Small Bowel Disease
Conditions
Keywords
endoscopy, motorized spiral enteroscopy
Brief summary
Study design Prospective bicentric non-controlled clinical trial Study purpose \- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel Primary objective Rate of total enteroscopy by means of NMSE with: 1. a complete anterograde approach 2. or a combined anterograde and retrograde approach Secondary objectives * Procedural success of anterograde and retrograde approach * Procedural time (minutes) * Depth of maximum insertion (cm) * Diagnostic yield * Therapeutic yield * Adverse events
Interventions
PROCEDUREMotorized Spiral Enteroscopy
Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.
Sponsors
Université Libre de Bruxelles
Evangelisches Krankenhaus Düsseldorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with small bowel disease with an indication for a total enteroscopy, e.g.: * Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions * Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations * Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy * Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease * Large polyps (\>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome * Nonresponsive or refractory coeliac disease
Exclusion criteria
* \- Age under 18 years * Health status American Society of Anesthesists Classification (ASA) 4 * Pregnancy * Coagulopathy (INR≥2.0, Platelets \< 70/nl) * Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days * Any medical contraindication to standard enteroscopy * Presence of any intraluminal or extraluminal foreign body in the abdominal cavity * Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable) * Known or suspected bowel obstruction or stenosis or history of bowel obstruction * Known coagulation disorder * Known or suspected esophageal stricture or Schatzki ring * Known gastric or esophageal varices * Suspected perforation of the GI tract * Known or suspected colonic or ileocecal valve (ICV) stricture * Inability to tolerate sedation or general anesthesia for any reason * Inability to tolerate endotracheal intubation * Absence of a signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of total enteroscopy by Motorized Spiral Enteroscopy | 2 days | Total enteroscopy by: 1. a complete anterograde approach 2. or a combined anterograde and retrograde approach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | 2 days | of anterograde and retrograde approach |
| Depth of maximum insertion to the small bowel | 2 days | anterograde and retrograde |
| Procedural Success Rate | 2 days | of anterograde and retrograde approach |
| Therapeutic yield | 2 days | anterograde and retrograde |
| Adverse events | 3 days | anterograde and retrograde, serious adverse events |
| Diagnostic yield | 2 days | anterograde and retrograde |
Contacts
Primary ContactTorsten Beyna, MD
Backup ContactHorst Neuhaus, MD, PhD
Outcome results
None listed