Minimally Invasive Versus Open Surgery for PHC

Completed

• Conditions: Perihilar Cholangiocarcinoma
• Interventions: Other: No intervention

• Registration Number: NCT05402618
• Lead Sponsor: Renyi Qin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-01-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-30
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 783

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open surgery	No intervention	-
minimally invasive surgery	No intervention	-

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay	up to 90 days	defined as the time from being admitted to hospital to discharge
Overall survival	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China