NCT01775267终止2 期
ASSOCIATING LIVER PARTITION WITH PORTAL VEIN LIGATION FOR STAGED HEPATECTOMY (ALPPS) Versus Conventional Portal Vein Occlusion (PVO) for Resection of Liver Tumors Unresectable in One Step - a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
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.
- Trial with surgical intervention
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
- None
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
- •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.
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.
研究组 & 干预措施
ALPPS
Experimental
Patients undergo Liver partition and portal vein ligation to induce hypertrophy of the future liver remnant
干预措施: Associating liver partition and portal vein ligation for staged hepatectomy (Procedure)
PVO
Active Comparator
Patient undergo portal vein embolization or ligation
干预措施: Portal vein embolization or ligation (Procedure)
结局指标
主要结局
Liver free of tumors [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
时间窗: 2012 to 2015
次要结局
- rate of hypertrophy over time(2012 to 2015)
- Complications of treatment(2012-2015)
- Postoperative liver and renal function(2012 to 2015)
- Progression of disease(2012-2015)
研究者
研究点 (3)
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