JPRN-jRCT1031220705招募中3 期
JCOG2202: Randomized phase III trial of laparoscopic versus open distal pancreatectomy for pancreatic cancer - LAPAN study
akamura Masafumi0 个研究点目标入组 370 人开始时间: 2023年3月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •(1) Pancreatic tumor diagnosed by contrast-enhanced abdominal computed tomography (CT) meeting either one of the following conditions.
- •(i) Histologically proven invasive ductal carcinoma (adenocarcinoma or adenosquamous carcinoma)
- •(ii) Cytologically proven Class IV or Class V
- •In case of the following conditions, pancreatic tumor radiologically compatible with invasive ductal carcinoma is eligible without pathological diagnosis.
- •(a) No neoadjuvant chemotherapy
- •(b) Endoscopic ultrasound-guided tissue acquisition or endoscopic retrograde cholangiopancreatography can not be performed safely.
- •(2) Tumor located in the body or tail of the pancreas.
- •(3) Resectable pancreatic cancer by contrast-enhanced CT. Patients treated with preoperative chemotherapy fulfill both (i) and (ii).
- •(i) Resectable pancreatic cancer before chemotherapy.
- •(ii) Resectable pancreatic cancer after chemotherapy.
- •(4) Muximum length of the tumor <= 8 cm.
- •(5) Curative resection is possible by distal pancreatectomy with regional lymph node dissection.
- •(6) In case of the preceding diagnostic laparoscopy, peritoneal cytology is negative.
- •(7) No invasion to the portal vein or other organs except for the adrenal gland or spleen.
- •(8) Aged between18 and 85 years old.
- •(9) Performance status (ECOG) of 0 or 1.
- •(10) No prior treatment of radiation therapy against pancreatic cancer.
- •(11) No history of upper abdominal surgery except for laparoscopic cholecystectomy.
- •(12) Sufficient organ functions.
- •(13) Written informed consent.
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies.
- •(2) Infectious disease that requires systemic treatment.
- •(3) Body temperature of 38.0 degrees Celsius or higher.
- •(4) During pregnancy, within 28 days of postparturition, or during lactation.
- •(5) Severe mental disease.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressive treatment.
- •(7) Severe comorbidities (such as heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, intestinal obstruction, and poorly controlled hypertension).
- •(8) History of unstable angina pectoris within3 weeks or myocardial infarction within 6 months before registration.
- •(9) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema diagnosed by chest X-ray.
- •(10) Iodide is not allowed because of allergy, renal failure, or bronchial asthma.
研究者
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