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Not yet recruitingNCT06071247Updated Oct 16, 2023

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

An interventional study of 3D printed models in Common Bile Duct Calculi, sponsored by Jiawei Qin. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Jiawei Qin · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Common Bile Duct Calculi

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Keywords

  • Common Bile Duct Calculi ;ERCP ;3D printed models
03

In context

Gallstones

199 studies on the registry are indexed under Gallstones; 35 are open to participants now.

This study's planned enrollment of 60 is below the median of 98 across 121 interventional studies indexed under Gallstones.

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Lead sponsor

This is the only study on the registry with Jiawei Qin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Use 3D printed models group

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

    Other: 3D printed models

  • No intervention
    Not use 3D printed models group

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

Interventions

  • Other3D 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

06

What researchers measure

Primary outcomes

  1. operation time

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

    Time frame: intraoperatively

  2. Surgery success rate

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

    Time frame: intraoperatively

  3. amount of bleeding

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

    Time frame: intraoperatively

  4. complications

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

    Time frame: Within 3 days to 1 month after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06071247
Lead sponsor
Jiawei Qin
Responsible party
Jiawei Qin (Resident physician, Guangdong Second Provincial General Hospital) — Sponsor-investigator
First posted
Oct 6, 2023
Start date
Oct 7, 2023 (estimated)
Primary completion
Mar 31, 2026 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Oct 16, 2023

Study contacts

Xiaofeng Li
Contact
GD2H_Digitallab@163.com
13560367697
Xiaofeng Li
principal investigator · Guangdong Second Provincial General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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