臨床研究等提出・公開システム

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)

G-Precision trial (G-Precision trial)

Takahara Naminatsu

The University of Tokyo Hospital

7-3-1 Hongo Bunkyo-ku, Tokyo, Japan

ishigakikazunaga@gmail.com

Ishigaki Kazunaga

The University of Tokyo Hospital

7-3-1 Hongo Bunkyo-ku, Tokyo, Japan

+81-3-3815-5411

ishigakikazunaga@gmail.com

Recruiting

Mar. 15, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Both

Pancreatic Cancer

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

Pancreatic cancer

EUS-FNB

Pancreatic Cancer

EUS-FNB

The success rate of CGP testing

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

+81-3-5841-0818

Jan. 16, 2024

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