Congenital Biliary DilatationDIIBDNCT06418490
The Application of Digital Intelligent Diagnostic and Therapeutic Technology in Biliary Dilation Diagnosis
An observational study of Congenital Biliary Dilatation and Choledochal Cyst, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Congenital Biliary Dilatation, Choledochal Cyst
- What is being tested?
- Three-dimensional visualization technology
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 28 Feb 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- Patients with cardiopulmonary dysfunction who cannot tolerate surgery or anesthesia; Patients with malignant transformation; Lack of clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
zhujiang Hospital
Guangzhou, Guangdong, 510280
zeng ning, Doctor, +8613760694012 ext. +86, chen_ning16@foxmail.com
cai peilin, master, +8615625854491 ext. +86, v689023@163.com
About this study
Official title: 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.
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.
- Conditions
- Congenital Biliary Dilatation, Choledochal Cyst
- Being tested
- Three-dimensional visualization technology
- Keywords
- Congenital Biliary Dilatation, Choledochal Cyst, Augmented reality, Digital intelligent, Three-dimensional visualization
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional visualization technologyDevice
Also called Augmented Reality Navigation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCI
Comprehensive Complication Index:integrating all recorded complications weighted by severity in a single formula.
Measured: Postoperative review lasted until 1 year
operation time
minutes
Measured: perioperative period
intraoperative blood loss
ml
Measured: perioperative period
Secondary outcomes (3)
Postoperative complete blood count
G/L
Measured: perioperative period
Repeat surgery rate
Measured: perioperative period
serum bilirubin levels
μmol/L
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Biliary DilatationStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418490
- Sponsor's protocol ID
- 2024-KY-042
- Acronym
- DIIBD
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating the Biliary Maze:a Retrospective Cohort Study of Augmented Reality Improving Outcomes in Choledochal Dilation Resection
- ClinicalTrials.gov ID
- NCT06418490
- Acronym / sponsor ID
- DIIBD / 2024-KY-042
- Conditions
- Congenital Biliary Dilatation, Choledochal Cyst
- Keywords
- Congenital Biliary Dilatation, Choledochal Cyst, Augmented reality, Digital intelligent, Three-dimensional visualization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-group | – | Device: Three-dimensional visualization technologyAfter 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. |
| 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- Patients with cardiopulmonary dysfunction who cannot tolerate surgery or anesthesia; Patients with malignant transformation; Lack of clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional visualization technologyAlso: Augmented Reality NavigationThree-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. | Device | 3D-group |
Primary outcome
CCI
Time frame: Postoperative review lasted until 1 year
Comprehensive Complication Index:integrating all recorded complications weighted by severity in a single formula.
operation time
Time frame: perioperative period
minutes
intraoperative blood loss
Time frame: perioperative period
ml
3 secondary outcomes
Postoperative complete blood count
Time frame: perioperative period
Repeat surgery rate
Time frame: perioperative period
serum bilirubin levels
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Biliary Dilatation and Choledochal Cyst, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCI (time frame: Postoperative review lasted until 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.