Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Dezhou People's Hospital | OTHER |
| Yantai Affiliated Hospital of Binzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predictive model group | Experimental | Endoscopists will obtain the predictive model intervention. |
|
| Control group | No Intervention | Endoscopists will not obtain the predictive model intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predictive model | Other | Endoscopists obtain the patient's predictive model scores before double-balloon enteroscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | Positive findings included vascular malformation, ulcer, polyp, diverticulum and others. | 8 months |
| Procedural time | The total time of antegrade and retrograde insertions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuli Zuo | Contact | 86-0531-82165292 | xiulizuo@sdu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dezhou People's Hospital | Recruiting | Dezhou | Shandong | China | ||
| Qilu Hospital of Shandong University (Qingdao) |
Not provided
| ID | Term |
|---|---|
| D000098412 | Predictive Learning Models |
| ID | Term |
|---|---|
| D000098411 | Prediction Methods, Machine |
| D001185 | Artificial Intelligence |
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
Not provided
Not provided
| Zaozhuang Municipal Hospital |
| OTHER |
Not provided
Not provided
Not provided
Not provided
| 8 months |
| Adverse events | Adverse reactions refer to bleeding, perforation, aspiration pneumonia, acute pancreatitis and other conditions related to double-balloon enteroscopy. | 8 months |
| Recruiting |
| Qingdao |
| Shandong |
| China |
| Yantai Affiliated Hospital of Binzhou Medical University | Recruiting | Yantai | Shandong | China |
| Zaozhuang Municipal Hospital | Recruiting | Zaozhuang | Shandong | China |
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shangdong | China |