Standardization of Surgery on the Pancreatic Cancer - Full Text View

Purpose

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	Intervention	Phase
Pancreatic Cancer	Procedure: Standard pancreatoduodenectomy Procedure: Extended pancreatoduodenectomy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

survival [ Time Frame: 3 year after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

morbidity [ Time Frame: within 3 years after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	216
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2012
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 standard pancreatoduodenectomy	Procedure: Standard pancreatoduodenectomy Standard pancreatoduodenectomy
Active Comparator: 2 extended pancreatoduodenectomy	Procedure: Extended pancreatoduodenectomy Extended pancreatoduodenectomy Other Name: Extended lymphadenectomy

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679913

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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.

Responsible Party:	Sun-Whe Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00679913 History of Changes
Other Study ID Numbers:	H-0509-513-157
Study First Received:	May 15, 2008
Last Updated:	September 14, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Pancreatic cancer
Pancreaticoduodenectomy
Extended lymphadenectomy

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013