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

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06071247
• Other study ID #: 3D-A2020005
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 7, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: October 2023
• Source: Guangdong Second Provincial General Hospital
• Contact: Xiaofeng Li
• Phone: 13560367697
• Email: GD2H_Digitallab[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Common Bile Duct Calculi
• Gallstones

Intervention

Other:
• 3D 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiawei Qin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	The operation time of the 3D printed model group was shorter than that of the control group	intraoperatively
Primary	Surgery success rate	The surgery success rate of the 3D printed model group was higher than that of the control group	intraoperatively
Primary	amount of bleeding	The amount of bleeding of the 3D printed model group was lower than that of the control group	intraoperatively
Primary	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