A Multicenter Mayo-initiated Randomized Controlled Trial Comparing Pancreatic Leaks After TissueLink vs SEAMGUARD After Distal Pancreatectomy (PLATS)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation
研究概览
简要总结
The purpose of this research study is to find a lowest leak rate following a distal pancreatectomy (removal of the left side of the pancreas). Distal pancreatectomy is known to have a risk of pancreatic leaks (leakage of pancreatic fluid from the cut surface of the pancreas). Two FDA cleared devices (TissueLink and SEAMGUARD) will be studied to treat and prevent leaks at the end of the pancreas.
详细描述
The objective of this trial is to compare the effectiveness of TissueLink closure of pancreatic stump after distal pancreatectomy to that of SEAMGUARD reinforced stapler closure.
Distal pancreatectomy is performed for a broad variety of indications including benign and malignant conditions. Specifically, distal pancreatectomy refers to resection of the portion of pancreas to the left of the superior mesenteric vein/portal vein trunk, excluding the duodenum and distal bile duct. Pancreatic duct leak at the resection margin is one of the most common complications of distal pancreatectomy. This complication prolongs in-patient and outpatient care and resulting in significant detriments to the patient's operative experience and increases in the financial burden of pancreatic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age equal or above 18 years
- •Accepted for elective distal pancreatectomy for any indication
- •Exclusion from randomization process:
- •Thickness of pancreas on preoperative CT scan images > 2.5 cm at the site of expected transection in anterior-posterior diameter. This will be reviewed by the surgeon the day before the surgeon sees the patient to predetermine the appropriateness of the patient for the study.
- •General study
排除标准
- •Current immunosuppressive therapy
- •Chemotherapy within 2 weeks before operation
- •Bevacizumab (Avastin™) treatment not completed at least 6 weeks before operation
- •Radiotherapy before operation
- •Inability to follow the instructions given by the investigator
- •Lack of compliance
- •Persons unable or unwilling to give informed consent to participate in this study
- •Pregnant women
- •Institutionalized individuals
研究组 & 干预措施
SEAMGUARD with bioabsorbable staple
In this arm pancreatic transection will be executed using an endoscopic linear stapling device. The individual staple depth can be chosen by the operating surgeon. Bioabsorbable Mesh sleeves specifically manufactured for the chosen staple depth and cartridge length will be placed over the stapler before firing.
干预措施: SEAMGUARD with bioabsorbable staple (Device)
TissueLink with radiofrequency ablation
After pancreatic transection, with any method chosen by the operating surgeon, the pancreatic remnant will be treated with TissueLink alone for an ablation depth (thickness) of approximately 7 mm using electrosurgical generator settings of 100 W and a saline drip rate of 1-2 drops per second.
干预措施: TissueLink with radiofrequency ablation (Procedure)
结局指标
主要结局
Percentage of Subjects Who Developed a Postoperative Pancreatic Duct Leak at the Resection Margin (Pancreatic Fistula) Within 90 Days From the Operation
时间窗: 90 days from the operation
Pancreatic fistula was defined as amylase-rich (greater than 3 times upper limit of normal serum amylase for the treating institution) fluid either in the operatively placed drain or upon reinsertion of an image-guided drain for postoperative fluid collection.
次要结局
- Severity of the Pancreatic Fistula Leaks(90 days post operative)