Standardization of Surgery on the Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00679913
First received: May 15, 2008
Last updated: May 8, 2014
Last verified: May 2014
  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:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Survival [ Time Frame: 2 year after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 244
Study Start Date: November 2005
Study Completion Date: December 2013
Primary Completion Date: December 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
Study First Received: May 15, 2008
Results First Received: April 7, 2014
Last Updated: May 8, 2014
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 July 23, 2014