Standardization of Surgery on the Pancreatic Cancer

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Procedure: Standard pancreatoduodenectomy; Procedure: Extended pancreatoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00679913

H-0509-513-157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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244 participants in 2 patient groups

1

Active Comparator group

Description:

standard pancreatoduodenectomy

Treatment:

Procedure: Standard pancreatoduodenectomy

2

Active Comparator group

Description:

extended pancreatoduodenectomy

Treatment:

Procedure: Extended pancreatoduodenectomy