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

Navigating the Biliary Maze：a Retrospective Cohort Study of Augmented Reality Improving Outcomes in Choledochal Dilation Resection

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.

Study Overview

• Status: Recruiting
• Conditions: Choledochal Cyst; Congenital Biliary Dilatation
• Intervention / Treatment: Device: Three-dimensional visualization technology

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital
      • Contact: zeng ning, Doctor; Phone Number: +86 +8613760694012; Email: chen_ning16@foxmail.com
      • Contact: cai peilin, master; Phone Number: +86 +8615625854491; Email: v689023@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

Inclusion Criteria:

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;

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Augmented Reality Navigation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complete blood count	G/L	perioperative period
Repeat surgery rate		perioperative period
serum bilirubin levels	μmol/L	perioperative period

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Augmented reality; Congenital Biliary Dilatation; Choledochal Cyst; Digital intelligent; Three-dimensional visualization
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Congenital Abnormalities; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Dilatation, Pathologic; Choledochal Cyst
• Other Study ID Numbers: 2024-KY-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: after 2024.5.30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No