Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous ReconstructionNCT07414004
Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer
An observational study of Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous Reconstruction, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The prognostic differences between open and minimally invasive radical pancreatic surgery combined with venous resection and reconstruction remain controversial, and there is a lack of high-quality evidence-based medical evidence to support either approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous Reconstruction
- How many people
- 2,451 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing pancreatic surgery combined with venous resection and reconstruction.
Who may be able to join
- diagnosis of malignant pancreatic or periampullary lesions requiring surgical pancreatic resection; preoperative imaging confirming venous involvement; undergoing pancreatic resection with simultaneous venous resection and reconstruction; and availability of complete postoperative outcome data, including thrombosis and complication grading.
Who cannot join
- preoperative confirmation of distant metastasis.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer: A Multicenter Retrospective Cohort Study
The prognostic differences between open and minimally invasive radical pancreatic surgery combined with venous resection and reconstruction remain controversial, and there is a lack of high-quality evidence-based medical evidence to support either approach. Therefore, this study intends to conduct a retrospective cohort analysis, planning to enroll pancreatic cancer patients who have undergone radical pancreatic surgery (open vs. minimally invasive) combined with venous resection and reconstruction from multiple hospitals both domestically and internationally, and to collect relevant data. The primary objective is to evaluate the differences in postoperative thrombosis and the incidence of severe complications between the two groups. Furthermore, prognostic data will be collected to assess the impact of open versus minimally invasive pancreatic surgery combined with venous resection and reconstruction on both short-term and long-term all-cause mortality in pancreatic cancer patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open | The open pancreatic surgery with venous resection and reconstruction cohort | |
| MIS | The minimally invasive pancreatic surgery with venous resection and reconstruction cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidences of postoperative thrombosis
Measured: within 30 postoperative days
incidences of major complication
Postoperative complications were defined and graded according to the Clavien-Dindo (C-D) classification system ranging from Grade I (minor deviation) to Grade V (death), with C-D ≥III being considerated as major complication
Measured: within 30 postoperative days
Secondary outcomes (5)
incidence of postoperative pancreatic fistula
Measured: within 30 postoperative days
incidence of postoperative delayed gastric emptying
Measured: within 30 postoperative days
incidence of postoperative post-pancreatectomy hemorrhage
Measured: within 30 postoperative days
postoperative overall survival
Measured: before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
postoperative recurrence-free survival
Measured: before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Oct 2024
- Primary completion31 Dec 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous ReconstructionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Retrospective
- Enrolment
- 2,451 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414004
- Sponsor's protocol ID
- ZXIIT2024234
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prognosis Between Open Pancreatic Surgery With Vein Resection and Reconstruction Versus Minimally Invasive Pancreatic Surgery With Vein Resection and Reconstruction for Pancreatic Cancer: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07414004
- Acronym / sponsor ID
- ZXIIT2024234
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,451 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 17 Feb 2026 (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.
The prognostic differences between open and minimally invasive radical pancreatic surgery combined with venous resection and reconstruction remain controversial, and there is a lack of high-quality evidence-based medical evidence to support either approach. Therefore, this study intends to conduct a retrospective cohort analysis, planning to enroll pancreatic cancer patients who have undergone radical pancreatic surgery (open vs. minimally invasive) combined with venous resection and reconstruction from multiple hospitals both domestically and internationally, and to collect relevant data. The primary objective is to evaluate the differences in postoperative thrombosis and the incidence of severe complications between the two groups. Furthermore, prognostic data will be collected to assess the impact of open versus minimally invasive pancreatic surgery combined with venous resection and reconstruction on both short-term and long-term all-cause mortality in pancreatic cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open | – | –The open pancreatic surgery with venous resection and reconstruction cohort |
| MIS | – | –The minimally invasive pancreatic surgery with venous resection and reconstruction cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pancreatic surgery combined with venous resection and reconstruction.
Key inclusion criteria (1 listed)
- diagnosis of malignant pancreatic or periampullary lesions requiring surgical pancreatic resection; preoperative imaging confirming venous involvement; undergoing pancreatic resection with simultaneous venous resection and reconstruction; and availability of complete postoperative outcome data, including thrombosis and complication grading.
Key exclusion criteria (1 listed)
- preoperative confirmation of distant metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidences of postoperative thrombosis
Time frame: within 30 postoperative days
incidences of major complication
Time frame: within 30 postoperative days
Postoperative complications were defined and graded according to the Clavien-Dindo (C-D) classification system ranging from Grade I (minor deviation) to Grade V (death), with C-D ≥III being considerated as major complication
5 secondary outcomes
incidence of postoperative pancreatic fistula
Time frame: within 30 postoperative days
incidence of postoperative delayed gastric emptying
Time frame: within 30 postoperative days
incidence of postoperative post-pancreatectomy hemorrhage
Time frame: within 30 postoperative days
postoperative overall survival
Time frame: before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
postoperative recurrence-free survival
Time frame: before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Tumor Patients Who Consecutively Underwent Minimally Invasive or Open Pancreatic Surgery With Venous Reconstruction, run by First Affiliated Hospital Xi'an Jiaotong University 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: finished, as of the sponsor's last update on 17 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidences of postoperative thrombosis (time frame: within 30 postoperative days). The study lists 2 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 Feb 2026.