Forward-viewing versus oblique-viewing echoendoscopes in transluminal drainage of pancreatic fluid collections: a multicenter, randomized, controlled trial - 02/12/11
Reprint requests: Paul Fockens, MD, PhD, Professor of Gastrointestinal Endoscopy, Department of Gastroenterology & Hepatology, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE AmsterdamRésumé |
Background |
EUS-guided drainage of pancreatic fluid collections (PFCs) is commonly performed with oblique-viewing echoendoscopes. However, accessing the PFC under an oblique angle can make drainage difficult. These difficulties might be overcome by using a forward-viewing echoendoscope.
Objective |
To compare endoscopic PFC drainage with an oblique-viewing versus a forward-viewing echoendoscope with emphasis on ease of endoscopic drainage.
Design |
Multicenter, randomized, controlled trial.
Setting |
Four tertiary-care referral centers.
Patients |
This study involved 58 patients with PFCs.
Intervention |
Patients with PFCs (≥6 cm) in whom drainage was indicated were randomized to receive EUS-guided drainage with a forward-viewing echoendoscope or an oblique-viewing echoendoscope. In cases of failed drainage, patients were crossed over to the other study arm.
Main Outcome Measurements |
Ease of EUS-guided drainage measured by procedure time. Secondary endpoints included technical success, EUS endoscope preference, clinical success, and adverse events.
Results |
Fifty-eight consecutive patients underwent randomization, of whom 52 were available for primary endpoint analysis. All 26 EUS-guided procedures done with the oblique-viewing echoendoscope and 24 of the 26 procedures done with the forward-viewing echoendoscope were technically successful. Mean (± standard deviation) procedure time was 24:55 ± 9:58 minutes in the forward-viewing echoendoscope group and 27:04 ± 9:58 minutes in the oblique-viewing echoendoscope group (P = .44). Median overall procedure ease was graded as equal (easy) in both groups. Drainage-related adverse events occurred in 2 patients (8%) in the forward-viewing echoendoscope group versus none in the oblique-viewing echoendoscope group (P = .56). Overall clinical success was achieved in 82% of patients (95% confidence interval, 69%-91%).
Limitations |
Derived main outcome parameter and highly specialized endoscopists in tertiary-care referral centers.
Conclusion |
This multicenter, randomized, controlled trial comparing the performance of oblique-viewing echoendoscopes and forward-viewing echoendoscopes in draining PFCs did not show a difference in ease of EUS-guided drainage or procedure safety and efficacy between the forward-viewing echoendoscope and the oblique-viewing echoendoscope. Clinical success was achieved in 82% of patients.
(Clinical trial registration number: NTR1572.)
Le texte complet de cet article est disponible en PDF.Abbreviations : ETN, PFC
Plan
| DISCLOSURE: The forward-viewing echoendoscope was supplied by Olympus (Olympus Medical Systems Europe, Hamburg, Germany) without restrictions. The investigators, patients, and hospitals were not paid to participate in the trial. G. Costamagna received a research grant and serves on the advisory board forOlympus. J. Bergman and P. Fockens received research support from Olympus. No other financial relationships relevant to this publication were disclosed. |
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| If you would like to chat with an author of this article, you may contact Dr Fockens at p.fockens@amc.nl. |
Vol 74 - N° 6
P. 1285-1293 - décembre 2011 Retour au numéro
Article précédent
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