Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
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|ClinicalTrials.gov Identifier: NCT00915863|
Recruitment Status : Unknown
Verified January 2010 by Wakayama Medical University.
Recruitment status was: Recruiting
First Posted : June 8, 2009
Last Update Posted : January 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Bile Duct Neoplasms Ampullary Neoplasms Duodenal Neoplasms Pancreatitis||Procedure: Billroth-II-type reconstruction Procedure: Isolated Roux-en-Y type reconstruction||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||March 2014|
Active Comparator: Billroth-II-type
Billroth-II-type reconstruction after pancreaticoduodenectomy
Procedure: Billroth-II-type reconstruction
Other Name: Child reconstruction
Experimental: Isolated Roux-en-Y
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
Procedure: Isolated Roux-en-Y type reconstruction
Other Name: Roux-en-Y reconstruction
- the incidence of pancreatic fistula [ Time Frame: 3 months after operation ]
- the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess [ Time Frame: 3 months after operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915863
|Contact: Hiroki Yamaue, MDfirstname.lastname@example.org|
|Wakayama Medical University , Second Department of Surgery||Recruiting|
|811-1 Kimiidera, Wakayama, Wakayama, Japan, 641-8510|
|Contact: Hiroki Yamaue, MD +81-73-441-0612 email@example.com|
|Contact: Masaji Tani, MD +81-73-441-0613 firstname.lastname@example.org|
|Principal Investigator: Masaji Tani, MD|
|Study Chair:||Masaji Tani, MD||Wakayama Medical University|