Estimation of Standard Liver Volume in the Indian Population | NCT01143935

Studies
Estimation of Standard Liver Volume in the Indian Population

NCT01143935

Sponsor

All India Institute of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 15, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Liver

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Dec 2010Estimated

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2010

Last Update Posted Date

Jun 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Estimation of liver volume is important for live donor liver transplant as well as extended liver resections. Computed tomography (CT) volumetry which is currently a gold standard for liver volumetry , is a time consuming process. A quicker method to estimate liver volume is essential. The aim of the present study is to try and formulate an equation based on patients height, weight etc to estimate liver volume.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Live patients		All patients undergoing CT scans of the abdomen for non hepatobiliary conditions
Autopsy cases		All autopsy cases with no liver disease or trauma.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients undergoing CT scans

Autopsy cases

Exclusion Criteria:

Patients with hepatobiliary disorders Autopsy cases with liver disease or trauma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing CT scans for non hepatobiliary conditions. Autopsy cases in whom there is no liver disease or trauma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gaurav N Chaubal, MS Gen Surg	Contact	9953962913		gauravdr18@yahoo.co.in

Overall Officials

Name	Affiliation	Role
Tushar K Chattopadhyaya, MS Surgery	All India Institute of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AIIMS	Recruiting	New Delhi	National Capital Territory of Delhi	010029	India