Clinical trial NCT01920438: Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children
Official title: PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Two Interventions (PEG and RIG) Compared Against Each Other
Keywords: Percutaneous endoscopic gastrostomy,
Radiologically inserted gastrostomy,
Complications
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* any child referred for gastrostomy insertion

Exclusion Criteria:

* 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

Primary outcomes:
measure: Complication rate
timeFrame: 3 years
Secondary outcomes:
measure: 1. major complication rate : complications requiring surgery
timeFrame: 3 years
measure: 2. minor complication rate : complications not requiring surgery
timeFrame: 3 years
measure: 3.complication score
timeFrame: 3 years
measure: 4.technical failure
timeFrame: 3 yaers
measure: 5.difficulty of procedure
timeFrame: 3 years
measure: 6.cost of hospital treatment
timeFrame: 3 years
measure: 7.mortality
timeFrame: 3 years
measure: 8.cause of death
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon
name: Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg)
role: STUDY_CHAIR
References:
citation: 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.
citation: Singh 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.