A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Rate of postoperative complications
研究概览
简要总结
The purpose of this study is to determine the feasibility of surgical techniques involving minimal entry into the living body approach for tumor reduction and treatment in which highly concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and to determine if this approach may improve short-term postoperative outcomes, including the development of complications related to surgery within the first 30 days after surgery.
Participation in this study is entirely voluntary. Approximately 30 subjects will take part in this single-center study and all will be enrolled at University of California San Diego.
详细描述
Potential patients will be prospectively identified prior to the time of operation based on the inclusion/exclusion criteria . Those who meet the eligibility criteria and sign consent will undergo laparoscopy. During laparoscopy, the peritoneal cancer index (PCI) will be determined for all patients. The PCI is a scoring system that was developed to standardize the assessment of disease burden. PCI is determined by assigning a Lesion size score (LSS) to each of the 13 peritoneal regions and then summing the scores (defined further below). Those with a PCI of ≤10 will continue with laparoscopic cytoreduction and HIPEC. Patients with a PCI of >10 will have an open cytoreduction and HIPEC. The Investigators plan to enroll 30 patients, though the investigators estimate 18 will ultimately undergo laparoscopic cytoreduction and HIPEC.
Trial Design:
- Stage 1 will enroll 9 patients, and if 2 or less patients experience postoperative complications within 30 days of HIPEC the investigators will proceed to stage 2. If 3 or more patients experience postoperative complications the investigators will terminate the trial early secondary to futility.
- Stage 2 will enroll 9 additional patients, and if the investigators have 4 or less patients with postoperative complications out of the total 18 patients the investigators will reject the null hypothesis.
Visit 1- screening
- History and physical examination
- Routine blood tests standard for monitoring of patient's disease include a complete blood count, kidney and liver chemistries, and tumor markers (CEA and carbohydrate antigen 19-9 (CA19-9)) if not already performed;
- Imaging tests per standard of care (chest x-ray, CT scan; PET Scan); possibly laparoscopy or colonoscopy (both scan patients abdomen area); if not performed prior to consultation at University of California, San Diego (UCSD)
- Electrocardiogram (ECG); thallium heart scan or echocardiogram if history of cardiac disease (prior Myocardial Infarction, Congestive Heart Failure, angina, cardiomyopathy, vascular dysfunction and arrhythmia)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged > 18 years old
- •Capable of providing informed consent.
- •Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases.
- •Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings.
- •Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-
- •Patients who are medically fit for surgery defined as the following:
- •No parenchymal hepatic metastases
- •No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction
- •No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
- •No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
- •Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3
- •An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible).
- •Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome);
- •Alkaline phosphatase < 2.5 times the upper limit of normal; and/or
- •Aspartate transaminase (AST) < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)
- •Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits
- •Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery).
- •No clinical history of acute myocardial infarction within six months of registration.
- •Patients who are status post revascularization procedures with satisfactory cardiac function are eligible.
- •No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease.
- •No concurrent second malignancy requiring systemic therapy.
- •No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements.
排除标准
- •Peritoneal carcinomatosis index (PCI) > 10
- •Systemic (extraperitoneal) disease, pregnant, incarcerated.
- •Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy.
结局指标
主要结局
Rate of postoperative complications
时间窗: within 30 days of surgery
Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.
次要结局
未报告次要终点
研究者
Dr. Kaitlyn J Kelly
Assistant Clinical Professor of Surgery
University of California, San Diego