Total Motorized Spiral Enteroscopy Trial

Not Applicable

• Conditions: Small Bowel Disease

• Registration Number: NCT03438695
• Lead Sponsor: Evangelisches Krankenhaus Düsseldorf

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Last Update Submitted: 2018-02-13
• Study First Posted: 2018-02-20
• Last Update Posted: 2018-02-20
• Study Start: 2018-02-21
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Procedural Success Rate	2 days	of anterograde and retrograde approach
Procedural time	2 days	of anterograde and retrograde approach
Depth of maximum insertion to the small bowel	2 days	anterograde and retrograde
Diagnostic yield	2 days	anterograde and retrograde
Therapeutic yield	2 days	anterograde and retrograde
Adverse events	3 days	anterograde and retrograde, serious adverse events