UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039775
Receipt number R000045363
Scientific Title Laparoscopic and endoscopic cooperative surgery for cholecystogastric fistula: A case report
Date of disclosure of the study information 2020/03/12
Last modified on 2020/07/13 20:20:53

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Basic information

Public title

Laparoscopic and endoscopic cooperative surgery for cholecystogastric fistula: A case report

Acronym

LECS for cholecystogastric fistula

Scientific Title

Laparoscopic and endoscopic cooperative surgery for cholecystogastric fistula: A case report

Scientific Title:Acronym

LECS for cholecystogastric fistula

Region

Japan


Condition

Condition

Cholecystogastric fistula

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A case report on safe surgical procedure for cholecystogastric fistula

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

perioperative complications

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

84 years-old <=

Age-upper limit

84 years-old >=

Gender

Male

Key inclusion criteria

An-84-year-old man with cholecystogastric fistula

Key exclusion criteria

none

Target sample size

1


Research contact person

Name of lead principal investigator

1st name Goshi
Middle name
Last name Fujimoto

Organization

Ofuna Chuo Hospital

Division name

Gastroenterological surgery

Zip code

235-0036

Address

1-3-39-503, Nakahara, Isogo-ku, Yokohama city, Kanagawa prefecture

TEL

09021690887

Email

g_chimera_7@yahoo.co.jp


Public contact

Name of contact person

1st name Goshi
Middle name
Last name Fujimoto

Organization

Ofuna Chuo Hospital

Division name

Gastroenterological surgery

Zip code

235-0036

Address

1-3-39-503, Nakahara, Isogo-ku, Yokohama city, Kanagawa prefecture

TEL

09021690887

Homepage URL


Email

g_chimera_7@yahoo.co.jp


Sponsor or person

Institute

Ofuna Chuo Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Ofuna Chuo Hospital

Address

6-2-24, Ofuna, Kamakura, Kanagawa 247-0056, Japan

Tel

0467-45-2111

Email

jun-segawa@ofunachuohp.net


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 03 Month 12 Day


Related information

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242993/pdf/main.pdf

Publication of results

Unpublished


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242993/pdf/main.pdf

Number of participants that the trial has enrolled

1

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

2019 Year 05 Month 25 Day

Date of IRB

2019 Year 07 Month 18 Day

Anticipated trial start date

2019 Year 05 Month 25 Day

Last follow-up date

2019 Year 07 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Case report


Management information

Registered date

2020 Year 03 Month 11 Day

Last modified on

2020 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name