Surgery for Recurrent Intrahepatic Cholangiocarcinoma

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04072250
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Actual Duration (Months): 17
• Patients Per Site Per Month: 12.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma, Intrahepatic; Recurrence Cholangiocarcinoma; Re-hepatectomy	Procedure: hepatectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 216 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Oct 1, 2018
• Actual Study Completion Date: Oct 30, 2018

Outcome Measures

Primary Outcome Measures

1. Survival [1977~2014]

   Including overall survival and disease free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital Linkou Branch	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04072250
• Other Study ID Numbers: 201701127B0
• First Posted: Aug 28, 2019
• Last Update Posted: Sep 13, 2019
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gung Memorial Hospital: Recurrent intrahepatic cholangiocarcinoma; Intrahepatic cholangiocarcinoma; Repeat hepatectomy; Metastasectomy
• Additional relevant MeSH terms: Cholangiocarcinoma; Recurrence

Study Results

No Results Posted as of Sep 13, 2019