Colorectal Metastasis to Liver Extraction With Auxiliary Transplant and Delayed Resection Registry Study
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Graft and Patient Survival Outcomes
概览
简要总结
Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).
详细描述
The CLEAR protocol will evaluate the feasibility of RAPID for LT recipients with CRLM and compare important post-transplant outcomes after RAPID with conventional LT approaches. We expect that the findings from this innovative protocol will transform the current approach to patients with CRLMs by expanding donor organ supply and offering a widely available, life-saving treatment to a large cohort of patients with no options other than palliative chemotherapy at the present time.
Aim 1:
We will compare graft and patient survival in LT recipients transplanted with the RAPID technique (intervention group) versus conventional LT methods (control group).
Hypothesis
We hypothesize that RAPID LT for CRLMs will demonstrate acceptable and comparable post-transplant outcomes to conventional living donor LT and deceased donor LT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).
- •Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.
排除标准
- •Adults unable to consent
- •Pregnant Women
- •Certain clinical/surgical/anatomical parameters, at the discretion of the PI.
研究组 & 干预措施
Living Donor Liver Transplant
Living Donor Liver Transplant using right or left lobe donor graft
RAPID Living Donor Liver Transplant (using LLS or left lobe)
Resection And Partial Liver Transplantation with Delayed Total Hepatectomy is a two staged procedure that utilized partial donor grafts and stages hepatectomies. In the first stage, a left hepatectomy is performed and a LT is performed using a donor left lateral segment split (LLS) (or left lobe split in some circumstances). Once the LT has achieved sufficient volume (typically within two weeks), a right hepatectomy is performed to remove all native liver, leaving the LT intact.
RAPID Deceased Donor Liver Transplant (LLS or left lobe)
Resection And Partial Liver Transplantation with Delayed Total Hepatectomy is a two staged procedure that utilized partial donor grafts and stages hepatectomies. In the first stage, a left hepatectomy is performed and a LT is performed using a donor left lateral segment split (LLS) (or left lobe split in some circumstances). Once the LT has achieved sufficient volume (typically within two weeks), a right hepatectomy is performed to remove all native liver, leaving the LT intact.
Liver Transplant Deceased Donor (Whole Liver)
The whole of the deceased donor liver is used. Livers from deceased donors are allocated to potential recipients according to the MELD (Model for End-Stage Liver Disease) scoring system.
结局指标
主要结局
Graft and Patient Survival Outcomes
时间窗: From liver transplant to 12 months
Graft survival will be measured as the time from transplantation to graft failure, or re-transplantation date.
次要结局
- Outcomes of liver transplant recipients(From liver transplant to 12 months)
研究者
Zachary Dietch
Assistant Professor, Surgery (Organ Transplant)
Northwestern University