UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014183
Receipt number R000016255
Scientific Title Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure
Date of disclosure of the study information 2014/06/06
Last modified on 2017/12/07 10:56:17

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Basic information

Public title

Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure

Acronym

Technique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy

Scientific Title

Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure

Scientific Title:Acronym

Technique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy

Region

Japan


Condition

Condition

Biliary tract disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Rate of reaching the bilioenteric anastomosis accurately by the comparison of the X-ray imagings

Key secondary outcomes



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

1, Patients with Roux-en Y hepaticojejunostomy and bile tract disease.
2, Written informed consent is required from patients or legal representatives

Key exclusion criteria

1, Patients who have difficulty in endoscopic approach.
2, Patients in ECOG performance status 4.
3, Patients with serious complication in other organ.
4, Patients who have side-to-side jejunojejunal anastomosis.
5, Patients who don't give informed consent.

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironari Kato

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatolog

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan, 700-8558

TEL

086-235-7219

Email

drkatocha@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichiro Tsutsumi

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan, 700-8558

TEL

086-235-7219

Homepage URL


Email

tsutsumi@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okayama University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



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

岡山大学病院(岡山県)、広島市立広島市民病院(広島県)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.thieme-connect.com/DOI/DOI?10.1055/s-0043-117406

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

Completed

Date of protocol fixation

2014 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 26 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study for the assessment of the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis in patients with Roux-en Y hepaticojejunostomy.


Management information

Registered date

2014 Year 06 Month 06 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name