Common Bile Duct Calculi
Conditions
Keywords
Common Bile Duct Calculi ;ERCP ;3D printed models
Brief summary
The goal of this clinical trial is to learn about Application and translational research of 3D printed models in the surgical treatment of common bile duct stones under endoscopic retrograde cholangiopancreatography. The main question it aims to answer are:Compare the differences in stone removal time, surgical complications, and surgical success rate during ERCP (+EST) surgery between 30 patients who used 3D printing preoperative simulation and 30 patients who did not use it. Participating patients will be divided into two groups, one group of 30 patients will use 3D printed models for preoperative simulation planning and then undergo surgery, and the other group will undergo surgery directly without using 3D printed models.
Interventions
OTHER3D printed models
3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials
Sponsors
Jiawei Qin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with multiple or single common bile duct stones (total stone diameter ≤1.5 cm) * Patients who voluntarily participated in the study and signed the consent form
Exclusion criteria
* Patients with various underlying diseases, such as diabetes, coronary heart disease, and hypertension, that would increase the risk of surgery and affect the outcome of surgery * Patients who have had cholangiojejunostomy or Roux-en-Y anastomosis * Combined with intrahepatic bile duct stones require surgical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operation time | intraoperatively | The operation time of the 3D printed model group was shorter than that of the control group |
| Surgery success rate | intraoperatively | The surgery success rate of the 3D printed model group was higher than that of the control group |
| amount of bleeding | intraoperatively | The amount of bleeding of the 3D printed model group was lower than that of the control group |
| complications | Within 3 days to 1 month after surgery | The complications of the 3D printed model group was lower than that of the control group |
Contacts
Primary ContactXiaofeng Li
Outcome results
None listed