Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Overview

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.

Full Title of Study: “Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2018

Interventions

  • Procedure: Three dimensional laparoscopic resection for pCCA
    • Three dimensional laparoscopic resection for pCCA
  • Procedure: Open resection for pCCA
    • Open resection for pCCA

Arms, Groups and Cohorts

  • Experimental: 3D approach
    • Three dimensional laparoscopic resection for pCCA
  • Experimental: open approach
    • Open resection for pCCA

Clinical Trial Outcome Measures

Primary Measures

  • Mortality
    • Time Frame: 24 months
    • Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
  • Length of Stay
    • Time Frame: 24 months
    • Length of stay was defined as the postoperative time interval in days.
  • R0 Resection Rate
    • Time Frame: 24 months
    • Negative margin rate.
  • 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.
  • TNM Staging
    • Time Frame: 24 months
    • According to AJCC guideline, each patients TNM staging were recorded.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tongji Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Renyi Qin, Clinical professor – Tongji Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.