Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

October 5, 2020 updated by: Renyi Qin, Tongji Hospital

Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.

This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically proven pCCA.
  2. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
  3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
  4. The subject understands the nature of this trial and willing to comply.
  5. Ability to provide written informed consent.
  6. Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

  1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
  2. Subjects undergoing any part for hepatectomy.
  3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
  4. Synchronous malignancy in other organs.
  5. Palliative surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D approach
Three dimensional laparoscopic resection for pCCA
Procedure: Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA
Experimental: open approach
Open resection for pCCA
Procedure: Open resection for pCCA
Open resection for pCCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 24 months
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
24 months
Length of Stay
Time Frame: 24 months
Length of stay was defined as the postoperative time interval in days.
24 months
R0 Resection Rate
Time Frame: 24 months
Negative margin rate.
24 months
Bile leakage
Time Frame: 24 months
The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.
24 months
TNM Staging
Time Frame: 24 months
According to AJCC guideline, each patients TNM staging were recorded.
24 months
Complication rate
Time Frame: 24 months
Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJDBPS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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