UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of short-term outcomes following laparoscopic and open distal pancreatectomy
Acronym	Comparison of short-term outcomes following laparoscopic and open distal pancreatectomy
Scientific Title	Comparison of short-term outcomes following laparoscopic and open distal pancreatectomy
Scientific Title:Acronym	Comparison of short-term outcomes following laparoscopic and open distal pancreatectomy
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to evaluate the benefits of laparoscopic surgery in distal pancreatectomy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	In-hospital morbidity, mortality, and reoperation.
Key secondary outcomes	30-day readmission, duration of anesthesia and drainage, postoperative length of stay, and total hospitalization costs.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Using a Japanese national inpatient database, we identified patients who underwent laparoscopic or open distal pancreatectomy between April 2012 and March 2020.
Key exclusion criteria	We excluded patients who (i) were < 18 years old, (ii) had stage IV pancreatic cancer, and (iii) underwent resection of surrounding organs at the same time as the pancreatectomy.
Target sample size	20000

Research contact person
Name of lead principal investigator	1st name Takaaki Middle name Last name Konishi
Organization	The University of Tokyo
Division name	Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0338155411
Email	takaakonishi-ncd@umin.ac.jp

Public contact
Name of contact person	1st name Takaaki Middle name Last name Konishi
Organization	The University of Tokyo
Division name	Department of Breast and Endocrine Surgery, Graduate School of Medicine
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0338155411
Homepage URL
Email	takaakonishi-ncd@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	7-3-1 Hongo, Bunkyo-ku, Tokyo
Email	NA

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	2022 Year 03 Month 10 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	28490
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	2022 Year 04 Month 01 Day
Date of IRB	2022 Year 05 Month 01 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This nationwide retrospective cohort study was performed using the Diagnosis Procedure Combination database, which includes hospital administrative claims data and discharge abstracts of approximately 8,000,000 inpatients in more than 1000 hospitals throughout Japan, covering approximately half of all inpatient admissions to acute-care hospitals in Japan. All 82 university hospitals are obliged to participate in the database; participation by community hospitals is voluntary.

Management information
Registered date	2022 Year 03 Month 10 Day
Last modified on	2022 Year 03 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053775