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Minimally Invasive Versus Open Surgery for PHC

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05402618
Enrollment
783
Registered
2022-06-02
Start date
2018-05-01
Completion date
2022-04-01
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perihilar Cholangiocarcinoma

Keywords

laparoscopic, minimally invasive, open resection

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.

Interventions

OTHERNo intervention

This is an observational study without any intervention.

Sponsors

Renyi Qin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Histologically confirmed PHC.

Exclusion criteria

1. Peritoneal seeding or metastasis to the liver, para-aortic lymph nodes, or distant sites; 2. Non-adenocarcinoma histology; 3. Incomplete clinical data.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative length of stayup to 90 daysdefined as the time from being admitted to hospital to discharge
Overall survivalthrough study completion, an average of 5 yeardefined as the duration from the first day after surgery to either the date of death or the last follow-up

Secondary

MeasureTime frameDescription
postoperative complicationsup to 90 daysPostoperative 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.
Reoperation within 90 daysup to 90 daysdefined as any reoperation within 90 days
Mortalityup to 90 daysdefined as any death within 30 days and 90 days, respectively
Vessel reconstructionintraoperativedefined as any repair or replacement of major vessels during surgery
Operative detailsintraoperativeincluding blood transfusion, vascular resection, number of resected lymph nodes
R0 resectionintraoperativedefined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins)
Intraoperative blood lossintraoperativerecorded by the anesthetist using a vacuum system
Readmission within 90 daysup to 90 daysdefined as any readmission within 90 days
Operation timeintraoperativedefined as the time from skin incision or trocar placement to complete skin closure

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026