Standardization of Surgery on the Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00679913

Recruitment Status : Completed

First Posted : May 19, 2008

Results First Posted : June 6, 2014

Last Update Posted : June 6, 2014

Sponsor:

Information provided by (Responsible Party):

Sun-Whe Kim, Seoul National University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Procedure: Standard pancreatoduodenectomy Procedure: Extended pancreatoduodenectomy	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	244 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
Study Start Date :	November 2005
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatic Cancer

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 standard pancreatoduodenectomy	Procedure: Standard pancreatoduodenectomy Standard pancreatoduodenectomy
Active Comparator: 2 extended pancreatoduodenectomy	Procedure: Extended pancreatoduodenectomy Extended pancreatoduodenectomy Other Name: Extended lymphadenectomy

Outcome Measures

Primary Outcome Measures :

Survival [ Time Frame: 2 year after surgery ]
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery

Secondary Outcome Measures :

Morbidity [ Time Frame: within 2 years after surgery ]
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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT00679913

Locations

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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Principal Investigator:	Sun-Whe Kim, MD., PhD.	Seoul National University Hospital

More Information

Publications:

Pedrazzoli S, DiCarlo V, Dionigi R, Mosca F, Pederzoli P, Pasquali C, Klöppel 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.

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.

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.

Michalski CW, Kleeff J, Wente MN, Diener MK, Büchler 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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Sun-Whe Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00679913
Other Study ID Numbers:	H-0509-513-157
First Posted:	May 19, 2008 Key Record Dates
Results First Posted:	June 6, 2014
Last Update Posted:	June 6, 2014
Last Verified:	May 2014

Keywords provided by Sun-Whe Kim, Seoul National University Hospital:


Pancreatic cancer Pancreaticoduodenectomy Extended lymphadenectomy

Additional relevant MeSH terms:

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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms	Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases

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