Orthotopic Liver Transplantation Using a Living Donor Into An Adult Recipient
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies.
研究概览
简要总结
The purpose of this study is to:
determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft for living donor liver transplantation.
study the regeneration of liver tissue by volumetric testing for both donor and recipient.
assess if graft and patient survival with living donor transplantation is comparable to that of cadaveric donor transplantation.
详细描述
Preoperative Evaluation of Recipients:
Recipients who consent for living donor liver transplantation will have the following measurements performed in addition to those normally performed in their pretransplant workup.
- Ideal, dry and current body weights.
- An estimation of the recipient's actual liver volume will be determined by linear CT scanning. Continuous axial-10 mm-thick slices will be obtained following IV contrast. The area of the liver will be electronically outlined on the CT console and then multiplied by the slice thickness. This measurement will be used to assess the accuracy of CT in predicting liver weight and volume by comparing it to the actual volume displacement and weight following hepatectomy.
- The expected ideal volume of the recipient liver will be calculated from the patient's body weight. Standard liver volume (ml) = 706.2 x (body surface area [m2] + 2.4. Body surface area is calculated from the following formula: BSA = Square root of (Height [inches] x Weight [lbs.]/3131). Example: A recipient who is 5'4" and weighs 121 lbs. has a body surface area of 1.58m2. Thus the estimated ideal liver volume for this recipient is 1120 cc. In order to provide adequate hepatic parenchyma for function they would require 35%-40% of this volume = 392 - 447 cc of liver tissue.
Donor Evaluation:
- Actual and ideal body weight.
- History and physical exam.
- Psychosocial evaluation of the donor will be performed by a social worker for the kidney transplant program. Since he is not affiliated with the liver program, he will be able to objectively assess the potential donor's psychosocial condition. He will continue to see the patient (donor) after the operation while hospitalized and as an outpatient once and then on a prn basis.
- Evaluations by a donor advocate physician who is not part of the transplant department. The potential donor will be interviewed alone by the physician and allowed to express reservations concerning the procedure in private. The donor advocate physician will review the donor workup in detail to ensure its appropriateness. Should the donor advocate physician indicate that the donor is unsuitable, the donor will be excluded from further evaluation.
- Donor must be in usual state of health, with normal liver function and no major pre-existing medical conditions.
- Laboratory testing to rule out concomitant disease that would exclude donation would include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No current or prior history of heart, lung or other medical problems.
- •No history of liver disease.
- •No history of malignancy, except limited basal cell carcinoma.
- •ABO / HLA compatibility with the recipient.
- •If female and premenopausal, a negative pregnancy test.
- •Related to recipient either by blood or marriage and having a stable, long term, emotional relationship.
- •The donor's body size and volumetric determination of liver mass by abdominal CT scan will indicate whether or not a donor is a suitable candidate for liver donation if the donor meets the other inclusion criteria. Favorable donors for the individual organs will be those with donor graft to recipient body dry weight ratios (GRBWR) of >0.7% and those with a ratio of graft volume to recipient's expected liver volume (GWRLW) of >35%.
- •Satisfactory psychosocial evaluation. -
排除标准
- •Recipient Exclusion Criteria:
- •Pregnant or nursing females.
- •Patients with significant concomitant infections.
- •Patients who require multiple organ transplants.
- •Significant pulmonary disease. If pulmonary disease is clinically suspected, diagnostic studies will be performed to exclude the presence of pulmonary hypertension (PA systolic pressure >40 mm Hg) or arterial saturation (Po2<60 mmHg, breathing room air).
- •Patients at a higher than average perioperative risk secondary to severe decompensated liver disease or previous surgery (i.e., re-transplantation) or infections.
结局指标
主要结局
The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies.
时间窗: post transplant
The primary outcome for recipients will be the assessment of patient and graft survival. Comparison to results of contemporaneous, non-randomized cadaver donor transplants will be made.
时间窗: post transplant
次要结局
未报告次要终点
