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

August 12, 2021 updated by: The Affiliated Hospital of Qingdao University

Systemic Immune-inflammation Index (SII) And Platelet-albumin-bilirubin (PALBI) is Associated With the Prognosis of Pancreatic Cancer Surgery

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.

Study Overview

Status

Completed

Conditions

Pancreatic Cancer

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 Type

Observational

Enrollment (Actual)

214

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

age≥18 years old

Description

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 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
The overall survival Time Frame: 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	2013.8-2019.12

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of Qingdao University

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)

August 1, 2013

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)