💬In plain words
What the trial is, and whether it could suit you
Surgery for hilar cholangiocarcinoma (phCCA) remains a significant challenge. The minority of patients who are eligible for resection are exposed to high procedure-related morbidity and mortality, and despite apparent R0 resection, cancer recurrence is common. The benefit of R1 resection compared to the best palliative chemotherapy has been questioned. The concept of extended surgery to achieve better radicality is controversial and in many instances, associated with higher procedure-related risk and unclarified oncological benefit. For unresectable patients, liver transplantation, per the Mayo protocol, remains the only alternative for a few patients.
Optimal staging pre- and intraoperatively is problematic since only the local biliary ductal involvement and, to a certain extent, lymph node dissemination can be reasonably correctly assessed. The reliability and validity of the intraope
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Histologically verified or strong suspicion of cholangiocarcinoma based on radiology and endoscopy and elevated Ca 19-9 \> 100U/L
* Perihilar cholangiocarcinoma that is deemed unresectable based on tumor location or severity of the underlying liver disease. Perihilar recurrence in PSC patients more than 24 months following the previous resection (N0, R0, no macrovascular involvement) is accepted.
* Patients should not be eligible for liver transplantation according to the Mayo protocol criteria.
* Tumor involvement of the hepatic artery distal to the gastroduodenal artery or the portal vein without tumor thrombus is accepted.
* No evidence of distant metastasis or metastatic lymph node (M1) involvement (para-aortic, coeliac or para-colic)
* Good performance status Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
* At least 6 months of observation time during which the patient should be treated by chemotherapy and radiation (hyperfractioned 30-50 Gy) with response or stable disease before listing for LT. Patients with PSC and significant liver dysfunction that restricts the tolerability of chemoradiotherapy may be considered on an individual basis
Exclusion Criteria:
* Radiological signs of tumor invasion along intended resection borders
* Direct tumor invasion of the pancreatic head
* Signs of spread to the para-aortic, superior mesenteric, or coeliac lymph nodes
* Perforation of the visceral peritoneum
* Weight loss \>10% in the last six months
* Patient BMI \> 30 kg/m2
* Other malignancies, except curatively treated basal cell carcinoma or other tumors with disease-free interval \> five years without relapse. The final decision on acceptable previous cancer diagnoses is at the principal investigator's discretion.
* Known history of human immunodeficiency virus (HIV) infection
* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Known hypersensitivity to rapamycin
* Prior metastatic disease
* Women who are pregnant or breastfeeding
* Any reason why, in the opinion of the investigator, the patient should not participate
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