Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 244
- Locations
- 1
- Primary Endpoint
- Survival
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Morbidity(within 2 years after surgery)
Investigators
Sun-Whe Kim
Professor
Seoul National University Hospital