The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

Summary

This study compares mechanical sphincter augmentation (LINX Reflux Management System) to double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to gastroesophageal reflux disease (GERD).

Timeline

Start

2015-06

Primary completion

2017-10

Completion

2018-08

Publications

• Rogers BD, Valdovinos LR, Crowell MD, Bell R, Vela MF, Gyawali CP. Number of reflux episodes on pH-impedance monitoring associates with improved symptom outcome and treatment satisfaction in gastro-oesophageal reflux disease (GERD) patients with regurgitation. Gut. 2021 Mar;70(3):450-455. doi: 10.1136/gutjnl-2020-321395. Epub 2020 May 28.
• Bell R, Lipham J, Louie BE, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1736-1743.e2. doi: 10.1016/j.cgh.2019.08.056. Epub 2019 Sep 10.
• Bell R, Lipham J, Louie B, Williams V, Luketich J, Hill M, Richards W, Dunst C, Lister D, McDowell-Jacobs L, Reardon P, Woods K, Gould J, Buckley FP 3rd, Kothari S, Khaitan L, Smith CD, Park A, Smith C, Jacobsen G, Abbas G, Katz P. Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial. Gastrointest Endosc. 2019 Jan;89(1):14-22.e1. doi: 10.1016/j.gie.2018.07.007. Epub 2018 Jul 18.

Drugs

Indications