The Significance of Postoperative Muscle Wasting in Pancreatic Cancer

October 22, 2023 updated by: National Cheng-Kung University Hospital

National Cheng Kung University Hospital

To assess the impact of preoperative sarcopenia and postoperative skeletal muscle wasting on the outcomes of patients with resectable pancreatic cancer who underwent pancreatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies have revealed that sarcopenia, defined as generalized loss of skeletal muscle mass, is a poor prognostic factor following surgery. However, research focusing on postoperative muscle wasting and its influence on the prognosis of resectable pancreatic cancer (PC) is limited. Investigators retrospectively reviewed 208 patients who underwent pancreatectomy for PC at the National Cheng Kung University Hospital (NCKUH) between June 2002 and April 2020. Clinical information regarding patient characteristics, pathological parameters, and biochemical features was collected from all patients using electronic medical records (EMRs) under an IRB-approved protocol (B-ER-110-420) at NCKUH. Preoperative psoas major area and the degree of muscle reduction at 3 months postoperatively were calculated using computed tomography to define sarcopenia and drastic muscle wasting. Patients were assigned to two groups based on sarcopenia or drastic muscle wasting, and compared for postoperative morbidity, disease free survival (DFS), and overall survival (OS).

Study Type

Observational

Enrollment (Actual)

208

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

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University 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

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

20 Years and older (Adult, Older Adult ).

Description

Inclusion Criteria:

  • Clinical diagnosis of pancreatic cancer
  • Must be able to undergo pancreatectomy
  • Must be able to undergo pre- and post-operative abdominal computed tomography scan

Exclusion Criteria:

  • Unresectable pancreatic cancer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 10 years
Overall survival was measured as the period between the date of resection and the date of the last follow-up or death.
10 years
Disease-free survival
Time Frame: 10 years
Disease-free survival was defined as the duration from resection to cancer relapse (local, peritoneal recurrence, or distal metastasis).
10 years

Collaborators and Investigators

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

Sponsor

National Cheng-Kung 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)

June 1, 2002

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-110-420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets generated and/or analyzed during the current study are not publicly available due to privacy issues.

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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