UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Acronym	Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Scientific Title	Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Scientific Title:Acronym	Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish the indications for staging laparoscopy in pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysis of risk factors predicting radiologically undetectable micrometastases in pancreatic cancer
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients who are histologically or cytologically diagnosed as pancreatic cancer (2) No distant metastasis in radiological imaging tests at the initial diagnosis (3) Pancreatic cancer patients determined to have indications of treatment intended for resection
Key exclusion criteria	(1) Patients who are not histologically or cytologically diagnosed as pancreatic cancer (2) Distant metastasis in radiological imaging tests (3) Patients with concurrent active multiple cancers at the enrollment (4) Patients with poor general condition who are determined to have no indication for staging laparoscopy or treatment intended for resection
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Masamichi Middle name Last name Mizuma
Organization	Tohoku University
Division name	Department of Surgery
Zip code	980-8574
Address	1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL	022-717-7205
Email	masamichi@surg.med.tohoku.ac.jp

Public contact
Name of contact person	1st name Masamichi Middle name Last name Mizuma
Organization	Tohoku University
Division name	Department of Surgery
Zip code	980-8574
Address	1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL	022-717-7205
Homepage URL
Email	masamichi@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	KUROKAWA CANCER RESEARCH FOUNDATION
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	Tohoku University
Address	1-2 Seiryomachi, Aobaku, Sendai, Japan
Tel	022-717-7056
Email	med-kenkyo@grp.tohoku.ac.jp

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	2021 Year 08 Month 01 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	Open public recruiting
Date of protocol fixation	2021 Year 06 Month 04 Day
Date of IRB	2021 Year 07 Month 08 Day
Anticipated trial start date	2021 Year 07 Month 27 Day
Last follow-up date	2026 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 07 Month 31 Day
Last modified on	2021 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050821