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Clinical Trials/NCT05402618
NCT05402618
Completed
Not Applicable

Minimally Invasive Versus Open Surgery for Perihilar Cholangiocarcinoma(PHC):A Multicenter Real-world Study

Renyi Qin1 site in 1 country783 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perihilar Cholangiocarcinoma
Sponsor
Renyi Qin
Enrollment
783
Locations
1
Primary Endpoint
Postoperative length of stay
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
April 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Renyi Qin
Responsible Party
Sponsor Investigator
Principal Investigator

Renyi Qin

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed PHC.

Exclusion Criteria

  • Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites;
  • Non-adenocarcinoma histology;
  • Incomplete clinical data.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Operation time(intraoperative)
  • Mortality(up to 90 days)
  • Operative details(intraoperative)
  • Intraoperative blood loss(intraoperative)
  • postoperative complications(up to 90 days)
  • Reoperation within 90 days(up to 90 days)
  • Readmission within 90 days(up to 90 days)
  • Vessel reconstruction(intraoperative)
  • R0 resection(intraoperative)

Study Sites (1)

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