Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061741) titled 'A Study of the Utility and Safety of Staging Laparoscopy Before Preoperative Chemotherapy in Patients with Pancreatic Cancer Without Distant Metastasis on Imaging' on June 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Kobe University

Condition: Condition - Pancreatic ductal adenocarcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the detection rate of occult distant metastasis and the safety of staging laparoscopy performed prior to neoadjuvant chemotherapy in patients with pancreatic cancer without radiological evidence of distant metastasis. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Staging laparoscopy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Age 18 years or more. 2.Patients with histologically confirmed pancreatic cancer or with a clinical diagnosis strongly suggestive of pancreatic cancer. 3.Patients with resectable or borderline resectable pancreatic cancer without evidence of distant metastasis on standard imaging assessments, including contrast-enhanced computed tomography (CT), magnetic resonance imaging (MRI), and/or fluorodeoxyglucose positron emission tomography (FDG-PET). 4.Patients who provide written informed consent to participate in the study. Key exclusion criteria - 1.Patients with severe comorbidities considered to pose a high risk for general anesthesia and pneumoperitoneum. 2.Patients with known extensive intra-abdominal adhesions that are expected to preclude adequate laparoscopic visualization. 3.Patients undergoing treatment for distant metastases from another active malignancy. 4.Pregnant or breastfeeding women. 5.Patients whom the principal investigator considers unsuitable for participation in this study. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 01 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070658

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