PowerSpiral Enteroscopy Performance and Safety

St. Antonius Hospital170 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

170

Conditions

Small Bowel Disease

Interventions

Motorized Spiral enteroscopyDEVICE

Small-bowel enteroscopy for diagnosis and intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

VU University Medical Center

Amsterdam, Netherlands

University Medical Centre Groningen

Groningen, Netherlands

Leiden University Medical Centre

Leiden, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Outcomes

Primary Outcomes

The diagnostic yield of motorized spiral enteroscopy

Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy

Time frame: 2 days

The therapeutic yield of motorized spiral enteroscopy

Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy

Time frame: 2 days

Secondary Outcomes

Total enteroscopy rate

Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy

Time frame: 2 days

Technical success

Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy

Time frame: 2 days

Total procedural time

The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy

Time frame: 2 days

Depth of maximum insertion into the small bowel

Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy

Time frame: 2 days

Adverse events

Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy

Time frame: 7 days

Data from ClinicalTrials.gov

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