Perihilar CholangiocarcinomaNCT05402618
Minimally Invasive Versus Open Surgery for PHC
An observational study of Perihilar Cholangiocarcinoma, run by Renyi Qin at 1 site in China.
Trial summary
Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perihilar Cholangiocarcinoma
- How many people
- 783 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A retrospective review of a real-world institutional databases from 10 hospitals in China identified PHC patients who underwent curative LS or OP surgery (including R0 and R1) form January 2012 and January 2019.Patients with pathologically confirmed PHC and without any evidence of distant metastasis by preoperative examinations were included.
Who may be able to join
- Histologically confirmed PHC.
Who cannot join
- Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
- Non-adenocarcinoma histology;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC)：A Multicenter Real-world Study
Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.
- Conditions
- Perihilar Cholangiocarcinoma
- Being tested
- No intervention
- Keywords
- laparoscopic, minimally invasive, open resection
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive surgery | Not described Receives: Other: No intervention | |
| open surgery | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay
defined as the time from being admitted to hospital to discharge
Measured: up to 90 days
Overall survival
defined as the duration from the first day after surgery to either the date of death or the last follow-up
Measured: through study completion, an average of 5 year
Secondary outcomes (9)
Operation time
defined as the time from skin incision or trocar placement to complete skin closure
Measured: intraoperative
postoperative complications
Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system.Postoperative biliary leakage, hemorrhage, and liver failure were defined and classified according to the criteria set out by the International Study Group of Liver Surgery (ISGLS). Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.
Measured: up to 90 days
Reoperation within 90 days
defined as any reoperation within 90 days
Measured: up to 90 days
Mortality
defined as any death within 30 days and 90 days, respectively
Measured: up to 90 days
Readmission within 90 days
defined as any readmission within 90 days
Measured: up to 90 days
Operative details
including blood transfusion, vascular resection, number of resected lymph nodes
Measured: intraoperative
R0 resection
defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins)
Measured: intraoperative
Intraoperative blood loss
recorded by the anesthetist using a vacuum system
Measured: intraoperative
Vessel reconstruction
defined as any repair or replacement of major vessels during surgery
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 May 2018
- Primary completion1 Jan 2019
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perihilar CholangiocarcinomaStudies 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
- Retrospective
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renyi Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Renyi Qin, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402618
- Sponsor's protocol ID
- TJDBPS10
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang M, Qin T, Zhang H, Li J, Deng X, Zhang Y, Zhao W, Fan Y, Li D, Chen X, Feng Y, Zhu S, Xing Z, Yu G, Xu J, Xie J, Dou C, Ma H, Liu G, Shao Y, Chen W, Liu J, Liu J, Yin X, Qin R. Laparoscopic versus open surgery for perihilar cholangiocarcinoma: a multicenter propensity score analysis of short- term outcomes. BMC Cancer. 2023 May 3;23(1):394. doi: 10.1186/s12885-023-10783-9.
PubMed 37138243
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC)：A Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT05402618
- Acronym / sponsor ID
- TJDBPS10
- Conditions
- Perihilar Cholangiocarcinoma
- Keywords
- laparoscopic, minimally invasive, open resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- Renyi QinUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 2 Jun 2022 (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.
Brief Summary: This is a multicentric, retrospective, real-world study to investigate the surgical outcomes of minimally invasive surgery compared with open surgery for Perihilar Cholangiocarcinoma (PHC), with the perioperative characteristics and long-term overall survival being compared. We aimed to find out whether the minimally invasive surgery is safe or feasible for PHC. And we also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive surgery | – | Other: No intervention |
| open surgery | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A retrospective review of a real-world institutional databases from 10 hospitals in China identified PHC patients who underwent curative LS or OP surgery (including R0 and R1) form January 2012 and January 2019.Patients with pathologically confirmed PHC and without any evidence of distant metastasis by preoperative examinations were included.
Key inclusion criteria (1 listed)
- Histologically confirmed PHC.
Key exclusion criteria (3 listed)
- Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
- Non-adenocarcinoma histology;
- Incomplete clinical data.
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 |
|---|---|---|
| No interventionThis is an observational study without any intervention. | Other | minimally invasive surgery, open surgery |
Primary outcome
Postoperative length of stay
Time frame: up to 90 days
defined as the time from being admitted to hospital to discharge
Overall survival
Time frame: through study completion, an average of 5 year
defined as the duration from the first day after surgery to either the date of death or the last follow-up
9 secondary outcomes
Operation time
Time frame: intraoperative
postoperative complications
Time frame: up to 90 days
Reoperation within 90 days
Time frame: up to 90 days
Mortality
Time frame: up to 90 days
Readmission within 90 days
Time frame: up to 90 days
Operative details
Time frame: intraoperative
R0 resection
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
Vessel reconstruction
Time frame: intraoperative
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 2 Jun 2022.
- Derived from this study: PubMed 37138243Wang M, Qin T, Zhang H, Li J, Deng X, Zhang Y, Zhao W, Fan Y, Li D, Chen X, Feng Y, Zhu S, Xing Z, Yu G, Xu J, Xie J, Dou C, Ma H, Liu G, Shao Y, Chen W, Liu J, Liu J, Yin X, Qin R. Laparoscopic versus open surgery for perihilar cholangiocarcinoma: a multicenter propensity score analysis of short- term outcomes. BMC Cancer. 2023 May 3;23(1):394. doi: 10.1186/s12885-023-10783-9.
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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 Perihilar Cholangiocarcinoma, run by Renyi Qin 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 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 2 Jun 2022. 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?
Postoperative length of stay (time frame: up to 90 days). 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 NCT05402618, which also lists 1 linked publication.
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 2 Jun 2022.