NCT01722175撤回2 期
Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) Versus Portal Vein Occlusion (PVO) to Induce Liver Regeneration for Resection of Liver Tumors That Are Unresectable in One Step - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Liver free of tumors
研究概览
简要总结
This randomized phase II trial compares how well associating liver partition with portal vein ligation for staged hepatectomy (ALPPS) or portal vein occlusion (PVO) works in treating patients with liver cancer. Both treatments are types of 2-stage hepatectomies for removing liver cancer. ALPPS may be more effective than PVO in patients whose disease would traditionally be considered inoperable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient may have primary or secondary hepatic malignancies with a FLR/TLV < 30% or a FLR/BW ratio of < 0.5 for patients with normal liver function (defined as normal transaminases, normal bilirubin, normal factor V, and normal PT/INR). In case of injury due to chemotherapy, known high grade steatosis, or cholestasis > 50 mmol/L, patient may be enrolled into the trial if FLR/TLV is < 40% or FLR/BW ratio < 0.
- •Patient must have extensive liver tumors that would require portal vein embolization or a two-stage hepatectomy and portal vein embolization or ligation by the judgment of surgeons in the tumor board.
- •Patient may have extrahepatic disease as long as it may be addressed after liver surgery and there is a tumor board decision to proceed with liver resection (mostly applicable to CRC metastases).
- •Patient may have received previous chemotherapy.
- •In cases of cholestasis, preoperative drainage procedures (PTC or ERCP) are left up to judgement of physicians.
- •Patient must be ≥ 18 years of age. The patient population over 65 years old needs to be carefully included based on comorbidities.
- •Patient may have undergone previous liver resection.
- •Patient's location must be such that proper staging and follow-up may be performed.
- •Patient's case must be presented at the Multidisciplinary Meeting attended by hepatobiliary surgeons, oncologists, hepatologists, and radiologists, or must be approved directly by Dr. Strasberg or Dr. Chapman.
- •Patient must be able to understand and willing to sign a written informed consent document.
排除标准
- •Patient must not have any significant concomitant diseases rendering him/her unsuitable for major liver surgery by the judgment of the physicians involved, especially if the patient is > 65 years old.
- •Patient must not have enrolled into a clinical trial within 4 weeks of study entry.
- •Patient must not have peritoneal carcinomatosis or other extensive extrahepatic disease.
- •Patient must not have advanced stages of carcinoma of the gallbladder (T3/T4)
- •Patient must not have issues such as drug and/or alcohol abuse.
- •Patient must not need major extrahepatic surgery (e.g. pancreas resection, gastric resection, rectal surgery) within 3 months of study entry.
- •Patient must not be a candidate for liver transplantation in case of HCC.
- •Patient must not be pregnant or breastfeeding. If a female of childbearing potential, patient must have a negative pregnancy test within 14 days of enrollment.
- •Inclusion of Women and Minorities
- •Both men and women and members of all races and ethnic groups are eligible for this trial.
结局指标
主要结局
Liver free of tumors
时间窗: At 3 months
Assessed by two independent and blinded radiologists using dynamic MRI with liver specific contrast; proportion of patients in each treatment arm; incidence across two arms will be summarized using contingency tables and compared by 2-sample Chi-square test or Fisher's exact test.
次要结局
- Disease-free survival(Up to 3 years)
- Incidence of complications(3 months)
- Liver volumetric change after step 1 of ALPPS or PVO(8 weeks)
- Overall survival(Up to 3 years)
- Liver synthetic and transport function(3 months)
研究者
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