G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos).

Harold Jacob, Roel M M Bogie, Chiara Notaristefano, Roman Simantov, Nathan Gluck, Eran Israeli, Trine Stigaard, Shay Matalon, Alexander Vilkin, Ariel Benson, Stine Sloth, Amit Maliar, Amir Waizbard, Daniel Teubner, Peter Thielsen, Eyal Shachar, Shmuel Rochberger, Tiberiu Hershcovici, Julie Isabelle Plougmann, Michal Braverman, Eduard Tsvang, Armita Armina Abedi, Yuri Brachman, Peter D Siersema, Ralf Kiesslich, Menachem Moshkowitz, Beni Shpak, Julia Epshtein, John Gásdal Karstensen, Arthur Hoffman, Rogier de Ridder, Pier Alberto Testoni, Sauid Ishaq, D Nageshwar Reddy, Seth A Gross, Helmut Neumann, Martin Goetz, Dov Abramowich, Haim Shirin, Meir Mizrahi, Peter Vilmann, Johannes Wilhelm Rey, Silvia Sanduleanu-Dascalescu, Edi Viale, Hrushikesh Chaudhari, Mark B Pochapin, Michael Yair, Mati Shnell, Shaul Yaari, Jakob Westergren Hendel

Journal: Gastrointestinal endoscopy 2019;89(3):545-553

PMID: 30273591

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Abstract

BACKGROUND AND AIMS

Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy still occur. An increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device includes a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope's optics, and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing the ADR.

METHODS

In this randomized, controlled, international, multicenter study (11 centers), patients (aged ≥50 years) referred to colonoscopy for screening, surveillance, or changes in bowel habits were randomized to undergo either balloon-assisted colonoscopy by using an insufflated balloon during withdrawal or standard high-definition colonoscopy. The primary endpoint was the ADR.

RESULTS

One thousand patients were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (standard colonoscopy n = 396; balloon-assisted colonoscopy n = 407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the standard colonoscopy group (28% increase; P = .0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (P = .0033) flat adenomas (P < .0001) and sessile serrated adenomas/polyps (P = .0026).

CONCLUSION

Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat, and sessile serrated adenomas/polyps when compared with standard colonoscopy. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates and consequently reducing interval cancer incidence. (Clinical trial registration number: NCT01917513.).

Address: Gastroenterology, Liver and Nutrition Institute, Assaf Harofeh Medical Center, Tzrifin, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.; Gastroenterology and Liver Institute, Laniado Hospital, Netanya, Israel.; Gastroenterology and Liver Institute, Hadassah Medical Center, Jerusalem, Israel.; Gastroenterology Unit, Department of Surgery, Copenhagen University Hospital Herlev, Herlev, Denmark.; Department of Gastroenterology and Endoscopy, Klinikum Osnabrueck, Osnabrueck, Germany.; Endoscopy Department, UMC Maastricht, Maastricht, The Netherlands.; Division of Gastroenterology & GI Endoscopy, Vita Salute San Raffaele University-Scientific Institute San Raffaele, Milan, Italy.; Department of Gastroenterology, Russells Hall Hospital, Dudley; Department of Health and Science, Birmingham City University, Birmingham, United Kingdom.; Gastroenterology Department, Asian Institute of Gastroenterology, Hyderabad, India.; Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York, NY, USA.; Department of Interdisciplinary Endoscopy, University Hospital Mainz, Mainz, Germany.; Endoscopy Department, Universitätsklinikum Tübingen, Tübingen, Germany.; Gastroenterology, Liver and Nutrition Institute, Assaf Harofeh Medical Center, Tzrifin, Israel.; Gastroenterology and Liver Institute, Hadassah Medical Center, Jerusalem, Israel; Advanced Endoscopy, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Department of Medicine, Division of Gastroenterology and Hepatology, South Alabama University, Mobile, AL, USA.; Gastroenterology and Liver Institute, Laniado Hospital, Netanya, Israel; Department of Gastroenterology and Hepatology, UMC Radboud, Nijmegen, Netherlands.; Department of Gastroenterology and Hepatology, UMC Radboud, Nijmegen, Netherlands.

DOI: 10.1016/j.gie.2018.09.028

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MeSH Terms: Adenoma, Adenomatous Polyps, Aftercare, Aged, Colonic Polyps, Colonoscopes, Colonoscopy, Colorectal Neoplasms, Early Detection of Cancer, Feces, Female, Hemoglobins, Humans, Immunochemistry, Male, Middle Aged