NCT04791735进行中（未招募）不适用
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 33
- 主要终点
- The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
研究概览
简要总结
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
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
- •Male or female patient aged ≥ 18 years
- •Presenting with solitary or multifocal resectable HCC
- •Qualifying for both pure laparoscopic and open approaches
排除标准
- •Physical or psychological status contraindicating the participation to the study
- •Contraindication to surgery
- •Contraindication to pneumoperitoneum
- •ASA (American Society of Anesthesiologists) score IV-V
- •Life expectancy < 2 months
- •Suspicion of mixed type tumor (Hepatocholangiocarcinoma) and fibrolamellar HCC
- •Child-Pugh score > B7
- •Extra-hepatic involvement
- •Liver resection requiring an associated vascular or biliary reconstruction
- •Pregnancy and breast-feeding
- •Tutorship, trusteeship
- •Concurrent participation in other experimental trials concerning the same objective within 90 days following intervention
- •No Affiliation to the French social security
- •No Ability to give their consent and not written informed consent
结局指标
主要结局
The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
时间窗: 90 days after inclusion
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
次要结局
- Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively(90 days after inclusion)
- Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- All-cause mortality (grade 5 according to the Dindo-Clavien classification or a CCI of 100) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Occurrence of postoperative pulmonary complications (pleural effusion, respiratory insufficiency, acute respiratory distress syndrome, pulmonary embolism) within 90 days postoperatively or at any time during hospitalization.(90 days after inclusion)
- Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.(day of surgery, 1, 2, 3, 5 and 7 days after surgery)
- Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90(1, 3, 5, 7, 30, 60, 90 days after inclusion)
- Mean surgical margin widths (in millimeters).(inclusion)
- Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.(inclusion)
- Percentage of patients recurring within 2 years following liver resection.(inclusion)
- Overall and disease free survivals.(60 month)
研究者
研究点 (33)
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