Minimally Invasive Versus Open Surgery for PHC

Perihilar Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402618
• Other study ID #: TJDBPS10
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 783
• Est. completion date: April 1, 2022
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Klatskin Tumor
• Perihilar Cholangiocarcinoma

Intervention

Other:
• No intervention
This is an observational study without any intervention.

Locations

Country	Name	City	State
China	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renyi Qin

Country where clinical trial is conducted

China, 

Outcome

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