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Standardization of Surgery on the Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00679913
First received: May 15, 2008
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: April 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Procedure: Standard pancreatoduodenectomy
Procedure: Extended pancreatoduodenectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between June 2006 and November 2009, 244 patients were enrolled in this study, after excluding the 9 patients who refused to participate after initial agreement. After enrollment, 44 patients were excluded due to having unresectable or metastatic tumors, as determined intraoperatively

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, some patients were excluded due to (1) unresectable condition or metastasis found during surgery; (2) surgical rule violation; (3) inadequate case report form; or (4) pathologic diagnosis other than conventional ductal adenocarcinoma.

Reporting Groups
  Description
Standard Pancreatoduodenectomy standard pancreatoduodenectomy Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA)
Extended Pancreatoduodenectomy extended pancreatoduodenectomy Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.

Participant Flow:   Overall Study
    Standard Pancreatoduodenectomy     Extended Pancreatoduodenectomy  
STARTED     101     99  
COMPLETED     83     86  
NOT COMPLETED     18     13  
Protocol Violation                 18                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Pancreatoduodenectomy

standard pancreatoduodenectomy

Standard pancreatoduodenectomy: Standard pancreatoduodenectomy In standard resection, the lymph nodes around the pancreas head (LN 13, 17) and gallbladder (LN 12c) were removed without nerve dissection around the hepatic or superior mesenteric artery (SMA).

Extended Pancreatoduodenectomy

extended pancreatoduodenectomy

Extended pancreatoduodenectomy: Extended pancreatoduodenectomy During extended resection, the lymph nodes around the common hepatic artery (LN 8), celiac axis (CA) (LN 9), peripancreatic area (LN 13, 17), hepatoduodenal ligament (LN 12), SMA (LN 14) and paraaortic area (LN16) between the CA and inferior mesenteric artery were dissected. All soft tissues around the hepatoduodenal ligament were completely dissected and skeletonized. The nerve plexus or ganglion on the right side of the CA and SMA was dissected semi-circumferentially.

Total Total of all reporting groups

Baseline Measures
    Standard Pancreatoduodenectomy     Extended Pancreatoduodenectomy     Total  
Number of Participants  
[units: participants]
  83     86     169  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 8.7     63.4  ± 9.5     62.7  ± 9.1  
Gender  
[units: participants]
     
Female     34     42     76  
Male     49     44     93  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival   [ Time Frame: 2 year after surgery ]

2.  Secondary:   Morbidity   [ Time Frame: within 2 years after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sun-Whe Kim, M.D., Ph.D., FACS
Organization: Seoul National University Hospital
phone: 82-2-2072-2310
e-mail: sunkim@plaza.snu.ac.kr


Publications:
Publications automatically indexed to this study:

Responsible Party: Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00679913     History of Changes
Other Study ID Numbers: H-0509-513-157
Study First Received: May 15, 2008
Results First Received: April 7, 2014
Last Updated: May 8, 2014
Health Authority: Korea: Food and Drug Administration