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Clinical Trials/NCT06071247
NCT06071247
Not yet recruiting
Not Applicable

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

Jiawei Qin0 sites60 target enrollmentOctober 7, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Common Bile Duct Calculi
Sponsor
Jiawei Qin
Enrollment
60
Primary Endpoint
Surgery success rate
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2023
End Date
March 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jiawei Qin
Responsible Party
Sponsor Investigator
Principal Investigator

Jiawei Qin

Resident physician

Guangdong Second Provincial General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Surgery success rate

Time Frame: intraoperatively

The surgery success rate of the 3D printed model group was higher than that of the control group

operation time

Time Frame: intraoperatively

The operation time of the 3D printed model group was shorter than that of the control group

amount of bleeding

Time Frame: intraoperatively

The amount of bleeding of the 3D printed model group was lower than that of the control group

complications

Time Frame: Within 3 days to 1 month after surgery

The complications of the 3D printed model group was lower than that of the control group

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