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

May 15, 2008
May 8, 2014
November 2005
December 2012   (final data collection date for primary outcome measure)
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
survival [ Time Frame: 3 year after surgery ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00679913 on ClinicalTrials.gov Archive Site
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
morbidity [ Time Frame: within 3 years after surgery ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Standardization of Surgery on the Pancreatic Cancer
Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pancreatic Cancer
  • Procedure: Standard pancreatoduodenectomy
    Standard pancreatoduodenectomy
  • Procedure: Extended pancreatoduodenectomy
    Extended pancreatoduodenectomy
    Other Name: Extended lymphadenectomy
  • Active Comparator: 1
    standard pancreatoduodenectomy
    Intervention: Procedure: Standard pancreatoduodenectomy
  • Active Comparator: 2
    extended pancreatoduodenectomy
    Intervention: Procedure: Extended pancreatoduodenectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00679913
H-0509-513-157
Yes
Sun-Whe Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Sun-Whe Kim, MD., PhD. Seoul National University Hospital
Seoul National University Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP