Clinical trial NCT03438695: Total Motorized Spiral Enteroscopy Trial
Official title: Total Motorized Spiral Enteroscopy Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Disease
Keywords: endoscopy, motorized spiral enteroscopy
Lead sponsor: Evangelisches Krankenhaus Düsseldorf
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
First posted: 2018-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Rate of total enteroscopy by Motorized Spiral Enteroscopy
timeFrame: 2 days
Secondary outcomes:
measure: Procedural Success Rate
timeFrame: 2 days
measure: Procedural time
timeFrame: 2 days
measure: Depth of maximum insertion to the small bowel
timeFrame: 2 days
measure: Diagnostic yield
timeFrame: 2 days
measure: Therapeutic yield
timeFrame: 2 days
measure: Adverse events
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: EVK Düsseldorf, Germany
name: Torsten Beyna, MD
role: STUDY_CHAIR
References:
citation: Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.