UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041315
Receipt number R000046884
Scientific Title Randomized controlled trial of liver retraction methods for laparoscopic gastrectomy and gastric tube reconstruction.
Date of disclosure of the study information 2020/08/04
Last modified on 2020/08/03 21:04:03

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Basic information

Public title

Randomized controlled trial of liver retraction methods for laparoscopic gastrectomy and gastric tube reconstruction.

Acronym

A comparative study of liver retraction methods for laparoscopic gastric surgery.

Scientific Title

Randomized controlled trial of liver retraction methods for laparoscopic gastrectomy and gastric tube reconstruction.

Scientific Title:Acronym

A comparative study of liver retraction methods for laparoscopic gastric surgery.

Region

Japan


Condition

Condition

Laparoscopic gastorectomy for gastric cancer or laparoscopic gastric tube reconstruction for esophageal/esophagogastric junctional cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To indicate the safety and efficacy of using a silicone disk together with intraoperative liver retraction in patients undergoing laparoscopic gastrectomy and gastric tube reconstruction.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change rate of AST and ALT from 1 day after the surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using nlyf the Nathanson liver retractor during liver retraction in laparoscopic surgery.

Interventions/Control_2

Placing a silicon disc between the Nathanson liver retractor and the liver during liver retraction in laparoscopic surgery.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients undergoing laparoscopic gastrectomy (distal gastrectomy, proximal gastrectomy, total gastrectomy, partial resection) for gastric cancer or laparoscopic gastric tube reconstruction for esophageal cancer/esophagogastric junctional cancer.

Key exclusion criteria

Patients were excluded in case that the preoperative contrast-enhanced CT examination reveals the extraordinary blood vessels (accessory LHA, replaced LHA) , and the investigator determined that it was difficult to preserve in the surgery.
Patients who are scheduled to undergo simultaneous surgery for synchronous cancers or cholelithiasis.Patients were also excluded if they had severe heart disease(NYHA III-IV), liver and renal dysfunction, uncontrollable diabetes(HbA1c>8.0%), and pregnancy.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Hiroya
Middle name
Last name Takeuchi

Organization

Hamamatsu University School of Medicine

Division name

Department of Surgery

Zip code

4313192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Email

takeuchi@hama-med.ac.jp


Public contact

Name of contact person

1st name Wataru
Middle name
Last name Soneda

Organization

Hamamatsu University School of Medicine

Division name

Department of Surgery

Zip code

4313192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

TEL

053-435-2279

Homepage URL


Email

41235344@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN

Tel

053-435-2680

Email

rinri@hama-med.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

2020 Year 08 Month 04 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

Preinitiation

Date of protocol fixation

2020 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 03 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 04 Day

Last modified on

2020 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name