Minimally Invasive Versus Open Surgery for PHC

Study Overview
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Brief Summary
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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.

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

Conditions
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Perihilar Cholangiocarcinoma

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| minimally invasive surgery<br> | Other: No intervention<br>* This is an observational study without any intervention.<br>|
| open surgery<br> | Other: No intervention<br>* This is an observational study without any intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | defined as the time from skin incision or trocar placement to complete skin closure | 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. | up to 90 days | 
| Reoperation within 90 days | defined as any reoperation within 90 days | up to 90 days | 
| Mortality | defined as any death within 30 days and 90 days, respectively | up to 90 days | 
| Readmission within 90 days | defined as any readmission within 90 days | up to 90 days | 
| Operative details | including blood transfusion, vascular resection, number of resected lymph nodes | intraoperative | 
| R0 resection | defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins) | intraoperative | 
| Intraoperative blood loss | recorded by the anesthetist using a vacuum system | intraoperative | 
| Vessel reconstruction | defined as any repair or replacement of major vessels during surgery | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic, minimally invasive, open resection