NCT01920438

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

2.7 years

First QC Date

August 2, 2013

Last Update Submit

August 9, 2013

Conditions

Two Interventions (PEG and RIG) Compared Against Each Other

Keywords

Percutaneous endoscopic gastrostomy,Radiologically inserted gastrostomy,Complications

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    The primary end point of the study will be the total number of complications (major and minor).

    3 years

Secondary Outcomes (8)

  • 1. major complication rate : complications requiring surgery

    3 years

  • 2. minor complication rate : complications not requiring surgery

    3 years

  • 3.complication score

    3 years

  • 4.technical failure

    3 yaers

  • 5.difficulty of procedure

    3 years

  • +3 more secondary outcomes

Study Arms (2)

PEG

EXPERIMENTAL

Percutaneous Endoscopic Gastrostomy

Procedure: Percutaneous Endoscopic Gastrostomy

RIG

EXPERIMENTAL

Radiologically-guided Insertion of Gastrostomy

Procedure: Radiologically-guided insertion of Gastrostomy

Interventions

Percutaneous Endoscopic GastrostomyPROCEDURE

PEG

PEG
Radiologically-guided insertion of GastrostomyPROCEDURE

RIG

RIG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • any child referred for gastrostomy insertion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 20620311BACKGROUND

  • 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.

    PMID: 28940403DERIVED

Study Officials

  • Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg)

    Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon

    STUDY CHAIR

Central Study Contacts

Rashmi R Singh, MBBS, MRCS

CONTACT

02079052682rashmi.singh@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 12, 2013

Study Start

December 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2017

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

GB(1)