Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

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.

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