An Observational Study to Learn More About the Impact of Gadoxetate Sodium-Enhanced Magnetic Resonance Imaging (EOB-MRI) When Used to Diagnose the Spread of Cancer From the Pancreas to the Liver in Japanese People Under Real-World Conditions

NCT06106568 | Completed

• 1 other identifier: 22470
• Study Type: observational
• Target: 39,624
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study in which data from people with cancer that has spread from the pancreas to the liver are collected and studied. These adults will include people who already received their usual treatment and who have had a certain type of imaging scan before the diagnosis of pancreatic cancer. Metastatic pancreatic cancer is a cancer that starts in the pancreas, a gland that helps to digest food, and has spread to other parts of the body. Pancreatic cancer most commonly spreads to the liver (called liver metastasis). Gadoxetate sodium-enhanced magnetic resonance imaging (EOB-MRI) is a type of imaging technique that uses a specific dye called gadoxetate sodium to produce clearer images of the liver. Participants with pancreatic cancer can be treated with surgery only if their cancer has not spread to other parts of the body. Therefore, it is important to find out if the cancer has spread to other parts of the body before performing surgery. To do this, different imaging scans such as exploratory laparoscopy and CE-CT are used. However, these tests have certain limitations, such as complicated procedures or, in some cases inaccurate results. Some studies suggest that performing EOB-MRI along with a regular CT scan may improve the chances of finding out if pancreatic cancer has spread to the liver. This imaging technique is especially helpful in detecting smaller tumors that may be missed in other types of scan. However, more information is needed to better understand the impact of EOB-MRI in Japanese people under real-world conditions. The main purpose of this study is to learn more about how using EOB-MRI helps in deciding the treatment options, how well the participants do, and how much does the use of medical care facilities costs. The main information that researchers will collect in this study: participant characteristics, including age, sex, whether they smoke or not, how well they can manage daily tasks, any other health problems they have, how advanced their cancer is, and if they have undergone laparoscopy the length of time: from the date of diagnosis of pancreatic cancer until a participant dies (called overall survival) from the date of first treatment for pancreatic cancer until the cancer spreads of other organs from the date of diagnosis of pancreatic cancer to starting the first treatment from the date of first treatment for pancreatic cancer to starting the second treatment option treatments that the participants have received, including anti-cancer drugs, radiation, and surgery the number of hospital visits, use of healthcare facilities, and related costs. The information in this study will be grouped based on the participants who had an EOB-MRI and those who had non EOB-MRI. The data will come from the participants' information stored in a database called Medical Data Vision (MDV) in Japan. Data collected will be from January 2011 to October 2022. Researchers will track individual patients' data for at least 1 year, until death, until there is no health record in the MDV for 2 months after treatment starts, or until the end of study. In this study, only available data from health records are collected. No visits or tests are required as part of this study.

Conditions

Metastatic Pancreatic Cancer; Liver Metastases; Gadoxetate Sodium-enhanced Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group

  Up to 12 years

• Descriptive summary of treatment pathways in EOB-MRI and non-EOB-MRI group

  Up to 12 years

• Descriptive summary of healthcare utilization patterns in EOB-MRI and non-EOB-MRI group

  Up to 12 years

• Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group

  Up to 12 years

Secondary Outcomes (14)

• Descriptive summary of patient characteristics in EOB-MRI and non-EOB-MRI group within the subgroups of interest

  Up to 12 years

• Descriptive summary of clinical outcomes in EOB-MRI and non-EOB-MRI group within the subgroups of interest

  Up to 12 years

• Descriptive summary of healthcare utilization pattern in EOB-MRI and non-EOB-MRI group within the subgroups of interest

  Up to 12 years

• Descriptive summary of healthcare costs in EOB-MRI and non-EOB-MRI group within the subgroups of interest

  Up to 12 years

• Comparison of overall survival (time from pancreatic cancer diagnosis date to death) (in days) between patients in the EOB-MRI and non-EOB-MRI groups within the subgroups of interest (surgery and non-surgery)

  Up to 12 years

Study Arms (8)

EOB-MRI

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI

Procedure: EOB-MRI

non-EOB-MRI

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MBI

EOB-MRI with surgery

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and surgery

Procedure: EOB-MRI; Procedure: Surgery

non-EOB-MRI with surgery

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of surgery

Procedure: Surgery

EOB-MRI without surgery

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI but without a record of surgery

Procedure: EOB-MRI

non-EOB-MRI without surgery

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI or surgery

EOB-MRI with an open-close laparotomy

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and with a record of EOB-MRI and an open-close laparotomy

Procedure: EOB-MRI; Procedure: Open-close Laparotomy

non-EOB-MRI with an open-close laparotomy

Adult patients with confirmed diagnosis of pancreatic cancer who had the prescription record of an active treatment preceding the pancreatic cancer diagnosis and without a record of EOB-MRI but with a record of an open-close laparotomy

Procedure: Open-close Laparotomy

Interventions

EOB-MRI PROCEDURE

Retrospective analysis for pancreatic cancer patients who had a record of EOB-MRI in the Medical Data Vision (MDV) database in Japan

EOB-MRI; EOB-MRI with an open-close laparotomy; EOB-MRI with surgery; EOB-MRI without surgery

Surgery PROCEDURE

Retrospective analysis for pancreatic cancer patients who had a record of any surgery for the pancreatic cancer in the Medical Data Vision (MDV) database in Japan

EOB-MRI with surgery; non-EOB-MRI with surgery

Open-close Laparotomy PROCEDURE

Retrospective analysis for pancreatic cancer patients who had a record of an open-close laparotomy in the Medical Data Vision (MDV) database in Japan

EOB-MRI with an open-close laparotomy; non-EOB-MRI with an open-close laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective observational study utilizing data extracted from a hospital-based administrative health insurance claims database provided by Medical Data Vision Co. Ltd (MDV, Tokyo, Japan). Eligible patients are adult patients with a confirmed diagnosis of pancreatic cancer (identified by International Classification of Diseases, 10th revision \[ICD-10\] code C25.x) during the overall study period (i.e., between 01 Jan 2011 and 31 Oct 2022) .

You may qualify if:

• Patients having at least one confirmed diagnosis of pancreatic cancer (identified by ICD-10 diagnosis code C25.x, without a suspicious diagnosis flag) during the patient selection period
• Patients having at least one active treatment record after the 1st confirmed diagnosis of pancreatic cancer
• Patients 18 years of age or older at the index date
• Patients having any recorded CE-CT or EOB-MRI or MRI without EOB record during the baseline period
• EOB-MRI stands for enhanced liver MRI using gadoxetate sodium as the contrast agent. In this type of MRI, gadoxetate sodium is used as a contrast agent in the visualization of the liver tumor.
• EOB-MRI group will include patients who underwent EOB-MRI during the baseline period.
• Non-EOB-MRI group will include patients who underwent CE-CT or MRI with contrast agent other than the gadoxetate sodium during the baseline period.
• MRI, CE-CT and contrast agents are identified by using the nine-digit Japanese receipt code specified in the separate code list

You may not qualify if:

• Patients with no confirmed diagnosis of pancreatic cancer (ICD-10 diagnosis code C25.x) in the below category of the disease name in the discharge summary until the 1st discharge date after the index date:
• "ICD-10 code of disease name which input the most medical resources"
• "ICD-10 name of disease behind hospitalization"
• Patients with no active treatment within 3 months (90 days) from the con-firmed pancreatic cancer diagnosis date
• Patients with no medical record in the MDV database within 1 month (30 days) from the index date

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Japan

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 20, 2023
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)