Application and Translational Research of 3D Printed in Treatment of Choledocholithiasis Under ERCP

Study Overview
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Brief Summary
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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.

Official Title
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Application and Translational Research of 3D Printed Models in the Surgical Treatment of Common Bile Duct Stones Under Endoscopic Retrograde Cholangiopancreatography

Conditions
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Common Bile Duct Calculi

Intervention / Treatment
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* Other: 3D printed models


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use 3D printed models group<br>This group will use 3D printed models for preoperative simulation planning and then undergo surgery | Other: 3D printed models<br>* 3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials<br>|
| No Intervention: Not use 3D printed models group<br>This group will undergo surgery directly without using 3D printed models. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | The operation time of the 3D printed model group was shorter than that of the control group | intraoperatively | 
| Surgery success rate | The surgery success rate of the 3D printed model group was higher than that of the control group | intraoperatively | 
| amount of bleeding | The amount of bleeding of the 3D printed model group was lower than that of the control group | intraoperatively | 
| complications | The complications of the 3D printed model group was lower than that of the control group | Within 3 days to 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common Bile Duct Calculi ;ERCP ;3D printed models