PEG by Introducer Method Via EG Scan

Not Applicable

• Conditions: Aspiration; Dysphagia; Esophageal Stenosis
• Interventions: Procedure: Percutaneous Endoscopic Gastrostomy

• Registration Number: NCT02183207
• Lead Sponsor: The Catholic University of Korea

Brief Summary

Percutaneous endoscopic gastrostomy(PEG) by introducer method has been proven to be safe and easy to perform. However, it is limited by its need to be performed in an endoscopy unit. E.G. ScanTM is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. Our aim is to prove that PEG by introducer method via E.G. ScanTM is feasible and safe. This will allow PEG to be done at hospitals and medical facilities without endoscopic units.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-11
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-02
• Last Update Submitted: 2014-07-02
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08
• Primary Completion: 2015-07
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month

Exclusion Criteria

• Patients with esophageal ulcers or strictures
• Patients with prior esophageal/gastric surgery (excepting gastric wedge resection)
• Patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation
• Other patients in whom the study investigators consider unfit for inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG insertion arm via EG Scan	Percutaneous Endoscopic Gastrostomy	Percutaneous endoscopic insertion of gastrostomy via visualization through E.G. ScanTM

Primary Outcome Measures

Name	Time	Method
The success rate of PEG via introducer method by visualization through EG ScanTM	up to 1 year from PEG insertion	up to 1 year from PEG insertion or until patient death if within one year

Secondary Outcome Measures

Name	Time	Method
Complication rate	up to one year from PEG insertion	Complication rate including bleeding, infection, gastric perforation and leakage of intragastric contents

Trial Locations

Locations (1)

Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of