Standardization of Surgery on the Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Standard pancreatoduodenectomy
* Procedure: Extended pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>standard pancreatoduodenectomy | Procedure: Standard pancreatoduodenectomy<br>* Standard pancreatoduodenectomy<br>|
| Active Comparator: 2<br>extended pancreatoduodenectomy | Procedure: Extended pancreatoduodenectomy<br>* Extended pancreatoduodenectomy<br>* Other names: Extended lymphadenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery | 2 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | 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 | within 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Pancreaticoduodenectomy, Extended lymphadenectomy