NCT04072250

Brief Summary

The investigators retrospectively reviewed the participants suffering from recurrent intrahepatic cholangiocarcinoma after curative resection and aimed to explore the predictive factors for recurrence and clarify the potential benefit of repeat hepatectomy or/with metastasectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

September 13, 2019

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

August 26, 2019

Last Update Submit

September 11, 2019

Conditions

Cholangiocarcinoma, IntrahepaticRecurrence CholangiocarcinomaRe-hepatectomy

Keywords

Recurrent intrahepatic cholangiocarcinomaIntrahepatic cholangiocarcinomaRepeat hepatectomyMetastasectomy

Outcome Measures

Primary Outcomes (1)

  • Survival

    Including overall survival and disease free survival

    1977~2014

Interventions

hepatectomyPROCEDURE

Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between January 1977 and December 2014, 452 patients underwent curative-intent, different extent of hepatectomy for ICC in the Department of General Surgery, Chang Gung Memorial Hospital, Linkou branch, Taiwan. Only 216 patients fulfilled selection criteria aforementioned.

You may qualify if:

  • R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.

You may not qualify if:

  • (1)Patient with R1 or R2 resection
  • (2)Distant metastasis noted when laparotomy
  • (3)Surgical mortality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

June 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 30, 2018

Last Updated

September 13, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)