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

Sponsor

Jiawei Qin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06071247

Collaborator

(none)

Enrollment

Arms

29.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Calculi	Other: 3D printed models	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 7, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
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 3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials
No Intervention: Not use 3D printed models group This group will undergo surgery directly without using 3D printed models.

Arm

Intervention/Treatment

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

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

No Intervention: Not use 3D printed models group

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

Outcome Measures

Primary Outcome Measures

operation time [intraoperatively]
The operation time of the 3D printed model group was shorter than that of the control group
Surgery success rate [intraoperatively]
The surgery success rate of the 3D printed model group was higher than that of the control group
amount of bleeding [intraoperatively]
The amount of bleeding of the 3D printed model group was lower than that of the control group
complications [Within 3 days to 1 month after surgery]
The complications of the 3D printed model group was lower than that of the control group

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with common bile duct stones (stones <1cm)
Patients who voluntarily participated in the study and signed the consent form
Patients with indications for ERCP

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Jiawei Qin

Investigators

Principal Investigator: Xiaofeng Li, Guangdong Second Provincial General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiawei Qin, Resident physician, Guangdong Second Provincial General Hospital

ClinicalTrials.gov Identifier:

NCT06071247

Other Study ID Numbers:

3D-A2020005

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jiawei Qin, Resident physician, Guangdong Second Provincial General Hospital

Common Bile Duct Calculi ;ERCP ;3D printed models

Additional relevant MeSH terms:

Gallstones

Calculi

Study Results

No Results Posted as of Oct 6, 2023