NCT01862276

Brief Summary

To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

May 14, 2013

Last Update Submit

June 29, 2014

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (2)

  • 3-year recurrence-free survival rate

    11 years (2000-2010)

  • Ratio of local recurrence at the hepatico-duodenal ligament

    11 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent hepatic lobectomy between 2000 and 2010 for intrahepatic cholangiocarcinoma, and did not undergo adjuvant chemotherapy will be included for analysis.

You may qualify if:

  • Cases of major hepatectomy due to intrahepatic cholangiocarcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University, Graduate School of Medicine

Osaka, Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Hiroaki Nagano, MD, PhD

    Osaka University Graduate School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 24, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

JP(1)