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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidences of postoperative thrombosis
Time Frame: within 30 postoperative days
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
within 30 postoperative days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital Xi'an Jiaotong University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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