PowerSpiral Enteroscopy Performance and Safety

St. Antonius Hospital

Status: Completed

Conditions: Small Bowel Disease

Treatments: Device: Motorized Spiral enteroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04884113

W20.204

Details and patient eligibility

About

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

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 1 patient group

Experimental: Motorized Spiral Enteroscopy

Description:

Procedure: Motorized Spiral Enteroscopy: PowerSpiral enteroscope will be inserted and advanced with the assistance of motorized spiral rotation, After reaching the point of maximum insertion, cecum or if no further advancement of the enteroscope can be achieved, the enteroscope will be withdrawn using motorized counter-clockwise spiral rotation. When no total enteroscopy is reached, submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde enteroscopy is then performed in the same session or at second session

Treatment:

Device: Motorized Spiral enteroscopy