- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07414004
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
February 10, 2026 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
2451
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xi'an Jiaotong University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing pancreatic surgery combined with venous resection and reconstruction.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- preoperative confirmation of distant metastasis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidences of postoperative thrombosis
Time Frame: within 30 postoperative days
|
within 30 postoperative days
|
|
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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
|
within 30 postoperative days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of postoperative pancreatic fistula
Time Frame: within 30 postoperative days
|
within 30 postoperative days
|
|
incidence of postoperative delayed gastric emptying
Time Frame: within 30 postoperative days
|
within 30 postoperative days
|
|
incidence of postoperative post-pancreatectomy hemorrhage
Time Frame: within 30 postoperative days
|
within 30 postoperative days
|
|
postoperative overall survival
Time Frame: before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
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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
|
before discharge, and at 3, 6, 12, 18, 24, 30, and 36 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
July 31, 2025
Study Registration Dates
First Submitted
February 10, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- ZXIIT2024234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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