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Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Phase 3
20 Years
85 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

3 year after surgery

Safety Issue:


Principal Investigator

Sun-Whe Kim, MD., PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

December 2012

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • Pancreaticoduodenectomy
  • Extended lymphadenectomy
  • Pancreatic Neoplasms