Standardization of Surgery on the Pancreatic Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sun-Whe Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT00679913

First received: May 15, 2008

Last updated: September 14, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 15, 2008

Last Updated Date

September 14, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

survival [ Time Frame: 3 year after surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00679913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

morbidity [ Time Frame: within 3 years after surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Standardization of Surgery on the Pancreatic Cancer

Official Title ^ICMJE

Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

Procedure: Standard pancreatoduodenectomy
Standard pancreatoduodenectomy
Procedure: Extended pancreatoduodenectomy
Extended pancreatoduodenectomy

Other Name: Extended lymphadenectomy

Study Arm (s)

Active Comparator: 1
standard pancreatoduodenectomy

Intervention: Procedure: Standard pancreatoduodenectomy
Active Comparator: 2
extended pancreatoduodenectomy

Intervention: Procedure: Extended pancreatoduodenectomy

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

216

Estimated Completion Date

December 2012

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00679913

Other Study ID Numbers ^ICMJE

H-0509-513-157

Has Data Monitoring Committee

Yes

Responsible Party

Sun-Whe Kim, Seoul National University Hospital

Study Sponsor ^ICMJE

Seoul National University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sun-Whe Kim, MD., PhD.

Seoul National University Hospital

Information Provided By

Seoul National University Hospital

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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