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RecruitingNCT06418490DIIBDUpdated May 17, 2024

The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis

An observational study in Congenital Biliary Dilatation and Choledochal Cyst, sponsored by Zhujiang Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-17.

Sponsored by Zhujiang Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Choledochal cysts (CC) have traditionally been considered as cystic dilatations of the extrahepatic bile duct. Choledochal cysts are now referred to as choledochal dilatation, which also includes intrahepatic and extrahepatic cysts. Choledochal cysts are defined as cystic dilatations involving the bile duct tree of single or multiple segments of the intrahepatic and extrahepatic bile ducts. In 1959, Alonso-Lej et al. first divided CC into 3 types based on the location of bile duct dilatation. It was not until 1977 that Todani et al. revised the classification, adding 2 more types of CCs, which is the most commonly used classification by clinicians today; however, some experts dispute this, claiming that each type of CC has its own natural history, complications, and treatments. It is suggested to focus more on the pathogenesis rather than a simple anatomical classification of the bile duct tree. Choledochal cysts are a rare anomaly and are sometimes considered as a precancerous condition, which often leads to diagnostic challenges. The typical presentation of this condition is nonspecific. Medical teams must have a high clinical suspicion of choledochal cysts when investigating patients with jaundice, abdominal pain, and palpable abdominal masses. Due to the ambiguity of these symptoms and physical examination findings, appropriate imaging studies are crucial for diagnosis. Resection of choledochal dilatation has shown excellent results, with a complication-free rate of 89% and an overall 5-year survival rate exceeding 90%. Therefore, early diagnosis and appropriate management are essential to achieve optimal outcomes and a good prognosis.

Clinical practice has confirmed that the modern digital imaging technology, such as three-dimensional visualization and augmented reality navigation technology, built for hepatobiliary surgery diagnosis and treatment platform plays a crucial guiding role in precise preoperative assessment, lesion localization, formulation of optimal surgical plans, and intraoperative navigation to avoid collateral damage. Professor Fang Chihua's team has conducted long-term research and breakthroughs in this field. A significant portion of the literature in the field of digital intelligent diagnosis and treatment technology retrieved from SinoMed - China Biomedical Literature Service System comes from Professor Fang Chihua's team. The team has published consecutive expert consensus in the Chinese Journal of Practical Surgery in the field of digital intelligence in hepatobiliary surgery, including the publication of "Expert Consensus on Precise Diagnosis and Treatment of Three-Dimensional Visualization of Hepatobiliary Stones (2019 Edition)," which affirms the significant impact of three-dimensional visualization technology in guiding the precise diagnosis and treatment of hepatobiliary stones. The "Consensus recommendations of three-dimensional visualization for diagnosis and management of liver disease" published in an international journal demonstrates that China's research level in this field is at the forefront globally. Sioh Huang Lim et al. utilized ICG intraoperative navigation technology to visualize the extrahepatic bile ducts without radiation, enabling quicker identification of bile ducts compared to cholangiography. Liu Yangsui et al. applied fluorescence imaging technology for real-time navigation of the extrahepatic bile ducts, achieving superior outcomes in terms of surgical time, intraoperative blood loss, and postoperative hospital stay compared to the traditional surgery group. In laparoscopic re-exploration of the bile duct, Tian Guangjin et al. used ICG fluorescence navigation technology as surgical assistance, with a conversion to open surgery rate of approximately 3.3% in the navigation group compared to 22.9% in the conventional surgery group, achieving higher rates of minimally invasive abdominal surgery in the navigation group. Takeshi Aoki et al. indicated in their literature the successful staining of subsegments or liver segments in 33 out of 35 cases (94.3%) using fluorescence imaging technology for liver resection navigation. Kunshan He et al. demonstrated that near-infrared (NIR) imaging method resulted in less blood loss and shorter hospital stay compared to traditional methods. ICG fluorescence imaging technology has shown promising prospects in partial liver resection surgery. In conclusion, three-dimensional visualization technology can achieve precise preoperative differentiation of vascular variations, formulate individualized surgical plans based on reconstructed three-dimensional models, and provide real-time navigation during surgery to ensure the success of the operation. Intraoperative real-time augmented reality technology navigation helps prevent intraoperative bile duct injuries, effectively reduce severe postoperative complications, and decrease residual cysts and associated complications. Therefore, the combined application of both technologies in the treatment of choledochal cysts surgery provides better medical technological support, enhances surgical safety and precision, promotes the development of minimally invasive surgery, and holds significant clinical value.

02

Conditions studied

  • Congenital Biliary Dilatation
  • Choledochal Cyst

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Keywords

  • Congenital Biliary Dilatation
  • Choledochal Cyst
  • Augmented reality
  • Digital intelligent
  • Three-dimensional visualization
03

In context

Choledochal Cyst

22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.

This study's planned enrollment of 100 is below the median of 400 across 14 observational studies indexed under Choledochal Cyst.

Browse Choledochal Cyst studies →

Lead sponsor

Zhujiang Hospital is the lead sponsor of 202 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceThree-dimensional visualization technology

    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

06

What researchers measure

Primary outcomes

  1. CCI

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

    Time frame: Postoperative review lasted until 1 year

  2. operation time

    minutes

    Time frame: perioperative period

  3. intraoperative blood loss

    ml

    Time frame: perioperative period

Secondary outcomes

  1. Postoperative complete blood count

    G/L

    Time frame: perioperative period

  2. Repeat surgery rate

    Time frame: perioperative period

  3. serum bilirubin levels

    μmol/L

    Time frame: perioperative period

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Time frame: after 2024.5.30

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2024; primary completion for Sep 2024, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
May 17, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Sep 1, 2024
CompletionEst.
Feb 28, 2025
Last update
May 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06418490
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
May 17, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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