JH
Rashmi R Singh, MBBS, MRCS, +44 2079052682, rashmi.singh@ucl.ac.uk
Joe I Curry, FRCS(Eng),FRCS(Paed Surg)
About this study
Official title: PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques.
We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity.
A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.
- Being tested
- Percutaneous Endoscopic Gastrostomy, Radiologically-guided insertion of Gastrostomy
- Keywords
- Percutaneous endoscopic gastrostomy,, Radiologically inserted gastrostomy,, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Endoscopic GastrostomyProcedure or surgery
PEG
Radiologically-guided insertion of GastrostomyProcedure or surgery
RIG
| Study group | Role | What they receive |
|---|---|---|
| PEG | Experimental | Percutaneous Endoscopic Gastrostomy Receives: Procedure: Percutaneous Endoscopic Gastrostomy |
| RIG | Experimental | Radiologically-guided Insertion of Gastrostomy Receives: Procedure: Radiologically-guided insertion of Gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
The primary end point of the study will be the total number of complications (major and minor).
Measured: 3 years
Secondary outcomes (8)
1. major complication rate : complications requiring surgery
Colonic injury or gastro-colic fistula or other visceral injury, peritonitis requiring surgery, intestinal obstruction requiring surgery, major gastrointestinal bleed, other complications requiring surgery
Measured: 3 years
2. minor complication rate : complications not requiring surgery
Infection requiring systemic antibiotics, delay more than 48 hours in establishing feeds, granulation, wound site discharge, tube-related problems (migration, dislodgement, leakage, breakage), other minor
Measured: 3 years
3.complication score
This is a score devised with weighting assigned to each complication depending on the severity of the complication.The score was devised in a consensus meeting attended by experts in the field (paediatric surgeons, interventional radiologists, junior doctors and nurses.
Measured: 3 years
4.technical failure
These are the number of PEG or RIG that are unsuccessful and require conversion to open surgical gastrostomy or laparoscopic gastrostomy.
Measured: 3 yaers
5.difficulty of procedure
Assessed by the operator as : 1) easy, 2) slightly difficult (but does not warrant conversion), 3) difficult (warrants conversion)
Measured: 3 years
6.cost of hospital treatment
Measured: 3 years
7.mortality
Measured: 3 years
8.cause of death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startDec 2011
- Primary completionAug 2014 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Two Interventions (PEG and RIG) Compared Against Each OtherStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg), Study chair, Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920438
- Sponsor's protocol ID
- 10SG14
- Acronym
- PEG Vs RIG
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nah SA, Narayanaswamy B, Eaton S, Coppi PD, Kiely EM, Curry JI, Drake DP, Barnacle AM, Roebuck DJ, Pierro A. Gastrostomy insertion in children: percutaneous endoscopic or percutaneous image-guided? J Pediatr Surg. 2010 Jun;45(6):1153-8. doi: 10.1016/j.jpedsurg.2010.02.081.
PubMed 20620311Singh RR, Nah SA, Roebuck DJ, Eaton S, Pierro A, Curry JI; PEG-RIG trial collaborators. Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy in children. Br J Surg. 2017 Nov;104(12):1620-1627. doi: 10.1002/bjs.10687. Epub 2017 Sep 20.
PubMed 28940403
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
- ClinicalTrials.gov ID
- NCT01920438
- Acronym / sponsor ID
- PEG Vs RIG / 10SG14
- Keywords
- Percutaneous endoscopic gastrostomy,, Radiologically inserted gastrostomy,, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 Aug 2013 (estimated)
- 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.
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It is a device frequently used in children that have feeding difficulties or are unable to maintain normal growth via oral feeds. The same device may be inserted in two ways: the percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray imaging. Both methods of insertion have been used in children for more than 20 years, but it is not clear which is the best method. Both methods are associated with complications, including injury to other abdominal organs and leakage leading to sepsis. There are no randomised controlled trials comparing the two techniques.
We aim to compare the outcome of both methods of gastrostomy insertion in children, with emphasis on the complication rates. We have devised a complication score with weightage assigned to each complication according to its severity.
A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per group. The primary outcome will be the overall total complication rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG | Experimental | Procedure: Percutaneous Endoscopic GastrostomyPercutaneous Endoscopic Gastrostomy |
| RIG | Experimental | Procedure: Radiologically-guided insertion of GastrostomyRadiologically-guided Insertion of Gastrostomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any child referred for gastrostomy insertion
Key exclusion criteria (4 listed)
- the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
- previous gastrostomy or fundoplication
- previous extensive abdominal surgery
- the child requires a concomitant major procedure on the gut or other intra- abdominal organs
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 |
|---|---|---|
| Percutaneous Endoscopic GastrostomyPEG | Procedure or surgery | PEG |
| Radiologically-guided insertion of GastrostomyRIG | Procedure or surgery | RIG |
Primary outcome
Complication rate
Time frame: 3 years
The primary end point of the study will be the total number of complications (major and minor).
8 secondary outcomes
1. major complication rate : complications requiring surgery
Time frame: 3 years
2. minor complication rate : complications not requiring surgery
Time frame: 3 years
3.complication score
Time frame: 3 years
4.technical failure
Time frame: 3 yaers
5.difficulty of procedure
Time frame: 3 years
6.cost of hospital treatment
Time frame: 3 years
7.mortality
Time frame: 3 years
8.cause of death
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Background: PubMed 20620311Nah SA, Narayanaswamy B, Eaton S, Coppi PD, Kiely EM, Curry JI, Drake DP, Barnacle AM, Roebuck DJ, Pierro A. Gastrostomy insertion in children: percutaneous endoscopic or percutaneous image-guided? J Pediatr Surg. 2010 Jun;45(6):1153-8. doi: 10.1016/j.jpedsurg.2010.02.081.
- Derived from this study: PubMed 28940403Singh RR, Nah SA, Roebuck DJ, Eaton S, Pierro A, Curry JI; PEG-RIG trial collaborators. Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy in children. Br J Surg. 2017 Nov;104(12):1620-1627. doi: 10.1002/bjs.10687. Epub 2017 Sep 20.
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.
Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg) study chair
Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Endoscopic Gastrostomy and Radiologically-guided insertion of Gastrostomy in people with Two Interventions (PEG and RIG) Compared Against Each Other, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 4 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 12 Aug 2013. 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 United Kingdom. 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 Rashmi R Singh, MBBS, MRCS (02079052682, rashmi.singh@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920438, which also lists 2 linked publications.
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 12 Aug 2013.