ClinicalTrials.Veeva

Menu

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

J

Jiawei Qin

Status

Not yet enrolling

Conditions

Common Bile Duct Calculi

Treatments

Other: 3D printed models

Study type

Interventional

Funder types

Other

Identifiers

NCT06071247
3D-A2020005

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Use 3D printed models group
Experimental group
Description:
This group will use 3D printed models for preoperative simulation planning and then undergo surgery
Treatment:
Other: 3D printed models
Not use 3D printed models group
No Intervention group
Description:
This group will undergo surgery directly without using 3D printed models.

Trial contacts and locations

0

Loading...

Central trial contact

Xiaofeng Li

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems