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Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children

NCT ID: NCT01920438

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Two Interventions (PEG and RIG) Compared Against Each Other

Keywords

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Percutaneous endoscopic gastrostomy, Radiologically inserted gastrostomy, Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PEG

Percutaneous Endoscopic Gastrostomy

Group Type EXPERIMENTAL

Percutaneous Endoscopic Gastrostomy

Intervention Type PROCEDURE

PEG

RIG

Radiologically-guided Insertion of Gastrostomy

Group Type EXPERIMENTAL

Radiologically-guided insertion of Gastrostomy

Intervention Type PROCEDURE

RIG

Interventions

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Percutaneous Endoscopic Gastrostomy

PEG

Intervention Type PROCEDURE

Radiologically-guided insertion of Gastrostomy

RIG

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_CHAIR

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

Locations

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Great Ormond Street Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Rashmi R Singh, MBBS, MRCS

Role: CONTACT

Phone: 02079052682

Email: [email protected]

Facility Contacts

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Rashmi R Singh, MBBS, MRCS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 20620311 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28940403 (View on PubMed)

Other Identifiers

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10SG14

Identifier Type: -

Identifier Source: org_study_id