Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholangiocarcinoma, Perihilar, Surgery

Intervention / Treatment
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* Procedure: Three dimensional laparoscopic resection for pCCA
* Procedure: Open resection for pCCA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven pCCA. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence. Preoperative staging work up performed by upper abdomen enhanced CT scan. The subject understands the nature of this trial and willing to comply. Ability to provide written informed consent. Patients treated with curative intent in accordance to international guidelines Exclusion Criteria: Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs. Subjects undergoing any part for hepatectomy. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4. Synchronous malignancy in other organs. Palliative surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D approach<br>Three dimensional laparoscopic resection for pCCA | Procedure: Three dimensional laparoscopic resection for pCCA<br>* Three dimensional laparoscopic resection for pCCA<br>|
| Experimental: open approach<br>Open resection for pCCA | Procedure: Open resection for pCCA<br>* Open resection for pCCA<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma perihilar, three dimension laparoscopic