UMIN-CTR Clinical Trial

Basic information
Public title	A clinical role of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Acronym	SLING trial
Scientific Title	A clinical role of staging laparoscopy with contrast-enhanced intraoperative ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Scientific Title:Acronym	SLING trial
Region	Japan

Condition
Condition	pancreatic ductal adenocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of staging laparoscopy with contrast-enhanced intraopeartive ultrasonography and indocyanine green fluorescent imaging for pancreatic ductal adenocarcinoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of distant organ metastasis
Key secondary outcomes	Comparison of survival rate according to the presence or absence of distant organ metastasis;

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Staging laparoscopy with indocyanine green fluorescent imaging and contrast-enhanced intraoperative ultrasonography for diagnosing occult distant organ metastasis
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Pancreatic ductal adenocarcinoma patients with CA19-9>300U/ml and tumor size>30mm
Key exclusion criteria	Patients with allagy for iodeine or indocyanine green. Cirrehosis patients with ICGR15>40.
Target sample size	31

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Saiura
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Department of Hepatobiliary Pancreatic Surgery
Zip code
Address	3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL	03-3520-0111
Email	akio.saiura@jfcr.or.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Oba
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Department of Hepatobiliary Pancreatic Surgery
Zip code
Address	3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL	03-3520-0111
Homepage URL
Email	atsushi.oba@jfcr.or.jp

Sponsor
Institute	Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 21 Day
Date of IRB	2017 Year 02 Month 20 Day
Anticipated trial start date	2017 Year 04 Month 12 Day
Last follow-up date	2019 Year 10 Month 27 Day
Date of closure to data entry	2019 Year 10 Month 27 Day
Date trial data considered complete	2019 Year 10 Month 27 Day
Date analysis concluded	2020 Year 10 Month 28 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 11 Day
Last modified on	2021 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030157