Standardization of Surgery on the Pancreatic Cancer
Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
1 other identifier
interventional
244
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pancreatic-cancer
Started Nov 2005
Longer than P75 for phase_3 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 15, 2008
CompletedFirst Posted
Study publicly available on registry
May 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
June 6, 2014
CompletedJune 6, 2014
May 1, 2014
7.1 years
May 15, 2008
April 7, 2014
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
2 year after surgery
Secondary Outcomes (1)
Morbidity
within 2 years after surgery
Study Arms (2)
1
ACTIVE COMPARATORstandard pancreatoduodenectomy
2
ACTIVE COMPARATORextended pancreatoduodenectomy
Interventions
Extended pancreatoduodenectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Past medical history of treatment for other malignant disease
- Recurred pancreatic cancer patients
- Patients with R1/R2 resection
- Patients who underwent neoadjuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (5)
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.
PMID: 9790340BACKGROUNDYeo 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.
PMID: 10235519BACKGROUNDFarnell 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.
PMID: 16269290BACKGROUNDMichalski 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.
PMID: 17318801BACKGROUNDJang 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.
PMID: 24368638DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sun-Whe Kim, M.D., Ph.D., FACS
- Organization
- Seoul National University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Sun-Whe Kim, MD., PhD.
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- LTE60
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 15, 2008
First Posted
May 19, 2008
Study Start
November 1, 2005
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
June 6, 2014
Results First Posted
June 6, 2014
Record last verified: 2014-05