Laparoscopic PancreaticoduodenectomyNCT06128603
Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy
An observational study of Laparoscopic Pancreaticoduodenectomy, run by Xinrui Zhu，MD at 1 site in China.
Trial summary
In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Pancreaticoduodenectomy
- What is being tested?
- laparoscopic pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 25 Feb 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 periampullary benign and malignant diseases.
Who may be able to join
- the surgical video is complete including the resection and reconstruction phases
Who cannot join
- the surgical video is not complete
- the cases 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
In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Being tested
- laparoscopic pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, intraoperative bleeding, OSATS scores, short-time outcomes
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pancreaticoduodenectomyProcedure or surgery
laparoscopic pancreaticoduodenectomy was performed for periampullary benign and malignant diseases. Besides, the surgical video was recorded.
| Study group | Role | What they receive |
|---|---|---|
| LPD group | Cases who had underwent laparoscopic pancreaticoduodenectomy Receives: Procedure: laparoscopic pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative bleeding characteristics
Bleeding characteristics include cause of bleeding, site of bleeding, size of bleeding, method of hemostasis, duration of hemostasis, and outcome of hemostasis. These would be obtained by reviewing and labeling laparoscopic pancreaticoduodenectomy surgical videos.
Measured: intraoperatively
Secondary outcomes (2)
OSATS scores
Scoring laparoscopic pancreaticoduodenectomy operations using the OSATS Surgical Operative Technique Rating Scale
Measured: intraoperatively
textbook outcome
The textbook outcome was defined as the absence of all six individual outcomes: clinically relevant postoperative pancreatic fistula, post-pancreatectomy hemorrhage, bile leak, severe complications (Clavien-Dindo≥3), readmission, and mortality within 30 days postoperatively
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Oct 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion25 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT06128603
- Sponsor's protocol ID
- 2023-1663-1
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai H, Chen Z, Zhang J, Cai Y, Wu Z, Li Y, Wang K, Zhang J, Hu R, Tang M, Wu L, Cai S, Jie J, Shi R, Peng B, Wang X. Video-based characterization of intraoperative bleeding patterns and hemostasis behaviors in laparoscopic pancreaticoduodenectomy: a retrospective cohort study. Surg Endosc. 2026 Jul 30. doi: 10.1007/s00464-026-13088-7. Online ahead of print.
PubMed 42533168
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT06128603
- Acronym / sponsor ID
- 2023-1663-1
- Conditions
- Laparoscopic Pancreaticoduodenectomy
- Keywords
- laparoscopic pancreaticoduodenectomy, intraoperative bleeding, OSATS scores, short-time outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xinrui Zhu，MDUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 13 Nov 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.
In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LPD group | – | Procedure: laparoscopic pancreaticoduodenectomyCases who had underwent laparoscopic pancreaticoduodenectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients underwent laparoscopic pancreaticoduodenectomy for periampullary benign and malignant diseases.
Key inclusion criteria (1 listed)
- the surgical video is complete including the resection and reconstruction phases
Key exclusion criteria (2 listed)
- the surgical video is not complete
- the cases 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 pancreaticoduodenectomylaparoscopic pancreaticoduodenectomy was performed for periampullary benign and malignant diseases. Besides, the surgical video was recorded. | Procedure or surgery | LPD group |
Primary outcome
intraoperative bleeding characteristics
Time frame: intraoperatively
Bleeding characteristics include cause of bleeding, site of bleeding, size of bleeding, method of hemostasis, duration of hemostasis, and outcome of hemostasis. These would be obtained by reviewing and labeling laparoscopic pancreaticoduodenectomy surgical videos.
2 secondary outcomes
OSATS scores
Time frame: intraoperatively
textbook outcome
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 42533168Cai H, Chen Z, Zhang J, Cai Y, Wu Z, Li Y, Wang K, Zhang J, Hu R, Tang M, Wu L, Cai S, Jie J, Shi R, Peng B, Wang X. Video-based characterization of intraoperative bleeding patterns and hemostasis behaviors in laparoscopic pancreaticoduodenectomy: a retrospective cohort study. Surg Endosc. 2026 Jul 30. doi: 10.1007/s00464-026-13088-7. Online ahead of print.
- 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 2 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 13 Nov 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?
intraoperative bleeding characteristics (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128603, which also lists 1 linked publication.
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 13 Nov 2023.