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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-07

Study Completion Date

2026-03-31

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.

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Detailed Description

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Conditions

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Common Bile Duct Calculi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Use 3D printed models group

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

Group Type EXPERIMENTAL

3D printed models

Intervention Type OTHER

3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials

Not use 3D printed models group

This group will undergo surgery directly without using 3D printed models.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No