Living donor liver transplantation for unresectable perihilar cholangiocarcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1070220052

Enrollment

Registered

2022-09-13

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perihilar cholangiocarcinoma

Interventions

Living donor liver transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
3-year overall survival after living donor liver transplantation for unresectable (includes borderline resectable) perihilar cholangiocarcinoma	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMegumi Miyahara

Kumamoto University Hospital

byi-senshin@jimu.kumamoto-u.ac.jp+81-96-373-5966

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026