Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Time to functional recovery postoperatively
研究概览
简要总结
This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.
详细描述
The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy.
In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach.
This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data.
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 (Participant)
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
- •Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
- •Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
- •Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory.
排除标准
- •Body mass index > 35 kg/m2
- •Pregnancy
- •Previous history of major abdominal surgery
- •Requirement for multivisceral resection (additional surgical resection)
- •Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
- •Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature
结局指标
主要结局
Time to functional recovery postoperatively
时间窗: From date of surgery to date of functional recovery as described, assessed up to 90 days.
Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following: * Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score) * Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired) * Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support * No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.
Time to functional recovery postoperatively
时间窗: From date of surgery to date of functional recovery as described, assessed up to 90 days.
Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following: * Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score) * Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired) * Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support * No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.
次要结局
- Operative time(During surgery)
- Postoperative complication rates and associated interventions(Postoperative Day 1 to Day 30)
- Postoperative mortality(Postoperative Day 1 to Day 90)
- Quality of life measurements(Postoperative Day 1 to Day 90)
- Margin resection status (R) in patients with pancreatic adenocarcinoma(During surgery)
- Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma(During surgery)
- Postoperative recurrence in patients with pancreatic adenocarcinoma(Postoperative Day 1 up to 5 years after surgery)
- Postoperative survival in patients with pancreatic adenocarcinoma(Postoperative Day 1 up to 5 years after surgery)
- Perioperative costs(Postoperative Day 1 to Day 90)
- Intraoperative blood loss(During surgery)
- Intraoperative blood loss(During surgery)
- Operative time(During surgery)
- Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively(Postoperative Day 1 to Day 56)
- Postoperative complication rates and associated interventions(Postoperative Day 1 to Day 30)
- Postoperative mortality(Postoperative Day 1 to Day 90)
- Quality of life measurements(Postoperative Day 1 to Day 90)
- Margin resection status (R) in patients with pancreatic adenocarcinoma(During surgery)
- Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma(During surgery)
- Postoperative recurrence in patients with pancreatic adenocarcinoma(Postoperative Day 1 up to 5 years after surgery)
- Postoperative survival in patients with pancreatic adenocarcinoma(Postoperative Day 1 up to 5 years after surgery)
- Perioperative costs(Postoperative Day 1 to Day 90)
研究者
JIABIN JIN
Attending Surgeon, Pancreatic Disease Center
Ruijin Hospital