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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

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 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

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
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

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
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
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:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases