Clinical trial NCT04884113: PowerSpiral Enteroscopy Performance and Safety
Official title: PowerSpiral Enteroscopy: Multicenter Prospective Study on Performance and Safety Including Patients With Altered Gastrointestinal Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Disease
Keywords: Motorized Spiral enteroscopy
Device-assisted enteroscopy
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy

Brief summary: Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.

Detailed description: Background and Aims:

Motorized Spiral enteroscopy is a recent advancement in enteroscopy. Data are scarce on the utility and safety of the motorized spiral enteroscopy. No data is available on the utility of this technique in patients with altered gastrointestinal (GI) anatomy.

This study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (TER) in patients undergoing enteroscopy for suspected small bowel disease including those with altered GI anatomy.

Methods: A multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and older
2. Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
3. Written informed consent

Exclusion Criteria:

1. Contraindications for endoscopy because of comorbidities
2. Unable to provide written informed consent
3. Patients with known severe gastrointestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure
4. Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion
5. Pregnant patients
6. Health status: American Society of Anesthesiologists (ASA) class \>3
7. Inability to tolerate Propofol sedation or general anesthesia for any reason

Primary outcomes:
measure: The diagnostic yield of motorized spiral enteroscopy
timeFrame: 2 days
measure: The therapeutic yield of motorized spiral enteroscopy
timeFrame: 2 days
Secondary outcomes:
measure: Total enteroscopy rate
timeFrame: 2 days
measure: Technical success
timeFrame: 2 days
measure: Total procedural time
timeFrame: 2 days
measure: Depth of maximum insertion into the small bowel
timeFrame: 2 days
measure: Adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Utrecht
country: Netherlands
facility: St Antonius hospital
Study officials:
affiliation: St. Antonius Hospital
name: A Al-Toma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Toma A, Beaumont H, Koornstra JJ, van Boeckel P, Hergelink DO, van der Kraan J, Inderson A, de Ridder R, Jacobs M. The performance and safety of motorized spiral enteroscopy, including in patients with surgically altered gastrointestinal anatomy: a multicenter prospective study. Endoscopy. 2022 Nov;54(11):1034-1042. doi: 10.1055/a-1783-4802. Epub 2022 Feb 28.