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Motorized spiral enteroscopy: results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomyOlympus
Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03955081 Type of study: Prospective multicenter observational study
Background Motorized spiral enteroscopy (MSE) has been shown to be safe and effective for deep enteroscopy in studies performed at expert centers with limited numbers of patients without previous abdominal surgery. This study aimed to investigate the safety, efficacy, and learning curve associated with MSE in a real-life scenario, with the inclusion of patients after abdominal surgery and with altered anatomy.
Methods Patients with indications for deep enteroscopy were enrolled in a prospective observational multicenter study. The primary objective was the serious adverse event (SAE) rate; secondary objectives were the diagnostic and therapeutic yield, procedural success, time, and insertion depth. Data analysis was subdivided into training and core (post-training) study phases at centers with different levels of MSE experience.
Results 298 patients (120 women; median age 68, range 19–92) were enrolled. In the post-training phase, 21.5 % (n = 54) had previous abdominal surgery, 10.0 % (n = 25) had surgically altered anatomy. Overall, SAEs occurred in 2.3 % (7/298; 95 %CI 0.9 %–4.8 %). The SAE rate was 2.0 % (5/251) in the core group and 4.3 % (2/47) in the training group, and was not increased after abdominal surgery (1.9 %). Total enteroscopy was achieved in half of the patients (n = 42) undergoing planned total enteroscopy. In 295/337 procedures (87.5 %), the anatomical region of interest could be reached.
Conclusions This prospective multicenter study showed that MSE was feasible and safe in a large cohort of patients in a real-life setting, after a short learning curve. MSE was shown to be feasible in postsurgical patients, including those with altered anatomy, without an increase in the SAE rate.
Received: 16 October 2021
Accepted after revision: 21 April 2022
Accepted Manuscript online:
21 April 2022
Article published online:
23 June 2022
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- 1 Chauhan SS, Manfredi MA. et al. ASGE Technology Committee. Enteroscopy. Gastrointest Endosc 2015; 82: 975-990
- 2 Pennazio M, Spada C, Eliakim R. et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy 2015; 47: 352-376
- 3 Rondonotti E, Spada C, Adler S. et al. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy 2018; 50: 423-446
- 4 Yamamoto H, Ogata H, Matsumoto T. et al. Clinical Practice Guideline for Enteroscopy. Dig Endosc 2017; 29: 519-546
- 5 Schneider M, Höllerich J, Beyna T. Device-assisted enteroscopy: A review of available techniques and upcoming new technologies. World J Gastroenterol 2019; 25: 3538-3545
- 6 Baniya R, Upadhaya S, Subedi SC. et al. Balloon enteroscopy versus spiral enteroscopy for small-bowel disorders: a systematic review and meta-analysis. Gastrointest Endosc 2017; 86: 997-1005
- 7 Lenz P, Domagk D. Double- vs. single-balloon vs. spiral enteroscopy. Best Pract Res Clin Gastroenterol 2012; 26: 303-313
- 8 Lipka S, Rabbanifard R, Kumar A. et al. Single versus double balloon enteroscopy for small bowel diagnostics: a systematic review and meta-analysis. J Clin Gastroenterol 2015; 49: 177-184
- 9 Moran RA, Barola S, Law JK. et al. A randomized controlled trial comparing the depth of maximal insertion between anterograde single-balloon versus spiral enteroscopy. Clin Med Insights Gastroenterol 2018; 11: 1179552218754881
- 10 Wadhwa V, Sethi S, Tewani S. et al. A meta-analysis on efficacy and safety: single-balloon vs. double-balloon enteroscopy. Gastroenterol Rep 2015; 3: 148-155
- 11 Neuhaus H, Beyna T, Schneider M. et al. Novel motorized spiral enteroscopy: first clinical case. VideoGIE 2016; 1: 32-33
- 12 Beyna T, Arvanitakis M, Schneider M. et al. Motorised spiral enteroscopy: first prospective clinical feasibility study. Gut 2021; 70: 261-267
- 13 Beyna T, Arvanitakis M, Schneider M. et al. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc 2021; 93: 1362-1370
- 14 Spada C, McNamara D, Despott EJ. et al. Performance measures for small-bowel endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2019; 51: 574-598
- 15 Beyna T, Schneider M, Pullmann D. et al. Motorized spiral colonoscopy: a first single-center feasibility trial. Endoscopy 2018; 50: 518-523
- 16 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
- 17 Buxbaum J, Kline M, Selby R. Prospective study of therapeutic spiral enteroscopy in patients with surgically altered anatomy. Surg Endosc 2013; 27: 671-678
- 18 Beyna T, Schneider M, Höllerich J. et al. Motorized spiral enteroscopy-assisted ERCP after Roux-en-Y reconstructive surgery and bilioenteric anastomosis: first clinical case. VideoGIE 2020; 5: 311-313
- 19 Shah RJ, Smolkin M, Yen R. et al. A multicenter, U.S. experience of single-balloon, double-balloon, and rotational overtube-assisted enteroscopy ERCP in patients with surgically altered pancreaticobiliary anatomy (with video). Gastrointestinal endoscopy 2013; 77: 593-600
- 20 Skinner M, Popa D, Neumann H. et al. ERCP with the overtube-assisted enteroscopy technique: a systematic review. Endoscopy 2014; 46: 560-572
- 21 Al-Toma A, Beaumont H, Koornstra JJ. et al. Motorized spiral enteroscopy: multicenter prospective study on performance and safety including in patients with surgically-altered gastrointestinal anatomy. Endoscopy 2022; DOI: 10.1055/a-1783-4802.