Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment

April 15, 2024 updated by: Jin-Young Jang, Seoul National University Hospital
  1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
  2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
  3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
  4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

264

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study retrospectively included 264 pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital in Korea. Among 264 patients, we included 113 patients with resectable and borderline resectable pancreatic ductal adenocarcinoma with venous involvement who responded to NAT and underwent curative PD.

Description

Inclusion Criteria:

  • Pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between January 2012 and December 2022 at Seoul National University Hospital

Exclusion Criteria:

  • Metastatic unresectable and locally advanced pancreatic cancer
  • Resectable pancreatic cancer without portal/superior mesenteric vein invasion
  • Cancer aggravation after neoadjuvant treatment
  • Portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment
  • Patients who underwent palliative surgery
  • Non-pancreatic ductal adenocarcinoma patients
  • Patients who death within 30 days of surgery
  • Loss of follow-up patients
  • Patients who underwent resection for suspected main artery and adjacent organ invasion

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
Intervention / Treatment
Preservation of portal/superior mesenteric vein
Procedure: portal/superior vein resection
portal/superior vein resection
Resection of portal/superior mesenteric vein
Procedure: portal/superior vein resection
portal/superior vein resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year overall survival
Time Frame: assessed up to 60months
from diagnosis to any cause of death
assessed up to 60months
5-year portal/superior mesenteric vein stenosis free survival
Time Frame: assessed up to 60months
from surgery to stenosis
assessed up to 60months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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)

January 1, 2012

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2402-147-1516

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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