A Phase II Trial of Pre-Operative Endoscopic Botulinum Toxin Injection in the Prevention of Postoperative Pancreatic Fistula Following Distal Pancreatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)
研究概览
简要总结
This phase II trial studies the effect of botulinum toxin (Botox) in preventing postoperative pancreatic fistula after distal pancreatectomy. Postoperative pancreatic fistula (POPF) is a known risk of distal pancreatic surgery, in which leakage of pancreatic digestive liquids causes internal swelling that can be painful (termed inflammation). A valve-like muscle, called the Sphincter of Oddi, opens and closes, controlling the flow of digestive liquids from the liver (bile) and pancreas (pancreatic juice) to the small intestine (duodenum). After surgery, the Sphincter of Oddi may act to block the flow of normal pancreatic secretions, causing secretions to leak into the abdomen resulting in POPF. Botox is a drug that can cause paralysis of muscles. Giving an injection of Botox into the sphincter of Oddi before distal pancreatic surgery may reduce leakage of digestive fluids and potential POPF.
详细描述
PRIMARY OBJECTIVE:
I. Evaluate the efficacy of pre-operative botulinum toxin type A (BTX) injection compared to no therapy for the prevention of clinically relevant POPF.
SECONDARY OBJECTIVES:
I. Evaluate the safety of pre-operative BTX injection into the Sphincter of Oddi.
II. Evaluate the efficacy of pre-operative BTX injection compared to no therapy for the prevention of all POPF.
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
- •Participant scheduled for elective distal pancreatectomy or radical antegrade modular pancreatosplenectomy (RAMPS), via open or laparoscopic technique
- •Participant >= 18 years of age
- •Ability to understand nature and individual consequences of clinical trial
- •Written informed consent from participant or legally authorized representative
- •For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
排除标准
- •Known hypersensitivity to any BTX preparation or to any of the components in the formulation
- •Infection at the proposed injection site, including cholangitis
- •Anatomy incompatible with planned intervention (e.g., Roux-en-Y gastric bypass, distal gastrectomy with Roux-en-Y or Billroth II reconstruction)
- •Acute pancreatitis within 2 weeks of planned study intervention
- •American Society of Anesthesiologists (ASA) score > III
- •Serious cardiovascular disease (e.g., myocardial infarction in the past year, New York Heart Association [NYHA] III/IV congestive heart failure, unstable angina)
- •Creatinine clearance < 30 mL/min
- •Liver cirrhosis (of any Child-Pugh grade)
- •Neuromuscular or any neurological disease with associated increased risk for a participant undergoing BTX injection
- •Prior BTX administration
- •Inability to obtain informed consent due to comprehension or language barrier
- •Inability to comply with study and/or follow-up procedures
- •Pregnancy or lactation
- •Any condition that could result in undue risk for the participant and/or influence outcome measures (in the opinion of the investigator)
研究组 & 干预措施
Treatment of POPF (botulinum toxin type A)
Patients receive botulinum toxin type A via endoscopic injection into intraduodenal sphincter of Oddi segment between 7-14 days prior to planned distal pancreas resection.
干预措施: Botulinum Toxin Type A (Biological)
结局指标
主要结局
Number of Participants With Clinically Relevant Postoperative Pancreatic Fistula (POPF)
时间窗: Up to postoperative day 30
Defined by standard biochemical definitions of POPF per the International Study Group of Pancreatic Fistula (ISGPF) criteria.
次要结局
- Rate of Serious Adverse Event(Prior to surgery up to 30 days post surgery (up to 3 months))
- Number of Participants With Any POPF(Prior to surgery up to 30 days post surgery (up to 3 months))
研究者
Brett C. Sheppard, M.D., FACS
Principal Investigator
OHSU Knight Cancer Institute