Living donor liver transplantation for unresectable perihilar cholangiocarcinoma

JRCT ID: jRCT1070220052

Registered date:13/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Perihilar cholangiocarcinoma
• Date of first enrollment: 01/09/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Living donor liver transplantation

Outcome(s)

• Primary Outcome: 3-year overall survival after living donor liver transplantation for unresectable (includes borderline resectable) perihilar cholangiocarcinoma

Secondary Outcome

a. Short-term outcomes after living donor liver transplantation (LDLT): operative time, estimated blood loss, postoperative complications, in-hospital mortality
b. Recurrence rate/pattern and treatment(s) for recurrence
c. Other adverse events besides recurrence and their treatments
d. 3-year recurrence-free overall survival and 3-year graft survival after LDLT
e. Efficacy and safety of neoadjuvant therapy
f. Number of patients who did not undergo LDLT, treatment(s) and response, and 3-year overall survival study inclusion

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. Unresectable disease but with no extrahepatic metastases and remains progression-free for 3 months or more under neoadjuvant Tx
i. Poor hepatic reserve (future liver remnant less than 40%, ICG-R15 10% or more, or ICG-K less than 0.05)
ii. Inability to resume portal vein/arterial inflow due to extensive vascular invasion
iii. Extensive longitudinal spread along the biliary tree precluding R0 resection
iv. Cholangiocarcinoma arising in the setting of PSC with poorly-defined localization

2. Conditions fit for living donor liver transplantation
a)Age, 15-69
b)ECOG performance status, 0 or 1
c)Laboratory data that meet the following:
i.Neutrophil: 1,500/microliter or more
ii.Platelet: 30,000/microliter or more
iii.Hb: 7.5g/dL or more
iv.Cr: 1.5mg/dL or more
v.New York Heart Association (NYHA) classes I and II
vi.Hugh-Jones classes I and II
d)Documented informed consent from the participant

Exclude criteria

1. Presence of intra and extrahepatic metastases
2. Presence of Lymph node metastases
3. Malignancies other than perihilar cholangiocarcinoma
4. Presence of uncontrolled infection
5. Adverse events Grade 4 or more (CTCAE v5.0) due to neoadjuvant therapy
6. Other conditions that are clinically unfit for the study

Related Information

• Primary Sponsor: Hibi Taizo