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

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Completed

Conditions: Buried Bumper Syndrome

Treatments: Device: Flamingo Device; Procedure: Standard Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03186066

ESCAPE

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.

Treatment:

Procedure: Standard Therapy

Flamingo Device

Experimental group

Description:

The Flamingo device is used for treatment of Buried Bumper Syndrome.

Treatment:

Device: Flamingo Device