Liver Transplantation for Non-resectable Perihilar Cholangiocarcinoma: a Prospective Exploratory Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study will investigate whether liver transplantation provides increased survival, low side effects and good quality of life in patients with bile duct cancer where the tumor cannot be removed by normal surgery. Analyzes of blood and tissue samples from the tumor will be investigated to see if the analyzes can indicate who may have recurrence of the disease after liver transplantation. Furthermore, the effect of chemotherapy on normal liver and tumor tissues in the liver that are removed during transplantation will be investigated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Radiologically strong suspicion of pCCA

• Tumor can involve intrahepatic portal vein without thrombosis of extrahepatic portal vein

• Tumor can involve hepatic artery distal to gastroduodenal artery or involve replaced hepatic artery

• First time pCCA

• Disease deemed not eligible for liver resection based on tumor location or underlying liver dysfunction

• No extrahepatic disease, or lymph node involvement detected on imaging

• No signs of extrahepatic metastatic disease according to PET-CT scan

• No signs of extrahepatic metastatic disease according to CT or MR (chest/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit

• At least 18 years of age

• Good performance status, Eastern Cooperative Oncology Group (ECOG) score: 0 or 1

• Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>50, Bilirubin\<3 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.5 x upper normal level. Albumin above lower normal level, Normal IgG4 levels

• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations

• Received chemotherapy for at least 6 months with at least 10% response according ti RECIST criteria and with no progression of disease at time of Lt

• At least 10 months from diagnosis

• Patient must be accepted for transplantation before progressive disease

• Twelve months or more time span from the diagnosis of pCCA and date of being listed for liver transplantation

Locations
Other Locations
Norway
Oslo university hospital
RECRUITING
Oslo
Contact Information
Primary
Sheraz Yaqub, MD PhD
shya@ous-hf.no
+4723073296
Backup
Pål-Dag Line, MD PhD
pline@ous-hf.no
+4723070509
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2045-05-31
Participants
Target number of participants: 15
Treatments
Experimental: Liver transplant
The patients will be transplanted according to standard procedures by the institutional protocol. Median time of surgery is 7 hours and 20 minutes. Each surgical procedure will be performed by specialists at the Rikshospitalet liver transplantation team, which consists of seven specialists at the unit. The transplantation procedure is initiated by an exploratory laparotomy with clinical assessment and frozen section of the lymphnodes in the hepatoduodenal ligament and along the common hepatic artery/coeliac axis. Complete clearance of the lymphatic tissue around the hepatoduodenal ligament. Frozen section is obtained from the distal end of the common bile duct. Evidence of disease dissemination to these regional lymph nodes will be an absolute contraindication to transplantation.
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov