The Significance of Postoperative Muscle Wasting in Pancreatic Cancer

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06093009

Collaborator

(none)

208

Enrollment

Location

252

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Procedure: pancreatectomy

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

208 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

National Cheng Kung University Hospital

Actual Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 120 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT06093009

Other Study ID Numbers:

B-ER-110-420

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Oct 24, 2023