The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer

Cholangiocarcinoma Clinical Trial

Official title:

The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03637569
• Other study ID #: SMC 2018-04-087-001
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Samsung Medical Center
• Contact: Jong-In Chnag, M.D.
• Phone: 82-2-3410-3409
• Email: ji.chang[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Description:

Cachexia is frequently seen in pancreatic cancer(70-80%) and associated with reduced survival, reduced treatment tolerance and reduction in QoL. In recent studies, low-normal BMI have worse outcome (overall mortality) in cardiovascular, malignant, chronic disease (So called "obesity paradox") BMI is simple method but hard to define body composition because BMI is based on only weight and height. Skinfold thickness is strongly associated with body fatness than BMI. In this study, the ivestigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care).
• Age above 18 years old

Exclusion Criteria:

• Other malignant disease
• Underlying intestinal disease that cause absorprtion disorder
• Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Gallbladder Cancer
• Gallbladder Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Measurement of triceps skinfold thickness
By using skin thickness caliper, measure triceps skinfold thickness on the half of forearm (Rt side). In every 3 weeks, triceps skinfold thickness will be measured.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The duration between diagnosis and death	through study completion, an average of 2 year