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

Primary Purpose

Common Bile Duct Calculi

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3D printed models
Sponsored by
Jiawei Qin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Calculi focused on measuring Common Bile Duct Calculi ;ERCP ;3D printed models

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Use 3D printed models group

    Not use 3D printed models group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    operation time
    The operation time of the 3D printed model group was shorter than that of the control group
    Surgery success rate
    The surgery success rate of the 3D printed model group was higher than that of the control group
    amount of bleeding
    The amount of bleeding of the 3D printed model group was lower than that of the control group
    complications
    The complications of the 3D printed model group was lower than that of the control group

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Jiawei Qin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071247
    Brief Title
    Application and Translational Research of 3D Printed in Treatment of Choledocholithiasis Under ERCP
    Official Title
    Application and Translational Research of 3D Printed Models in the Surgical Treatment of Common Bile Duct Stones Under Endoscopic Retrograde Cholangiopancreatography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 7, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2026 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jiawei Qin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Bile Duct Calculi
    Keywords
    Common Bile Duct Calculi ;ERCP ;3D printed models

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Use 3D printed models group
    Arm Type
    Experimental
    Arm Description
    This group will use 3D printed models for preoperative simulation planning and then undergo surgery
    Arm Title
    Not use 3D printed models group
    Arm Type
    No Intervention
    Arm Description
    This group will undergo surgery directly without using 3D printed models.
    Intervention Type
    Other
    Intervention Name(s)
    3D printed models
    Intervention Description
    3D printed simulation models of the stomach, duodenum, common bile duct, and pancreatic duct structures using a combination of soft and hard materials
    Primary Outcome Measure Information:
    Title
    operation time
    Description
    The operation time of the 3D printed model group was shorter than that of the control group
    Time Frame
    intraoperatively
    Title
    Surgery success rate
    Description
    The surgery success rate of the 3D printed model group was higher than that of the control group
    Time Frame
    intraoperatively
    Title
    amount of bleeding
    Description
    The amount of bleeding of the 3D printed model group was lower than that of the control group
    Time Frame
    intraoperatively
    Title
    complications
    Description
    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

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaofeng Li
    Phone
    13560367697
    Email
    GD2H_Digitallab@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaofeng Li
    Organizational Affiliation
    Guangdong Second Provincial General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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