Laparoscopic PancreaticoduodenectomyNCT06172062
Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy
An observational study of Laparoscopic Pancreaticoduodenectomy, run by Xinrui Zhu，MD at 1 site in China.
Trial summary
Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Pancreaticoduodenectomy
- What is being tested?
- laparoscopic pancreaticoduodenectomy
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2023to 30 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients underwent laparoscopic pancreaticoduodenectomy for benign and malignant diseases. Besides, the surgical videos had been recorded.
Who may be able to join
- 1. surgical videos that recorded complete laparoscopic pancreaticoduodenectomy including resection and reconstruction phases.
Who cannot join
- 1.surgical videos that recorded laparoscopic pancreaticoduodenectomy combined with resection and reconstruction of mesentericoportal vein.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
He Cai, MD., +862862539242, 813021545@qq.com
About this study
Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding in this surgery. Then, we will test the performance capability of the algorithm.
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Being tested
- laparoscopic pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, surgical videos, artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pancreaticoduodenectomyOther
we recorded the surgical videos of laparoscopic pancreaticoduodenectomy, and labeled the information in the video to build and test the algorithms.
| Study group | Role | What they receive |
|---|---|---|
| LPD cohort | surgical videos of laparoscopic pancreaticoduodenectomy with label to build and test the algorithms. Receives: Other: laparoscopic pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance of artifical intelligence algorithm
test the performance of the algorithm , including accuracy
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start20 Jul 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic PancreaticoduodenectomyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinrui Zhu，MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinrui Zhu，MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172062
- Sponsor's protocol ID
- 2023-1663-2
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06172062
- Acronym / sponsor ID
- 2023-1663-2
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, surgical videos, artificial intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinrui Zhu，MDUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding in this surgery. Then, we will test the performance capability of the algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPD cohort | – | Other: laparoscopic pancreaticoduodenectomysurgical videos of laparoscopic pancreaticoduodenectomy with label to build and test the algorithms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients underwent laparoscopic pancreaticoduodenectomy for benign and malignant diseases. Besides, the surgical videos had been recorded.
Key inclusion criteria (1 listed)
- 1. surgical videos that recorded complete laparoscopic pancreaticoduodenectomy including resection and reconstruction phases.
Key exclusion criteria (1 listed)
- 1.surgical videos that recorded laparoscopic pancreaticoduodenectomy combined with resection and reconstruction of mesentericoportal vein.
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 |
|---|---|---|
| laparoscopic pancreaticoduodenectomywe recorded the surgical videos of laparoscopic pancreaticoduodenectomy, and labeled the information in the video to build and test the algorithms. | Other | LPD cohort |
Primary outcome
performance of artifical intelligence algorithm
Time frame: through study completion, an average of 1 month
test the performance of the algorithm , including accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No
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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 Laparoscopic Pancreaticoduodenectomy, run by Xinrui Zhu，MD 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 15 Dec 2023. 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?
Contact He Cai, MD. (+862862539242, 813021545@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of artifical intelligence algorithm (time frame: through study completion, an average of 1 month). 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 15 Dec 2023.