NCT06418490

Brief Summary

This research discusses the clinical application value of augmented reality navigation technology combined with three-dimensional visualization technology in improving surgical safety and promoting the development of precision surgery. This technology can reduce intraoperative vascular and bile duct injuries, effectively avoid serious postoperative complications, and reduce residual cysts.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

May 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 24, 2024

Last Update Submit

May 15, 2024

Conditions

Congenital Biliary DilatationCholedochal Cyst

Keywords

Congenital Biliary DilatationCholedochal CystAugmented realityDigital intelligentThree-dimensional visualization

Outcome Measures

Primary Outcomes (3)

  • CCI

    Comprehensive Complication Index:integrating all recorded complications weighted by severity in a single formula.

    Postoperative review lasted until 1 year

  • operation time

    minutes

    perioperative period

  • intraoperative blood loss

    ml

    perioperative period

Secondary Outcomes (3)

  • Postoperative complete blood count

    perioperative period

  • Repeat surgery rate

    perioperative period

  • serum bilirubin levels

    perioperative period

Study Arms (2)

3D-group

After adequate general anesthesia, the non-3D group underwent conventional choledochal cyst excision surgery, while the 3D group underwent choledochal cyst excision surgery guided by three-dimensional visualization technology or enhanced reality navigation.

Device: Three-dimensional visualization technology

Non-3D Group

After adequate general anesthesia, the non-3D group underwent conventional choledochal cyst excision surgery, while the 3D group underwent choledochal cyst excision surgery guided by three-dimensional visualization technology or enhanced reality navigation.

Interventions

Three-dimensional visualization technologyDEVICE

Three-dimensional reconstruction technology is a software that can collect CT and MRI data, perform image segmentation and three-dimensional reconstruction of the liver, gallbladder, dilated bile ducts, pancreas, venous, and arterial systems step by step. The software is called Abdominal Medical Image 3D Visualization Software (MI-3DVS, software copyright registration number: 2008SR18798).The AR-ANS (Software Copyright No.: 2018SR840555) is an intraoperative navigation system that integrates three-dimensional visualization technology.This modification provides visual guidance for surgeons when ligating or protecting critical vascular tissues during surgery.

Also known as: Augmented Reality Navigation
3D-group

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent choledochal dilation resection surgery from January 2010 to March 2023 in zhujiang hospital were included in this study and divided into the 3D group and non-3D group.

You may qualify if:

  • Diagnosis of congenital biliary dilatation confirmed; The standard of Child-Pugh classification of preoperative liver function was; class A or B; Clinical data were complete;

You may not qualify if:

  • Patients with cardiopulmonary dysfunction who cannot tolerate surgery or anesthesia; Patients with malignant transformation; Lack of clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 17, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

February 28, 2025

Last Updated

May 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share
Time Frame
after 2024.5.30

Locations

CN(1)