Selective Extended Dissection in Different Types of Pancreatic Head Cancer: A Retrospective Cohort Study.

February 9, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

Pancreatic ductal adenocarcinoma (PDAC) is a highly malignant tumor with relatively poor survival. Surgery is the first choice for the treatment of patients with early pancreatic cancer. However, the surgical approach and the extent of resection for patients with pancreatic cancer are controversial at present.

The investigators optimized the procedure of standard pancreaticoduodenectomy to selective extended dissection (SED), which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor. The investigators retrospectively analyzed the clinicopathological data of patients with pancreatic adenocarcinoma who underwent radical surgery in our center from 2011 to 2020. Patients who underwent standard dissection (SD) were matched 2:1 to those who underwent SED using propensity score matching (PSM). The log-rank test and cox regression model were used to analyze survival data. In addition, statistical analyses were performed for the perioperative complications, postoperative pathology and recurrence pattern.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

520

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
    • Tianjin
      • Tianjin, Tianjin, China, 30000
        • Tianjin Medical University Cancer Institute and Hospital

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery

Description

Inclusion Criteria:

- 1) Patients diagnosed as resectable pancreatic cancer were pathologically diagnosed as PDAC after surgery.

2) Patients received radical surgery (R0) and had complete photos or videos of the operation.

Exclusion Criteria:

- 1) The operation records as well as related photo or video data could not reflect the surgical approach and the extent of resection.

2) Patients with incomplete clinical, pathological, imaging and follow-up information.

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
Selective extended dissection (SED) group
Procedure: Selective extended dissection of pancreaticoduodenectomy
An optimized procedure of pancreaticoduodenectomy which is based on the extra-pancreatic nerve plexus (PLX) potentially invaded by tumor.
Standard dissection (SD) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival (DFS)
Time Frame: From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.
From the day the patient received surgery to the time the patient was diagnosed with postoperative recurrence, assessed up to 36 months.

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and 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, 2011

Primary Completion (ACTUAL)

July 1, 2022

Study Completion (ACTUAL)

December 1, 2022

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Panc-2023129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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