Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060781) titled 'Phase II Trial: Evaluation of the Clinical Utility of Peritoneal Lavage Cytology Using EUS-FNA in Pancreatic Cancer without Apparent Peritoneal Dissemination on Imaging' on Feb. 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Aichi Cancer Center

Condition: Condition - Pancreatic cancer patients without imaging evidence of peritoneal metastasis Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Pancreatic cancer may be accompanied by occult peritoneal dissemination that cannot be detected by imaging, regardless of resectability status or the presence of other distant metastases. This risk is considered to be higher in patients with elevated tumor markers.

This study targets patients with pancreatic cancer who have no apparent peritoneal dissemination on imaging. In these patients, peritoneal lavage cytology using EUS-FNA will be performed to determine the positivity rate of occult peritoneal dissemination, with the aim of contributing to more accurate staging and the selection of optimal treatment strategies for individual patients. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Lavage cytology using EUS-FNA

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged greater than or equal to 20 years at the time of informed consent. 2. Patients who have provided written informed consent. 3. Patients with an ECOG Performance Status of 0 or 1. 4. Patients diagnosed with pancreatic cancer without apparent peritoneal dissemination on imaging, regardless of the presence of distant metastases other than peritoneal dissemination, provided that conversion surgery may be considered. 5. Patients considered eligible for safe performance of EUS-FNA. Key exclusion criteria - 1. Patients with another active malignancy under treatment. 2. Patients with moderate or greater ascites or detectable peritoneal nodules. 3. Patients with a history of upper gastrointestinal surgery. 4. Patients considered inappropriate for this study at the discretion of the treating physician. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 20 Day Date of IRB - 2026 Year 02 Month 20 Day Anticipated trial start date - 2026 Year 03 Month 03 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069540

Disclaimer: Curated by HT Syndication.