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

NCT06071247 | Not Yet Recruiting

• 1 other identifier: 3D-A2020005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Common Bile Duct Calculi

Keywords

Common Bile Duct Calculi ;ERCP ;3D printed models

Outcome Measures

Primary Outcomes (4)

• operation time

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

  intraoperatively

• Surgery success rate

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

  intraoperatively

• amount of bleeding

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

  intraoperatively

• complications

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

  Within 3 days to 1 month after surgery

Study Arms (2)

Use 3D printed models group

EXPERIMENTAL

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

Other: 3D printed models

Not use 3D printed models group

NO INTERVENTION

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

Interventions

3D printed models OTHER

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

Use 3D printed models group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiawei Qin: lead

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaofeng Li

  Guangdong Second Provincial General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Li

CONTACT

13560367697; GD2H_Digitallab@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: October 7, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 16, 2023

Record last verified: 2023-10