Effect of Predictive Model on Double-Balloon Enteroscopy
ConditionDouble-balloon Enteroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong University
About this trial
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
CT scan of the abdomen was performed within two weeks before enteroscopy
Disqualifiers
cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
poor quality of bowel preparation
high risk esophageal varices
the insertion route is not oral or anal because of changes in anatomical structure
Trial design
Design model
Parallel
Treatments tested in this trial
Predictive model
Other interventionEndoscopists obtain the patient's predictive model scores before double-balloon enteroscopy.
Treatment groups
338 Participants
are divided into 2 treatment groupsGroup A: Predictive model groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total enteroscopy rate
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
Time frame
8 monthsSecondary outcomes
1
Diagnostic yield
Positive findings included vascular malformation, ulcer, polyp, diverticulum and others.
Time frame
8 months2
Procedural time
The total time of antegrade and retrograde insertions
Time frame
8 months3
Adverse events
Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy.
Time frame
8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Qilu Hospital of Shandong University
Sponsor institution
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Dezhou People's Hospital
Collaborator
Yantai Affiliated Hospital of Binzhou Medical University
Collaborator
Zaozhuang Municipal Hospital
Collaborator
Source ClinicalTrials.gov