Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy
研究概览
地位
详细说明
The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.
Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.
The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Wakayama
-
811-1 Kimiidera, Wakayama、Wakayama、日本、641-8510
- 招聘中
- Wakayama Medical University , Second Department of Surgery
-
接触：
- Hiroki Yamaue, MD
- 电话号码：+81-73-441-0612
- 邮箱：yamaue-h@wakayama-med.ac.jp
-
接触：
- Masaji Tani, MD
- 电话号码：+81-73-441-0613
- 邮箱：matani@wakayama-med.ac.jp
-
首席研究员：
- Masaji Tani, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent
Exclusion Criteria:
- young patients (less than 20-years-old)
- patients with severe complications which were possible to prolong hospital stay
- patients undergone hemodialysis
- patients combined resection of other organs
- patients who were diagnosed inadequacy for this study by a physician
- patients without an informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Billroth-II-type
Billroth-II-type reconstruction after pancreaticoduodenectomy
|
surgical procedure
其他名称：
|
|
实验性的：Isolated Roux-en-Y
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
|
surgical procedure
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
the incidence of pancreatic fistula
大体时间：3 months after operation
|
3 months after operation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess
大体时间：3 months after operation
|
3 months after operation
|
合作者和调查者
调查人员
- 学习椅：Masaji Tani, MD、Wakayama Medical University
出版物和有用的链接
一般刊物
- Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6.
- Tani M, Kawai M, Terasawa H, Ina S, Hirono S, Uchiyama K, Yamaue H. Does postoperative chemotherapy have a survival benefit for patients with pancreatic cancer? J Surg Oncol. 2006 May 1;93(6):485-90. doi: 10.1002/jso.20440.
- Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20. doi: 10.1097/01.sla.0000201479.84934.ca.
- Tani M, Onishi H, Kinoshita H, Kawai M, Ueno M, Hama T, Uchiyama K, Yamaue H. The evaluation of duct-to-mucosal pancreaticojejunostomy in pancreaticoduodenectomy. World J Surg. 2005 Jan;29(1):76-9. doi: 10.1007/s00268-004-7507-0.
- Tani M, Kawai M, Terasawa H, Ueno M, Hama T, Hirono S, Ina S, Uchiyama K, Yamaue H. Complications with reconstruction procedures in pylorus-preserving pancreaticoduodenectomy. World J Surg. 2005 Jul;29(7):881-4. doi: 10.1007/s00268-005-7697-0.
- Busquets J, Martin S, Fabregat J, Secanella L, Pelaez N, Ramos E. Randomized trial of two types of gastrojejunostomy after pancreatoduodenectomy and risk of delayed gastric emptying (PAUDA trial). Br J Surg. 2019 Jan;106(1):46-54. doi: 10.1002/bjs.11023. Epub 2018 Dec 3.
- Tani M, Kawai M, Hirono S, Okada KI, Miyazawa M, Shimizu A, Kitahata Y, Yamaue H. Randomized clinical trial of isolated Roux-en-Y versus conventional reconstruction after pancreaticoduodenectomy. Br J Surg. 2014 Aug;101(9):1084-91. doi: 10.1002/bjs.9544. Epub 2014 Jun 26.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.