UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Standardization of surgical procedures for laparoscopic Spiegel lobe resection: a single institutional experience
Title of the study (Brief title)	Standardization for laparoscopic Spiegel lobectomy
Region	Japan

Condition
Condition	Hepatocellular carcinoma (HCC) Colorectal liver metastasis (CRLM)
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We applied our surgical procedures to laparoscopic Spiegel lobectomy and retrospectively compared the perioperative outcomes between laparoscopic and open procedures.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative blood loss
Key secondary outcomes	Age/Sex/height/weight/BMI(body mass index)/Diagnosis(HCC or CRLM)/Child-Pugh score/Greater diameter of the tumor/Number of tumors/Past history of abdominal surgery/Operation time/RBC transfusion/Surgical margin (positive/negative)/Length of hospital stay/Postoperative complications

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent Spiegel lobe resection between 2007 and 2017 at Wakayama Medical University Hospital
Key exclusion criteria	1)Patients who refused the entry to this study 2)others
Target sample size	14

Research contact person
Name of lead principal investigator	Masaki Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama-city, Japan
TEL	073-441-0613
Email	ma@wakayama-med.ac.jp

Public contact
Name of contact person	Shinya Hayami
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Address	811-1, Kimiidera, Wakayama-city, Japan
TEL	073-441-0613
Homepage URL
Email	shin-8@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 10 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Retrospective study

Management information
Registered date	2017 Year 10 Month 18 Day
Last modified on	2017 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033824