Prevention of Postoperative Pancreatic Fistula by SOMATOSTATIN Compared to OCTREOTIDE: Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 655
- 试验地点
- 2
- 主要终点
- ≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
研究概览
简要总结
The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula
详细描述
Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results.
Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection.
In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention.
Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men or women aged 18 years or greater
- •Signed informed consent
- •Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy
排除标准
- •Patient with radiation therapy
- •Patient with neoadjuvant chemotherapy within 4 weeks before surgery
- •Pregnancy
- •Breastfeeding
- •Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
- •Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
- •Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations
- •Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
- •Patients treated by ciclosporin
- •Patient without health insurance or social security
- •Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
研究组 & 干预措施
Somatostatin
Continuous intravenous infusion of somatostatin-14, 6 mg per day during 6.5 days
干预措施: Somatostatin (Drug)
Octreotide
Subcutaneous octreotide 100 μg 3 times a day for 6.5 days.
干预措施: Octreotide (Drug)
结局指标
主要结局
≥ grade B or C postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula (ISGPF) classification
时间窗: 90 days
次要结局
- Overall pancreatic fistula rate (grade A,B and C)(90 days)
- Overall pancreatic fistula rate (grade B and C)(90 days)
- Overall complication rate (grade 1 to 5)(90 days)
- Severe complication rate (grade 3 to 5)(90 days)
- Mortality (grade 5)(90 days)
- Overall duration of drainage(90 days)
- Cost effectiveness(90 days)
- Overall length of stay(90 days)
- Fistula according to possible new definition of the ISGPF group(90 days)
- ≥grade 3 pancreatic complication rates (fistula, leak, and abscess)(60 days)
- Re-admission rate(90 days)
- Postoperative quality of life after pancreatic surgery(7 days after surgery)