International Registry on Cholangiocarcinoma Treatment
Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
Cholangiocarcinoma is a rare and very aggressive neoplasm that arises from the biliary
epithelium, constitutes approximately 2% of all reported cancer, and accounts for about 3% of
all gastrointestinal malignancies. Up to date, there are many modalities to diagnosis and
treat with a range of sensitivity and specificity, and also the advantage and disadvantage of
its modality. Cholangiocarcinoma has a poor prognosis. Surgical resection offers the only
curative option and usually requires a major hepatic resection in addition to resection of
the cholangiocarcinoma. Unfortunately, curative resection is possible in only about 30% of
patients due to locally advanced disease, distant metastases or comorbidity in elderly
patients. Even after resection, the recurrence rate is approximately 60%, resulting in a low
5-year overall survival (OS).
Patients with intra-hepatic Cholangiocarcinoma (ICC) have a very limited benefit from
systemic chemotherapy, indeed, in unresectable cholangiocarcinoma Overall Survival with
systemic chemotherapy is less than 1 year. Since most cholangiocarcinoma patients develop
distant metastases at late stages only, locoregional therapy is an interesting therapeutic
strategy.
Locoregional therapy studies in patients with intrahepatic cholangiocarcinoma employing
radiofrequency ablation (RFA), transarterial chemoembolization (TACE) or external as well as
internal radiation therapy yielded promising results in the last couple of years.
TACE is safe and may be effective for prolonging the survival of patients with nonresectable
combined hepatocellular carcinoma (HCC) -cholangiocarcinoma, as compared with the
historically reported survivals of these patients. Tumor vascularity is highly associated
with tumor response. The patient survival period after TACE for combined
HCC-cholangiocarcinoma is significantly dependent on tumor size, tumor vascularity,
Child-Pugh class, and presence or absence of portal vein invasion.
Currently, few centers perform TACE therapy for unresectable Cholangiocarcinoma. Several
European studies have reported the efficacy and safety TACE for ICC.
The establishment of a registry to obtain the majority of Cholangiocarcinoma cases treated
with locoregional approach within and outside Europe can help the investigators evaluate a
larger and non-ambiguous sample population. This would help the investigators evaluate the
technical success rates, clinical success rates, feasibility and safety of TACE for ICC.