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

Not Applicable

Not yet recruiting

• Conditions: Common Bile Duct Calculi
• Interventions: Other: 3D printed models

• Registration Number: NCT06071247
• Lead Sponsor: Jiawei Qin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-06
• Study Start: 2023-10-07
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use 3D printed models group	3D printed models	This group will use 3D printed models for preoperative simulation planning and then undergo surgery

Primary Outcome Measures

Name	Time	Method
Surgery success rate	intraoperatively	The surgery success rate of the 3D printed model group was higher than that of the control group
operation time	intraoperatively	The operation time of the 3D printed model group was shorter 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