No registrations found.
ID
Source
Brief title
Health condition
Small-Bowel diseases requiring enteroscopy for diagnosis or interventions. The majority are vascular disease with bleeding.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study was to evaluate the efficacy in terms of diagnostic and therapeutic yield of PSE in patients undergoing enteroscopy by both antegrade and/or retrograde approaches for suspected small-bowel disease.
Secondary outcome
Secondary objectives were to evaluate the total enteroscopy rate, technical success, procedural time, depth of maximum insertion, performance in patients with altered GI anatomy and adverse events.
Background summary
PowerSpiral enteroscopy (PSE) is a recent advancement in enteroscopy. Data are scarce on the utility and safety of PSE. 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 PSE including rate of total enteroscopy in patients undergoing enteroscopy for suspected small-bowel disease including those with altered GI anatomy.
A multicenter prospective study evaluated consecutive patients with symptomatic small-bowel disease who underwent enteroscopy over a 12-month period.
Study objective
Powerspiral enteroscopy provides an effective endoscopic procedure. Total small-bowel enteroscopy can be achieved, in one or two sessions, even in the presence of altered gastro-intestinal anatomy. It provides a great reduction of the enteroscopy procedure time. For both antegrade and retrograde PSE procedures, propofol sedation is sufficient and safe.
Study design
1. inclusion in the study and providing informed consent
2. performing the procedure (60-90) min
3. Contact after 7 days for adverse events
Intervention
Performing enteroscopy using the motorized powerspiral for diagnosis and management of small bowel disease. For example, dilatations of stenosis or performing endotherapy for bleeding lesions. In addition to aquiring tissue samples for histopathology.
Abdulbaqi Al-Toma
0883205660
a.altoma@antoniusziekenhuis.nl
Abdulbaqi Al-Toma
0883205660
a.altoma@antoniusziekenhuis.nl
Inclusion criteria
1. Age above 18 years
2. Patients with suspected small-bowel pathology indicated for diagnostic and/or therapeutic enteroscopy based on clinical presentation, small-bowel imaging, or video capsule enteroscopy
3. Written informed consent
Exclusion criteria
1. Contraindications for endoscopy because of comorbidities
2. Unable to provide written informed consent
3. Patients with known severe gastro-intestinal tract inflammation, intestinal obstruction, gastroesophageal varices or eosinophilic esophagitis that preclude a safe enteroscopy procedure
4. Coagulopathy or thrombocytopenia that could not be corrected by blood product transfusion
5. Pregnant patients
6. Health status: American Society of Anesthesiologists (ASA) class >3
7. Inability to tolerate Propofol sedation or general anesthesia for any reason
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9452 |
| Other | MEC-U (Medical Reseach Ethics Committee United), date 14-09-2020 : MEC-U (Registration number W20.204) |