Phase I Feasibility Trial To Study The Safety Of Sealing Resected Pancreatic Surfaces After Partial Distal Pancreatectomy Using Laser Tissue Welding
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss
研究概览
简要总结
The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.
The hypothesis is that the laser tissue welding device is safe and effective in sealing the pancreas, thereby decreasing the blood loss (operative and post-operative), and pancreatic juice leakage for patients when the Laser Tissue Welding device is used after pancreatic resection.
详细描述
UNMET CLINICAL NEED
In the United States, pancreatic cancer is the fourth leading cause of cancer-related death in both men and women and will be the second leading case by 2030. Pancreatoduodenectomy (Whipple procedure) and distal partial pancreatectomy is used to treat pancreatic tumors, and these procedures are associated with a high rate of morbidity due to pancreatic fistulae.
As per the Surveillance, Epidemiology and End Results (SEER) Program: It is estimated that 41,609 men and women (21,370 men and 21,770 women) will be diagnosed with and 38,460 men and women will die of cancer of the pancreas in 2013. The five-year survival is dismal, 24.1% for localized malignancy, and drops to 6% if there is regional spread. There are 45,220 new cases in 2013 and 38,460 deaths.
Distal Pancreatectomy may be indicated for malignant exocrine tumors of the body and tail of pancreas (62%), insulinomas, chronic pancreatitis (12%), pancreatic pseudocysts, non pancreatic tumors (23%) and injury due to trauma.
Due to heighten awareness and preventative care, there has been an increase in detection of incidental small pancreatic mass cases due to widespread use of abdominal cross sectional imaging and thus an increase in the amount of pancreatic surgery performed. This is the stage when curative resections may be possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Eligible participants will be 18 years and older of both genders.
- •T1a (≤ 4 cm, as measured by the maximal dimension by CT or MRI). Final determination of disease stage is made during the operation by the investigator. All resectable cystic, benign, primary or secondary malignant tumors.
- •Serum creatinine: ≤ 2.5 mg/dL
- •Glomerular filtration rate greater than ≥ 50 ml/min/m2
- •Platelet count ≥ 50,000/mm3
- •Prothrombin time < 18 seconds
- •PTT not >1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions [e.g., atrial fibrillation]);
- •Serum albumin levels > 3g/dL (Normal range 3.5 to 5 g/dL)
排除标准
- •Age younger than 18 years' old
- •Severe uncorrected hypertension (> 180 systolic and >110 diastolic)
- •Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)
- •Females who are breast feeding who do not switch the infant to formula prior to surgery
- •Active urinary tract infection
- •T1b (>4 cm) lesion and above
- •Systemic or local infection.
- •Subject has known allergy or intolerance to iodine or human serum albumin.
- •Recent febrile illness that precludes or delays participation preoperatively.
- •Treatment with another investigational drug or other intervention during the study and follow-up period.
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
结局指标
主要结局
PRIMARY EFFICACY AS A SEALANT: Intra-operative blood loss
时间窗: Intra-operative
Operative blood loss is defined by: volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use. Clinical drop in hemoglobin (1 gm% = 300 ml) without hemodilution. Correlates with intra-operative blood transfusions. Correlates with post-operative blood transfusions.
次要结局
- SECONDARY SAFETY: Prolonged post-operative pancreatic leakage(30 days)
- SECONDARY SAFETY: Post-operative blood loss requiring return to the operating room(30 days)
- SECONDARY SAFETY: Surgical space abscess(30 days)