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Pilot study to evaluate oncological SAFEty of endoscopic ultrasound-guided Fine-Needle Aspiration biopsy by staging laparoscopy in pancreatic body-tail cancer(SAFE-FNA trial)

Pilot study to evaluate oncological SAFEty of endoscopic ultrasound-guided Fine-Needle Aspiration biopsy by staging laparoscopy in pancreatic body-tail cancer(SAFE-FNA trial) - Pilot study to evaluate oncological SAFEty of endoscopic ultrasound-guided Fine-Needle Aspiration biopsy by staging laparoscopy in pancreatic body-tail cancer(SAFE-FNA trial)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048649
Enrollment
50
Registered
2022-08-11
Start date
2022-08-31
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 body and tail cancer

Interventions

The laparoscopy is performed in the operating room in the supine position under general anesthesia. A trocar with a balloon with a lumen of 5 mm or 12 mm is inserted from the umbilicus to serve as the

Sponsors

Toyama University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Patients must be at least 20 years old. (2)Patients with lesions suspected to be invasive pancreatic ductal carcinoma (Pancreatic Cancer Treatment Regulations, 7th Edition) on various imaging examinations (3)Patients with lesions located in the pancreatic tail (4)Patients with ECOG performance status 0-2 (5) Patients with a negative result (CY0) on laparoscopic examination by laparoscopic cytology (6) Patients who require histological diagnosis by EUS-FNA to determine or select a treatment strategy. (7)Patients for whom transgastric EUS-FNA is anticipated.

Exclusion criteria

Exclusion criteria: (1)Patients who have been previously treated for pancreatic cancer (2)Patients who have already undergone laparoscopy and EUS-FNA in the past (3)Patients who are difficult to administer general anesthesia (4) Patients with bleeding tendency (PT INR >1.5 or Plt <50,000 micro L). (5) Patients who cannot discontinue antithrombotic drugs (6) Patients with inability to visualize masses by EUS due to a history of gastrectomy, etc. (7)Patients with blood vessels or other tumors in the puncture route according to various imaging examinations performed prior to enrollment. (8)Patients who are judged to be inappropriate as subjects by the investigator(subinvestigator).

Design outcomes

Primary

MeasureTime frame
Percentage of positive abdominal lavage cytology after EUA-FNA

Countries

Japan

Contacts

Public ContactMina Fukasawa

Toyama University Hospital Department of Surgery and Science

fjt@med.u-toyama.ac.jp076-434-7331

Outcome results

None listed

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