Prospective randomized controlled trial comparing a novel and dedicated device with conventional endoscopic techniques for the treatment of buried bumper syndrome (with video).
Journal
Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505
Informations de publication
Date de publication:
Jan 2024
Jan 2024
Historique:
received:
10
05
2023
revised:
27
06
2023
accepted:
28
07
2023
pubmed:
6
8
2023
medline:
6
8
2023
entrez:
5
8
2023
Statut:
ppublish
Résumé
Buried bumper syndrome (BBS) is a rare adverse event of PEG tubes. This study compared the newly developed Flamingo device (Fujifilm Medwork GmbH, Höchstadt, Germany) with conventional endoscopic techniques for BBS treatment. This prospective, randomized controlled trial compared the Flamingo set (study group) with other endoscopic techniques (control group) for BBS treatment in 6 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. Thirty-six patients (18 in each group; mean age, 73 years; 12 women) were included in this study between March 2018 and December 2022. Median time since 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 duration of the removal procedure was 17 minutes (range, 3-72) in the study group compared with 38 minutes (range, 12-111) in the control group (P = .046). The primary technical success rate was 77.8% in the study group and 55.6% in the control group (P = .157), whereas the overall technical success rate was 100% compared with 83.3% (P = .070). Adverse events occurred in 4 patients (11.1%). 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 rate. This device may become the endoscopic treatment of choice for BBS. (Clinical trial registration number: NCT03186066.).
Sections du résumé
BACKGROUND AND AIMS
OBJECTIVE
Buried bumper syndrome (BBS) is a rare adverse event of PEG tubes. This study compared the newly developed Flamingo device (Fujifilm Medwork GmbH, Höchstadt, Germany) with conventional endoscopic techniques for BBS treatment.
METHODS
METHODS
This prospective, randomized controlled trial compared the Flamingo set (study group) with other endoscopic techniques (control group) for BBS treatment in 6 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
RESULTS
Thirty-six patients (18 in each group; mean age, 73 years; 12 women) were included in this study between March 2018 and December 2022. Median time since 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 duration of the removal procedure was 17 minutes (range, 3-72) in the study group compared with 38 minutes (range, 12-111) in the control group (P = .046). The primary technical success rate was 77.8% in the study group and 55.6% in the control group (P = .157), whereas the overall technical success rate was 100% compared with 83.3% (P = .070). Adverse events occurred in 4 patients (11.1%).
CONCLUSIONS
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 rate. This device may become the endoscopic treatment of choice for BBS. (Clinical trial registration number: NCT03186066.).
Identifiants
pubmed: 37543062
pii: S0016-5107(23)02801-8
doi: 10.1016/j.gie.2023.07.048
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT03186066']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
23-30.e1Informations de copyright
Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosure The following authors received research support for this study from Fujifilm: A. Wannhoff, B. Meier, K. Caca. A Kuellmer: Lecture fees from Ovesco Endoscopy and Falk Pharma; workshop fee from Olympus Europa; consultant for KLS Martin Group. All other authors disclosed no financial relationships. The Department of Internal Medicine and Gastroenterology at Hostpital Ludwigsburg was supported by a Grant from Fujifilm Medwork.