Prospective, Randomized Controlled Trial Comparing a Novel and Dedicated Device to Conventional Endoscopic Techniques for the Treatment of Buried Bumper Syndrome.

BACKGROUND AND AIMS: Buried bumper syndrome (BBS) is a rare complication of percutaneous endoscopic gastrostomy (PEG) tubes. This study compared the newly developed Flamingo device with conventional endoscopic techniques for BBS treatment.

METHODS: This prospective, randomized controlled trial compared the Flamingo set (study group) with other endoscopic techniques (control group) for BBS treatment in nine German hospitals. The primary endpoint was procedure time. Further outcome parameters were technical success, adverse event rate, and number and cost of devices used in each group.

RESULTS: Thirty-six patients (18 in each group; mean age, 73 years; 12 females) were included in this study between March 2018 and December 2022. Median time since the placement of the feeding tube was 30 months. The bumper was located in the gastric corpus in 27 patients, and the internal bumper was completely overgrown in 31 patients. The removal procedure duration was 17 min (range: 3-72 min) in the study group compared to 38 min (range: 12-111 min) in the control group (P = .046). Primary technical success rate was 77.8% in the study group and 55.6% in the control group (P = .157), while the overall technical success rate was 100% compared to 83.3% (P = .070). Adverse events occurred in four patients (11.1 %).

CONCLUSIONS: Endoscopic removal of the buried bumper using the Flamingo device was significantly faster than that with other endoscopic techniques and showed a higher technical success. This device may become the endoscopic treatment of choice for BBS.