Minimally Invasive Versus Open Surgery for PHC
1 other identifier
observational
783
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedJune 2, 2022
May 1, 2022
8 months
May 26, 2022
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postoperative length of stay
defined as the time from being admitted to hospital to discharge
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
through study completion, an average of 5 year
Secondary Outcomes (9)
Operation time
intraoperative
postoperative complications
up to 90 days
Reoperation within 90 days
up to 90 days
Mortality
up to 90 days
Readmission within 90 days
up to 90 days
- +4 more secondary outcomes
Study Arms (2)
minimally invasive surgery
open surgery
Interventions
This is an observational study without any intervention.
Eligibility Criteria
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.
You may qualify if:
- Histologically confirmed PHC.
You may not qualify if:
- Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
- Non-adenocarcinoma histology;
- Incomplete clinical data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Renyi Qinlead
Study Sites (1)
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Related Publications (1)
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.
PMID: 37138243DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 26, 2022
First Posted
June 2, 2022
Study Start
May 1, 2018
Primary Completion
January 1, 2019
Study Completion
April 1, 2022
Last Updated
June 2, 2022
Record last verified: 2022-05