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G-Precision trial

A Multicenter Randomized Comparison of 22G FNB Needle vs. 19G FNB Needle in Ultrasound Endoscopy-Guided Tissue Collection for Cancer Gene Panel Testing in Unresectable Advanced or Recurrent Pancreatic Cancer - G-Precision trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230578
Enrollment
100
Registered
2024-01-19
Start date
2024-03-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer Pancreatic cancer

Interventions

Allocated 1:1 between 22G FNB and 19G FNB groups

Sponsors

Takahara Naminatsu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable advanced or recurrent pancreatic cancer diagnosed by pathological or imaging findings 2) Patients who are scheduled to undergo EUS-TA 3) Patients who are scheduled to undergo CGP examination using EUS-TA specimen at the time of completion or expected completion of standard treatment. 4) 18 years of age or older 5) Patients who are expected to survive more than 3 months. 6) Patients who have been fully informed about the study, understand it, and give written consent of their own free will.

Exclusion criteria

Exclusion criteria: 1) Patients with resectable pancreatic cancer or borderline resectable pancreatic cancer who are scheduled for surgery in the future 2) Patients with performance status 3-4 3) Patients who have difficulty in receiving anti-tumor therapy 4) Patients with bleeding tendency (platelets <50,000/mm3, PT <70%) (however, patients who recover with blood transfusion or vitamin K administration may be enrolled) 5) Patients at high risk of thromboembolism due to withdrawal of antithrombotic drugs and for whom withdrawal or replacement of antithrombotic drugs based on the "Guidelines for Gastrointestinal Endoscopy for Patients Taking Antithrombotic Drugs" is not possible. 6) Patients with heart failure (NYHA classification III-IV) or respiratory failure (PaO2 < 60 Torr) 7) Patients who are pregnant or may become pregnant 8) Other cases that the principal investigator determines to be inappropriate as a research subject.

Design outcomes

Primary

MeasureTime frame
The success rate of CGP testing

Secondary

MeasureTime frame
1) Procedural success rate 2) Tissue sample collection rate 3) Diagnosis rate of benign and malignant cases 4) CGP proper specimen collection rate 5) DNA yield 6)Detection rate of genetic abnormality of therapeutic target 7)TMB 8)Adverse events by EUS-TA 9)Tissue area, tumor (cell) content*, and tumor (area) content by HE staining

Contacts

Public ContactKazunaga Ishigaki

The University of Tokyo Hospital

ishigakikazunaga@gmail.com+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026