Surgery for Recurrent Intrahepatic Cholangiocarcinoma | NCT04072250

Studies
Surgery for Recurrent Intrahepatic Cholangiocarcinoma

NCT04072250

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Sep 13, 2019Actual

Enrollment

216Actual

Phase

Not provided

Conditions

Cholangiocarcinoma, Intrahepatic
Recurrence Cholangiocarcinoma
Re-hepatectomy

Interventions

hepatectomy

Countries

Taiwan

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 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Oct 30, 2018Actual

First Submitted Date

Aug 26, 2019

First Submission Date that Met QC Criteria

Aug 26, 2019

First Posted Date

Aug 28, 2019Actual

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

Sep 11, 2019

Last Update Posted Date

Sep 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

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

216Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hepatectomy	Procedure	Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Including overall survival and disease free survival	1977~2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital Linkou Branch		Taoyuan		333	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided