Double-balloon Enteroscopy
Conditions
Brief summary
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Detailed description
Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation. Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.
Interventions
OTHERPredictive model
Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Dezhou People's Hospital
Yantai Affiliated Hospital of Binzhou Medical University
Zaozhuang Municipal Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease 2. CT scan of the abdomen was performed within two weeks before enteroscopy
Exclusion criteria
1. cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion 2. poor quality of bowel preparation 3. high risk esophageal varices 4. the insertion route is not oral or anal because of changes in anatomical structure 5. unsuitable for general anesthesia 6. pregnant women 7. unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total enteroscopy rate | 8 months | Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 8 months | Positive findings included vascular malformation, ulcer, polyp, diverticulum and others. |
| Procedural time | 8 months | The total time of antegrade and retrograde insertions |
| Adverse events | 8 months | Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy. |
Countries
China
Contacts
Primary ContactXiuli Zuo
Outcome results
None listed