Small Bowel Disease
Conditions
Keywords
Motorized Spiral enteroscopy, Device-assisted 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.
Interventions
Small-bowel enteroscopy for diagnosis and intervention
Sponsors
St. Antonius Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic yield of motorized spiral enteroscopy | 2 days | Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy |
| The therapeutic yield of motorized spiral enteroscopy | 2 days | Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedural time | 2 days | The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy |
| Total enteroscopy rate | 2 days | Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy |
| Adverse events | 7 days | Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy |
| Depth of maximum insertion into the small bowel | 2 days | Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy |
| Technical success | 2 days | Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy |
Countries
Netherlands
Outcome results
None listed