Minimally Invasive Versus Open Surgery for PHC

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

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.

Study Overview

• Status: Completed
• Conditions: Perihilar Cholangiocarcinoma
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 783

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
minimally invasive surgery	Other: No intervention; This is an observational study without any intervention.
open surgery	Other: No intervention; This is an observational study without any intervention.

What is the study measuring?

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
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
Intraoperative blood loss	recorded by the anesthetist using a vacuum system	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
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
Vessel reconstruction	defined as any repair or replacement of major vessels during surgery	intraoperative

Collaborators and Investigators

• Sponsor: Renyi Qin

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic; minimally invasive; open resection
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: TJDBPS10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No