TY - JOUR
T1 - Motorized spiral enteroscopy
T2 - Results of an international multicenter prospective observational clinical study in patients with normal and altered gastrointestinal anatomy
AU - Beyna, Torsten
AU - Moreels, Tom
AU - Arvanitakis, Marianna
AU - Pioche, Mathieu
AU - Saurin, Jean Christophe
AU - May, Andrea
AU - Knabe, Mate
AU - Agnholt, Jørgen Steen
AU - Bjerregaard, Niels Christian
AU - Puustinen, Lauri
AU - Schlag, Christoph
AU - Aabakken, Lars
AU - Paulsen, Vemund
AU - Schneider, Markus
AU - Neurath, Markus F.
AU - Rath, Timo
AU - Devière, Jacques
AU - Neuhaus, Horst
PY - 2022/8/21
Y1 - 2022/8/21
N2 - 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. Methodsâ 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. Resultsâ 298 patients (120 women; median age 68, range 19-92) were enrolled. In the post-Training phase, 21.5â Š% (nâ Š=â Š54) had previous abdominal surgery, 10.0â Š% (nâ Š=â Š25) had surgically altered anatomy. Overall, SAEs occurred in 2.3â Š% (7/298; 95â Š%CI 0.9â Š%-4.8â Š%). The SAE rate was 2.0â Š% (5/251) in the core group and 4.3â Š% (2/47) in the training group, and was not increased after abdominal surgery (1.9â Š%). Total enteroscopy was achieved in half of the patients (nâ Š=â Š42) undergoing planned total enteroscopy. In 295/337 procedures (87.5â Š%), the anatomical region of interest could be reached. Conclusionsâ 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.
AB - 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. Methodsâ 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. Resultsâ 298 patients (120 women; median age 68, range 19-92) were enrolled. In the post-Training phase, 21.5â Š% (nâ Š=â Š54) had previous abdominal surgery, 10.0â Š% (nâ Š=â Š25) had surgically altered anatomy. Overall, SAEs occurred in 2.3â Š% (7/298; 95â Š%CI 0.9â Š%-4.8â Š%). The SAE rate was 2.0â Š% (5/251) in the core group and 4.3â Š% (2/47) in the training group, and was not increased after abdominal surgery (1.9â Š%). Total enteroscopy was achieved in half of the patients (nâ Š=â Š42) undergoing planned total enteroscopy. In 295/337 procedures (87.5â Š%), the anatomical region of interest could be reached. Conclusionsâ 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.
UR - http://www.scopus.com/inward/record.url?scp=85134041656&partnerID=8YFLogxK
U2 - 10.1055/a-1831-6215
DO - 10.1055/a-1831-6215
M3 - Journal article
C2 - 35451040
AN - SCOPUS:85134041656
SN - 0013-726X
VL - 54
SP - 1147
EP - 1155
JO - Endoscopy
JF - Endoscopy
IS - 12
ER -