UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002910
Receipt number R000003547
Scientific Title laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine
Date of disclosure of the study information 2009/12/17
Last modified on 2009/12/16 18:59:22

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Basic information

Public title

laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine

Acronym

laparoscopic-endoscopic cooperative surgery

Scientific Title

laparoscopic-endoscopic cooperative surgery for stomach, duodenum and intestine

Scientific Title:Acronym

laparoscopic-endoscopic cooperative surgery

Region

Japan


Condition

Condition

cancer,adenoma,SMT,cartinoid

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To show a surgical approach to remove stomach, duodenal and intestinal lesions using laparoscopic-endoscopic cooperative surgery (LECS) is minimally invasive and achieved excellent outcome.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

morbidity,mortality,the duration of hospital stay,survival

Key secondary outcomes

patient satisfaction


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

patient who has stomach or duodenal or intestinal lesion

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

10 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

patient who has stomach or duodenal or intestinal lesion

Key exclusion criteria

patient who cannot be given general anesthesia

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koide Naohiko

Organization

Shinshu University School of Medicine

Division name

Department of Digestive Surgery

Zip code


Address

3-1-1, Asahi, Matsumoto City, 390-8621, Nagano Prefecture, Japan.

TEL

0263-37-2654

Email



Public contact

Name of contact person

1st name
Middle name
Last name Sakon Masahiro

Organization

Shinshu University School of Medicine

Division name

Department of Digestive Surgery

Zip code


Address

3-1-1, Asahi, Matsumoto City, 390-8621, Nagano Prefecture, Japan.

TEL

0263-37-2654

Homepage URL

http://wwwhp.md.shinshu-u.ac.jp/

Email

sakon@shinshu-u.ac.jp


Sponsor or person

Institute

Department of Digestive Surgery Shinshu University School of Medicine,

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

信州大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 17 Day


Related information

URL releasing protocol

http://wwwhp.md.shinshu-u.ac.jp/

Publication of results

Unpublished


Result

URL related to results and publications

http://wwwhp.md.shinshu-u.ac.jp/

Number of participants that the trial has enrolled


Results

The postoperative course was uneventful

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

2009 Year 12 Month 16 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2019 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2009 Year 12 Month 16 Day

Last modified on

2009 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003547


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name