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Completed

NCT Number: NCT00679913

Standardization of Surgery on the Pancreatic Cancer

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard pancreatoduodenectomy

Procedure

Standard pancreatoduodenectomy

Extended pancreatoduodenectomy

Procedure

Extended pancreatoduodenectomy

Other names: Extended lymphadenectomy

Primary outcomes

  1. 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

  1. Morbidity

    Time frame: within 2 years after surgery

    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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

Important dates

Study start
2005
Primary completion
2012
Study completion
2013
First posted
May 19, 2008
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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