Standardization of Surgery on the Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standard pancreatoduodenectomy
Extended pancreatoduodenectomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Pancreaticoduodenectomy, Extended lymphadenectomy
Eligibility Criteria
Inclusion Criteria:
- Age : 20- 85 years old
- No evidence of metastasis and to be possible to resect radically
- No history of previous radiation therapy or chemotherapy
- Pathological diagnosis: adenocarcinoma of pancreas
- Patients who agree and sign the informed consent
- More than 70 in Karnofsky performance scale
Exclusion Criteria:
- Past medical history of treatment for other malignant disease
- Recurred pancreatic cancer patients
- Patients with R1/R2 resection
- Patients who underwent neoadjuvant chemotherapy
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
standard pancreatoduodenectomy
extended pancreatoduodenectomy
Outcomes
Primary Outcome Measures
Survival
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
Secondary Outcome Measures
Morbidity
Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy
Full Information
NCT ID
NCT00679913
First Posted
May 15, 2008
Last Updated
May 8, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00679913
Brief Title
Standardization of Surgery on the Pancreatic Cancer
Official Title
Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.
Detailed Description
In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Pancreaticoduodenectomy, Extended lymphadenectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
standard pancreatoduodenectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
extended pancreatoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
Standard pancreatoduodenectomy
Intervention Description
Standard pancreatoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
Extended pancreatoduodenectomy
Other Intervention Name(s)
Extended lymphadenectomy
Intervention Description
Extended pancreatoduodenectomy
Primary Outcome Measure Information:
Title
Survival
Description
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
Time Frame
2 year after surgery
Secondary Outcome Measure Information:
Title
Morbidity
Description
Number of participants with morbidity, such as bleeding, sepsis, pancreatic fistula, intra-abdominal abscess, wound infection, delayed gastric emptying, and diarrhea after standard and extended pancreaticoduodenectomy
Time Frame
within 2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age : 20- 85 years old
No evidence of metastasis and to be possible to resect radically
No history of previous radiation therapy or chemotherapy
Pathological diagnosis: adenocarcinoma of pancreas
Patients who agree and sign the informed consent
More than 70 in Karnofsky performance scale
Exclusion Criteria:
Past medical history of treatment for other malignant disease
Recurred pancreatic cancer patients
Patients with R1/R2 resection
Patients who underwent neoadjuvant chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Whe Kim, MD., PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
9790340
Citation
Pedrazzoli S, DiCarlo V, Dionigi R, Mosca F, Pederzoli P, Pasquali C, Kloppel G, Dhaene K, Michelassi F. Standard versus extended lymphadenectomy associated with pancreatoduodenectomy in the surgical treatment of adenocarcinoma of the head of the pancreas: a multicenter, prospective, randomized study. Lymphadenectomy Study Group. Ann Surg. 1998 Oct;228(4):508-17. doi: 10.1097/00000658-199810000-00007.
Results Reference
background
PubMed Identifier
10235519
Citation
Yeo CJ, Cameron JL, Sohn TA, Coleman J, Sauter PK, Hruban RH, Pitt HA, Lillemoe KD. Pancreaticoduodenectomy with or without extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma: comparison of morbidity and mortality and short-term outcome. Ann Surg. 1999 May;229(5):613-22; discussion 622-4. doi: 10.1097/00000658-199905000-00003.
Results Reference
background
PubMed Identifier
16269290
Citation
Farnell MB, Pearson RK, Sarr MG, DiMagno EP, Burgart LJ, Dahl TR, Foster N, Sargent DJ; Pancreas Cancer Working Group. A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma. Surgery. 2005 Oct;138(4):618-28; discussion 628-30. doi: 10.1016/j.surg.2005.06.044.
Results Reference
background
PubMed Identifier
17318801
Citation
Michalski CW, Kleeff J, Wente MN, Diener MK, Buchler MW, Friess H. Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg. 2007 Mar;94(3):265-73. doi: 10.1002/bjs.5716.
Results Reference
background
PubMed Identifier
24368638
Citation
Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384.
Results Reference
derived
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Standardization of Surgery on the Pancreatic Cancer
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