Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy

Not Applicable

Completed

• Conditions: Buried Bumper Syndrome
• Interventions: Procedure: Standard Therapy; Device: Flamingo Device

• Registration Number: NCT03186066
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Brief Summary

Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.

BBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.

In this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-02
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-11
• Study First Posted: 2017-06-14
• Primary Completion: 2022-09-30
• Study Completion: 2023-04-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Endoscopy proven Buried Bumper Syndrome
• PEG or Jet-PEG

Exclusion Criteria

• Major Coagulation disorder
• Percutaneous endoscopic jejunostomy or use of a ballon fixed device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	Standard Therapy	Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.
Flamingo Device	Flamingo Device	The Flamingo device is used for treatment of Buried Bumper Syndrome.

Primary Outcome Measures

Name	Time	Method
Time for Removal of PEG	Assessed at day 1 (day of intervention)

Secondary Outcome Measures

Name	Time	Method
Success rate	Assessed at day 1
Complications	Assessed during follow-up for up to ten days

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany