Common Bile Duct CalculiNCT06071247
Application and Translational Research of 3D Printed in Treatment of Choledocholithiasis Under ERCP
A study testing 3D printed models in people with Common Bile Duct Calculi, run by Jiawei Qin.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- 3D printed models
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Application and Translational Research of 3D Printed Models in the Surgical Treatment of Common Bile Duct Stones Under Endoscopic Retrograde Cholangiopancreatography
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.
- Conditions
- Common Bile Duct Calculi
- Being tested
- 3D printed models
- Keywords
- Common Bile Duct Calculi ;ERCP ;3D printed models
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed modelsOther
3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials
| Study group | Role | What they receive |
|---|---|---|
| Use 3D printed models group | Experimental | This group will use 3D printed models for preoperative simulation planning and then undergo surgery Receives: Other: 3D printed models |
| Not use 3D printed models group | No intervention | This group will undergo surgery directly without using 3D printed models. |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
The operation time of the 3D printed model group was shorter than that of the control group
Measured: intraoperatively
Surgery success rate
The surgery success rate of the 3D printed model group was higher than that of the control group
Measured: intraoperatively
amount of bleeding
The amount of bleeding of the 3D printed model group was lower than that of the control group
Measured: intraoperatively
complications
The complications of the 3D printed model group was lower than that of the control group
Measured: Within 3 days to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start7 Oct 2023 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Qin, Guangdong Second Provincial General Hospital
- Investigators
- Xiaofeng Li, Principal investigator, Guangdong Second Provincial General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071247
- Sponsor's protocol ID
- 3D-A2020005
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Translational Research of 3D Printed Models in the Surgical Treatment of Common Bile Duct Stones Under Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT06071247
- Acronym / sponsor ID
- 3D-A2020005
- Conditions
- Common Bile Duct Calculi
- Keywords
- Common Bile Duct Calculi ;ERCP ;3D printed models
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiawei QinUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use 3D printed models group | Experimental | Other: 3D printed modelsThis group will use 3D printed models for preoperative simulation planning and then undergo surgery |
| Not use 3D printed models group | No intervention | –This group will undergo surgery directly without using 3D printed models. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed models3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials | Other | Use 3D printed models group |
Primary outcome
operation time
Time frame: intraoperatively
The operation time of the 3D printed model group was shorter than that of the control group
Surgery success rate
Time frame: intraoperatively
The surgery success rate of the 3D printed model group was higher 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Li principal investigator
Guangdong Second Provincial General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed models in people with Common Bile Duct Calculi, run by Jiawei Qin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Li (13560367697, GD2H_Digitallab@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: intraoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.