Buried Bumper Syndrome
Conditions
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.
Interventions
DEVICEFlamingo Device
Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device
PROCEDUREStandard Therapy
Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife
Sponsors
Kliniken Ludwigsburg-Bietigheim gGmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for Removal of PEG | Assessed at day 1 (day of intervention) |
Secondary
| Measure | Time frame |
|---|---|
| Success rate | Assessed at day 1 |
| Complications | Assessed during follow-up for up to ten days |
Countries
Germany
Outcome results
None listed