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NCT06093009 Clinical Trial

The Significance of Postoperative Muscle Wasting in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
National Cheng Kung University Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06093009
Other study ID # B-ER-110-420
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2002
Est. completion date June 2023

Study information
Verified date October 2023
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 208
Est. completion date June 2023
Est. primary completion date April 2020
Accepts healthy volunteers
Gender All
Age group 20 Years to 120 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• pancreatectomy

Locations
Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

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