UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014965
Receipt number R000017419
Scientific Title Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy
Date of disclosure of the study information 2014/08/27
Last modified on 2014/08/27 11:37:08

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Basic information

Public title

Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy

Acronym

Gallstone Prevention after Sleeve Gastrectomy

Scientific Title

Randomized, Prospective Comparison of Ursodiol in the Prevention of Gallstones after Sleeve Gastrectomy

Scientific Title:Acronym

Gallstone Prevention after Sleeve Gastrectomy

Region

North America


Condition

Condition

Gallstones after Weight Loss surgery

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objectives of this study were (1)to identify the incidence of cholecystopathy (gallstones or sludge) after sleeve gastrectomy; and (2) to determine the effectiveness of ursodiol administration on prevention of cholecystopathy after sleeve gastrectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gallstone development; cholecystopathy development (stones or sludge)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Ursodiol prescription

Interventions/Control_2

No Ursodiol

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

17 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Inclusion criteria were that individuals qualified for bariatric surgery according to the National Institutes of Health (1991) criteria (BMI> 35 with two co-morbidities or BMI>40 with none) and presented with healthy gallbladders, with normal liver enzymes (bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase), and were free of inflammation, obstruction, stones, and sludge as identified by abdominal ultrasound prior to surgery.

Key exclusion criteria

Individuals were excluded due to presence of cholecystopathy prior to surgery, previous cholecystectomy, history of ileostomy or ileoectomy, and presence of contraindications for ursodiol administration.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Lindsay Adams

Organization

Dr. Craig Chang Weight Loss Clinic

Division name

not applicable

Zip code


Address

6502 Nursery Drive Suite 300; Victoria, Texas

TEL

361-570-8585

Email

cchang@victoriasurgeon.org


Public contact

Name of contact person

1st name
Middle name
Last name Lindsay Adams

Organization

Dr. Craig Chang Weight Loss Clinic

Division name

not applicable

Zip code


Address

724 Taos

TEL

979-450-4423

Homepage URL


Email

lindsay.adams@detar.com


Sponsor or person

Institute

Louisiana Tech University

Institute

Department

Personal name



Funding Source

Organization

Individual

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


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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 27 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

Completed

Date of protocol fixation

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2014 Year 04 Month 30 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 04 Month 30 Day

Date analysis concluded

2014 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 27 Day

Last modified on

2014 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name