Cholangiocarcinoma, IntrahepaticNCT04072250
Surgery for Recurrent Intrahepatic Cholangiocarcinoma
An observational study of Cholangiocarcinoma, Intrahepatic and Recurrence Cholangiocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Intrahepatic, Recurrence Cholangiocarcinoma, Re-hepatectomy
- What is being tested?
- hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 216 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2017to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.
Who cannot join
- (1)Patient with R1 or R2 resection
- (2)Distant metastasis noted when laparotomy
- (3)Surgical mortality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?
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.
- Being tested
- hepatectomy
- Keywords
- Recurrent intrahepatic cholangiocarcinoma, Intrahepatic cholangiocarcinoma, Repeat hepatectomy, Metastasectomy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomyProcedure or surgery
Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Including overall survival and disease free survival
Measured: 1977~2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jun 2017
- Primary completion1 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma, IntrahepaticStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072250
- Sponsor's protocol ID
- 201701127B0
- Status last verified
- Jan 2018
- First submitted
- 26 Aug 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Recurrent Intrahepatic Cholangiocarcinoma: a Promise or an Excess?
- ClinicalTrials.gov ID
- NCT04072250
- Acronym / sponsor ID
- 201701127B0
- Keywords
- Recurrent intrahepatic cholangiocarcinoma, Intrahepatic cholangiocarcinoma, Repeat hepatectomy, Metastasectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- R0 resection for intrahepatic cholangiocarcinoma at initial diagnosis.
Key exclusion criteria (3 listed)
- (1)Patient with R1 or R2 resection
- (2)Distant metastasis noted when laparotomy
- (3)Surgical mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatectomyHepatectomy for patients with recurrent intrahepatic cholanigocarcinoma | Procedure or surgery | – |
Primary outcome
Survival
Time frame: 1977~2014
Including overall survival and disease free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, Intrahepatic and Recurrence Cholangiocarcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1977~2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.