Total Motorized Spiral Enteroscopy Trial

NCT ID: NCT03438695

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2019-02-28

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

Conditions

Small Bowel Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Motorized Spiral Enteroscopy

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

Group Type: EXPERIMENTAL

Motorized Spiral Enteroscopy

Intervention Type: PROCEDURE

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of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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.

Interventions

Motorized 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of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal.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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Evangelisches Krankenhaus Düsseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torsten Beyna, MD

Role: STUDY_CHAIR

EVK Düsseldorf, Germany

Central Contacts

Torsten Beyna, MD

Role: CONTACT

torsten.beyna@evk-duesseldorf.de

+49-211-9191605

Horst Neuhaus, MD, PhD

Role: CONTACT

horst.neuhaus@evk-duesseldorf.de

+49-211-9191605

References

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.

Reference Type: DERIVED

PMID: 33144239 (View on PubMed)

Other Identifiers

TMSET 1.0

Identifier Type: -

Identifier Source: org_study_id