UMIN-CTR Clinical Trial

Public title

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)

Acronym

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)

Scientific Title

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)

Scientific Title:Acronym

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)

Region

Japan

Condition

pancreatic body and tail cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the possibility of tumor cell leakage into the abdominal cavity by transgastric EUS-FNA for pancreatic body tail cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Percentage of positive abdominal lavage cytology after EUA-FNA

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

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 camera port. Two additional trocars with a lumen of 5 mm are inserted from the right or left side of the abdomen for observation of the abdominal cavity. A tube with a side hole is inserted through the lateral trocar, 100 ml of saline solution is injected into the pelvic floor, and the intraperitoneal wash water is collected and submitted for intraoperative rapid cytology. If the results of the rapid cytology are negative, a 19Fr silicone drain is placed into the deepest part of the pelvis from the caudal part of the lateral abdominal trocar and fixed to the body surface. After closing the wound and terminating the surgery, a backpack is connected to the drain. If the result of rapid cytology is positive, the protocol is discontinued. EUS-FNA is performed in the morning of the day following laparoscopy in the endoscopy room. The patient is placed in the left lateral recumbent position, the ultrasound endoscope is inserted through the mouth, and a 22G Franseen needle is used to puncture the lesion through the stomach. After removing the inner core, a syringe is attached and 10 cc of negative pressure is applied, followed by 5 strokes of the needle in the tumor. The negative pressure is then released and the needle is removed from the tumor. After EUS-FNA, the specimen is collected in the evening of the first postoperative day, in the morning and evening of the second postoperative day, and in the morning of the third postoperative day by washing the abdominal cavity through a drain. The drain is removed after cytology on the morning of the third postoperative day. In this study, Papanicolaou classification of Class I-IV is negative (CY0) and Class V is positive (CY1).

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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).

Target sample size

20

Name of lead principal investigator

1st name	Tsutomu
Middle name
Last name	Fujii

Organization

Toyama University Hospital

Division name

Department of Surgery and Science

Zip code

9300194

Address

2630, Sugitani, Toyama

TEL

076-434-7331

Email

fjt@med.u-toyama.ac.jp

Name of contact person

1st name	Takamichi
Middle name
Last name	Igarashi

Organization

Toyama University Hospital

Division name

Department of Surgery and Science

Zip code

9300194

Address

2630, Sugitani, Toyama

TEL

076-434-7331

Homepage URL

Email

fjt@med.u-toyama.ac.jp

Institute

Toyama University Hospital

Institute

Department

Personal name

Organization

Toyama University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Center for Clinical Research, Toyama University Hospital

Address

2630, Sugitani, Toyama

Tel

076-434-7331

Email

rinri@adm.u-toyama.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

08

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

08

Month

02

Day

Date of IRB

Anticipated trial start date

2022

Year

08

Month

31

Day

Last follow-up date

2023

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

08

Month

11

Day

Last modified on

2022

Year

08

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055326