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

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

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

    • 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

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
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
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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