Long-term Effects of Cancer TreatmentNCT05117047

A Long-term Survival Analysis of Different Surgical Method in Early Hepatocellular Carcinoma

An observational study of Long-term Effects of Cancer Treatment, run by Chen Xiaoping at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators established three prospective cohorts of patients with BCLC stage 0-A HCC, based on different surgical approaches (open, laparoscopic and robotic). After 5 years of follow-up, the investigators used propensity score matching (PSM) to reduce selection bias and then compared the long-term oncological… Read more about this study

Who is it for?: Ages 14 to 75 years
Conditions the study is for: Long-term Effects of Cancer Treatment
What is being tested?: liver resection
Type of treatment: Surgery or procedure
How many people: 369 participants
Where: 1 siteChina
Study dates: 14 Feb 2015to 30 Jun 2021
How long will I take part?: 5 Years
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 14 to 75 years
All sexes
Child, Adult, Older adult

Study population: 1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR. Among these patients, there were 102, 333, and 669 HCC patients, respectively. Ten patients were excluded due to missing data or follow-up. Finally, 369 HCC patients in the early stages were included in the analysis. After PSM, 168 patients were matched and there were 56 patients in each group

Who may be able to join

All HCC patients in BCLC stage 0-A underwent liver resection in hepatic surgery center, Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology. The inclusion criteria were as follows: 14- 75 years old

Who cannot join

with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.

Trial locations and contacts

1 site in 1 country.

China1 site

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Long-term Survival Analysis of Robotic, Laparoscopic and Open Liver Resection for Hepatocellular Carcinoma in BCLC Stage 0-A: A Prospective Cohort Study With Matched Comparison

Read the detailed description

In this study, three prospective cohorts of patients with BCLC stage 0-A HCC, underwent complete liver resection using different surgical approaches (OLR, LLR, and RALR), were established. After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.

Conditions: Long-term Effects of Cancer Treatment
Being tested: liver resection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liver resectionProcedure or surgery
After adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.

Study groups in NCT05117047
Study group	Role	What they receive
robot-assisted liver resection		In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 71 HCC patients were included in robotic liver resection cohort. Receives: Procedure: liver resection
laparoscopic liver resection		In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 141 HCC patients were included in laparoscopic liver resection cohort. Receives: Procedure: liver resection
open liver resection		In this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 157 HCC patients were included in open liver resection cohort. Receives: Procedure: liver resection

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
The primary outcomes of this study included long-term oncological outcomes of OS
Measured: 14/02/2015-30/06/2021
Disease free Survival
The primary outcomes of this study included long-term oncological outcomes of DFS
Measured: 14/02/2015-30/06/2021

Secondary outcomes (2)

postoperative complications
Postoperative morbidity and mortality were assessed according to the Clavien-Dindo classification
Measured: 14/02/2015-30/06/2021
Textbook Outcome in liver surgery (TOLS)
Textbook Outcome in liver surgery (TOLS), was defined as the absence of intraoperative incidents of grade 2 or higher, postoperative bile leak grade B or C, severe postoperative complications, readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin.
Measured: 14/02/2015-30/06/2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 201530 Jun 2021

First posted11 Nov 2021
Study start14 Feb 2015
Primary completion30 Jun 2017
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Long-term Effects of Cancer TreatmentStudies of the same condition, open and under way.
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: Cohort
Time perspective: Prospective
Enrolment: 369 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05117047
Sponsor's protocol ID: C201501
Status last verified: Nov 2021
First submitted: 3 Nov 2021
Last updated: 11 Nov 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Long-term Effects of Cancer Treatment trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Survival Analysis of Robotic, Laparoscopic and Open Liver Resection for Hepatocellular Carcinoma in BCLC Stage 0-A: A Prospective Cohort Study With Matched Comparison
ClinicalTrials.gov ID: NCT05117047
Acronym / sponsor ID: C201501
Conditions: Long-term Effects of Cancer Treatment
Study type: Observational
Recruitment status: Completed
Enrolment: 369 participants (actual)
Lead sponsor: Chen XiaopingUniversity, hospital or other
Study start: 14 Feb 2015 (actual)
Primary completion: 30 Jun 2017 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 11 Nov 2021 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 3

Arm	Type	Receives
robot-assisted liver resection	–	Procedure: liver resectionIn this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 71 HCC patients were included in robotic liver resection cohort.
laparoscopic liver resection	–	Procedure: liver resectionIn this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 141 HCC patients were included in laparoscopic liver resection cohort.
open liver resection	–	Procedure: liver resectionIn this study, the investigators included all HCC patients with BCLC stage 0-A (n=1669) who underwent hepatectomy over an 1 ½ year study period, and divided them into three study cohorts according to the operations they received. These were consecutive patients who met the inclusion criteria of the study. 157 HCC patients were included in open liver resection cohort.

Who may qualify

Ages: 14 to 75 years
Sex: All
Age groups: Child, Adult, Older adult
Study population: 1669 cases underwent liver resection from July 1st 2015 to June 30th 2017 in Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, including 186 RALR, 527 LLR, and 956 OLR. Among these patients, there were 102, 333, and 669 HCC patients, respectively. Ten patients were excluded due to missing data or follow-up. Finally, 369 HCC patients in the early stages were included in the analysis. After PSM, 168 patients were matched and there were 56 patients in each group

Key inclusion criteria (1 listed)

All HCC patients in BCLC stage 0-A underwent liver resection in hepatic surgery center, Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology. The inclusion criteria were as follows: 14- 75 years old

Key exclusion criteria (1 listed)

with any history of malignant tumors; with treatment of ablation, TACE or TKI history before liver resection.

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
liver resectionAfter adequate periods of follow-up, the long-term oncological outcomes of the three different surgical approaches were compared, providing a higher level of evidence using a non-randomized comparative study based on propensity score matching (PSM) analysis.	Procedure or surgery	laparoscopic liver resection, open liver resection, robot-assisted liver resection

Primary outcome

Overall Survival
Time frame: 14/02/2015-30/06/2021
The primary outcomes of this study included long-term oncological outcomes of OS
Disease free Survival
Time frame: 14/02/2015-30/06/2021
The primary outcomes of this study included long-term oncological outcomes of DFS

2 secondary outcomes

postoperative complications
Time frame: 14/02/2015-30/06/2021
Textbook Outcome in liver surgery (TOLS)
Time frame: 14/02/2015-30/06/2021

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 11 Nov 2021.

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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.

Xiaoping Chen, Dr study chair

Tongji Hospital

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 Long-term Effects of Cancer Treatment, run by Chen Xiaoping at 1 site in China.

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 1 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 11 Nov 2021. 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 China. 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?

Overall Survival (time frame: 14/02/2015-30/06/2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05117047.

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 11 Nov 2021.