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Multicenter study to evaluate the efficacy of the motorized spiral enteroscope in the management of small bowel diseases.
Background and Aims:
Motorized Spiral enteroscopy is a recent advancement in enteroscopy. Data are scarce on the utility and safety of the motorized spiral enteroscopy. No data is available on the utility of this technique in patients with altered gastrointestinal (GI) anatomy.
This study aimed to evaluate the efficacy of motorized spiral enteroscopy including rate of total enteroscopy (TER) in patients undergoing enteroscopy for suspected small bowel disease including those with altered GI anatomy.
Methods: A multicenter prospective study evaluated consecutive patients with symptomatic small bowel disease who underwent enteroscopy over a 12-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Motorized Spiral Enteroscopy | Procedure: Motorized Spiral Enteroscopy: PowerSpiral enteroscope will be inserted and advanced with the assistance of motorized spiral rotation, After reaching the point of maximum insertion, cecum or if no further advancement of the enteroscope can be achieved, the enteroscope will be withdrawn using motorized counter-clockwise spiral rotation. When no total enteroscopy is reached, submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde enteroscopy is then performed in the same session or at second session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motorized Spiral enteroscopy | Device | Small-bowel enteroscopy for diagnosis and intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| The diagnostic yield of motorized spiral enteroscopy | Diagnostic yield achieved by antegrade and/or retrograde enteroscopy using motorized spiral enteroscopy | 2 days |
| The therapeutic yield of motorized spiral enteroscopy | Total number of therapeutic interventions performed during antegrade and/or retrograde enteroscopy using the motorized spiral enteroscopy | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total enteroscopy rate | Estimate the number of total enteroscopy procedures achieved by either antegrade only or antegrade and retrograde motorized spiral enteroscopy | 2 days |
| Technical success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with suspected small bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small bowel imaging, or video capsule enteroscopy
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| Name | Affiliation | Role |
|---|---|---|
| A Al-Toma, Ph.D. | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University Medical Center | Amsterdam | 6813KJ | Netherlands | |||
| University Medical Centre Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35226945 | Derived | Al-Toma A, Beaumont H, Koornstra JJ, van Boeckel P, Hergelink DO, van der Kraan J, Inderson A, de Ridder R, Jacobs M. The performance and safety of motorized spiral enteroscopy, including in patients with surgically altered gastrointestinal anatomy: a multicenter prospective study. Endoscopy. 2022 Nov;54(11):1034-1042. doi: 10.1055/a-1783-4802. Epub 2022 Feb 28. |
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Estimate the rate of technically successful enteroscopy procedures both antegrade and retrograde motorized spiral enteroscopy
| 2 days |
| Total procedural time | The total time needed to complete the whole procedure of enteroscopy antegrade and/or retrograde motorized spiral enteroscopy | 2 days |
| Depth of maximum insertion into the small bowel | Estimation of the maximum depth of insertion (in centimeters) both antegrade and/or retrograde motorized spiral enteroscopy | 2 days |
| Adverse events | Total minor and also serious adverse events during and after antegrade and/or retrograde motorized spiral enteroscopy | 7 days |
| Groningen |
| 9700 RB |
| Netherlands |
| Leiden University Medical Centre | Leiden | 2311ZN | Netherlands |
| Maastricht UMC+ | Maastricht | 6202 AZ | Netherlands |
| St Antonius hospital | Utrecht | 3430 EM | Netherlands |