Total Motorized Spiral Enteroscopy Trial (TMSET)

Evangelisches Krankenhaus Düsseldorf

Status: Unknown

Conditions: Small Bowel Disease

Treatments: Procedure: Motorized Spiral Enteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03438695

TMSET 1.0

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Motorized Spiral Enteroscopy

Experimental group

Description:

Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy

Treatment:

Procedure: Motorized Spiral Enteroscopy