SII And PALBI is Associated With the Prognosis of Pancreatic Cancer Surgery(SII,PALBI)

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT05012540
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

Chronic inflammation and immune dysfunction play a key role in the development of tumors. The aim of the study is to investigate the predictive value of SII and PALBI grade for the patients with pancreatic cancer surgery.

Detailed Description

The systemic immune-inflammation index(SII), based on the counts of platelets, neutrophils, and lymphocytes,was first found to be related to the prognosis of patients in melanoma12, and was subsequently confirmed in malignant tumors such as hepatocellular carcinoma13,and lung cancer12. A retrospective multicenter cohort study showed that bilirubin levels can interfere some inflammation index'prognosis of PDAC7.The platelet-albumin-bilirubin (platelet-albumin-bilirubin, PALBI) grade as a prognostic indicator of inflammation has been found in recent years, and its role has been confirmed in patients with liver cirrhosis14,15 and hepatocellular carcinoma 16, but there is no research to verify its role in patients with pancreatic cancer. This study aims to verify the predictive value of systemic immune inflammation index (SII) and platelet-albumin-bilirubin grade (PALBI) for the prognosis of patients with pancreatic cancer surgery, and to explore the significance of other inflammatory indicators in the overall survival(OS) and disease-free survival (DFS).

Study Timeline

• Study Start: 2013-08-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2021-07-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

Age ≥ 18 years old; It was diagnosed as pancreatic cancer by clinical manifestations, laboratory examination indexes, and pathology, and then surgically removed; Agree to participate in this study and sign an informed consent form;

Exclusion Criteria

All kinds of acute or chronic inflammation, infectious diseases and blood system diseases; Metastasis of tumors in other parts; Benign pancreatic diseases such as chronic pancreatitis and autoimmune pancreatitis; Periampullary tumors without pancreatic cancer; Suspicious pancreatic cancer patients who cannot be diagnosed; Refuse to follow up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The overall survival	2013.8-2019.12	The overall survival（OS）was defined as time between primary surgery and the patients' death. Death from other cause than PDAC or survival until the end of the observation period was considered as censored observations