Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059506) titled 'A Prospective Observational Study of Living Donor Liver Transplantation for Liver Metastases from Pancreatic and Gastrointestinal Neuroendocrine Tumors' on Oct. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Liver metastases from pancreatic and gastrointestinal neuroendocrine tumors
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to establish a platform to evaluate the safety and efficacy of living donor liver transplantation for liver metastases from pancreatic and gastrointestinal neuroendocrine tumors.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1 Histologically confirmed pancreatic or gastrointestinal neuroendocrine tumor
2 Presence of synchronous or metachronous liver metastases that are deemed unresectable for one or more of the following reasons, Functionally unresectable, Technically unresectable, Oncologically unresectable
3 Absence of extrahepatic metastases confirmed by somatostatin receptor imaging.
4 Availability of an appropriate living donor candidate.
5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6 Adequate function of major organs
7 Age between 18 and 69 years
Key exclusion criteria - 1. Histologically diagnosed neuroendocrine carcinoma or mixed neuroendocrine-non-neuroendocrine neoplasm.
2. Unknown primary site of the neuroendocrine tumor.
3. Presence of extrahepatic distant metastases.
4. Presence of active double cancers, concurrent malignancies requiring treatment.
5. Presence of active infections requiring treatment.
6. Pregnant or potentially pregnant women.
7. Presence of psychiatric disorders or symptoms that interfere with daily life and are considered to make participation in the study difficult.
8. Any other cases deemed ineligible for living donor liver transplantation under standard clinical practice.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 29 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2036 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068026
Disclaimer: Curated by HT Syndication.