Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
Primary Purpose
Pancreatic Neoplasms, Bile Duct Neoplasms, Ampullary Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Billroth-II-type reconstruction
Isolated Roux-en-Y type reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y
Eligibility Criteria
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
Sites / Locations
- Wakayama Medical University , Second Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Billroth-II-type
Isolated Roux-en-Y
Arm Description
Billroth-II-type reconstruction after pancreaticoduodenectomy
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
Outcomes
Primary Outcome Measures
the incidence of pancreatic fistula
Secondary Outcome Measures
the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess
Full Information
NCT ID
NCT00915863
First Posted
May 22, 2009
Last Updated
January 25, 2010
Sponsor
Wakayama Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00915863
Brief Title
Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
Official Title
A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Wakayama Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms, Bile Duct Neoplasms, Ampullary Neoplasms, Duodenal Neoplasms, Pancreatitis
Keywords
pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Billroth-II-type
Arm Type
Active Comparator
Arm Description
Billroth-II-type reconstruction after pancreaticoduodenectomy
Arm Title
Isolated Roux-en-Y
Arm Type
Experimental
Arm Description
Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
Billroth-II-type reconstruction
Other Intervention Name(s)
Child reconstruction
Intervention Description
surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Isolated Roux-en-Y type reconstruction
Other Intervention Name(s)
Roux-en-Y reconstruction
Intervention Description
surgical procedure
Primary Outcome Measure Information:
Title
the incidence of pancreatic fistula
Time Frame
3 months after operation
Secondary Outcome Measure Information:
Title
the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess
Time Frame
3 months after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroki Yamaue, MD
Phone
81-73-441-0612
Email
yamaue-h@wakayama-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaji Tani, MD
Organizational Affiliation
Wakayama Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wakayama Medical University , Second Department of Surgery
City
811-1 Kimiidera, Wakayama
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Yamaue, MD
Phone
+81-73-441-0612
Email
yamaue-h@wakayama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Masaji Tani, MD
Phone
+81-73-441-0613
Email
matani@wakayama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Masaji Tani, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16794381
Citation
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.
Results Reference
background
PubMed Identifier
16615151
Citation
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.
Results Reference
background
PubMed Identifier
16495694
Citation
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.
Results Reference
background
PubMed Identifier
15592915
Citation
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.
Results Reference
background
PubMed Identifier
15951940
Citation
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.
Results Reference
background
PubMed Identifier
30507039
Citation
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.
Results Reference
derived
PubMed Identifier
24975853
Citation
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.
Results Reference
derived
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Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
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