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Trial record 36 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

Standardization of Surgery on the Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00679913
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Procedure: Standard pancreatoduodenectomy
Procedure: Extended pancreatoduodenectomy
Enrollment 244
Recruitment Details 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 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.
Arm/Group Title Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 101 99
Completed 83 86
Not Completed 18 13
Reason Not Completed
Protocol Violation             18             13
Arm/Group Title Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 83 86 169
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 83 participants 86 participants 169 participants
62  (8.7) 63.4  (9.5) 62.7  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 169 participants
Female
34
  41.0%
42
  48.8%
76
  45.0%
Male
49
  59.0%
44
  51.2%
93
  55.0%
1.Primary Outcome
Title Survival
Hide Description comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
Time Frame 2 year after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 83 86
Measure Type: Number
Unit of Measure: participants
37 31
2.Secondary Outcome
Title Morbidity
Hide Description 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
Time Frame within 2 years after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Hide Arm/Group Description:

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 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

Overall Number of Participants Analyzed 83 86
Measure Type: Number
Unit of Measure: participants
27 37
Time Frame every 3 months after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Hide Arm/Group Description

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 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.

All-Cause Mortality
Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/86 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Pancreatoduodenectomy Extended Pancreatoduodenectomy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/86 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sun-Whe Kim, M.D., Ph.D., FACS
Organization: Seoul National University Hospital
Phone: 82-2-2072-2310
EMail: sunkim@plaza.snu.ac.kr
Layout table for additonal information
Responsible Party: Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00679913     History of Changes
Other Study ID Numbers: H-0509-513-157
First Submitted: May 15, 2008
First Posted: May 19, 2008
Results First Submitted: April 7, 2014
Results First Posted: June 6, 2014
Last Update Posted: June 6, 2014