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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | standard pancreatoduodenectomy |
|
| 2 | Active Comparator | extended pancreatoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard pancreatoduodenectomy | Procedure | Standard pancreatoduodenectomy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun-Whe Kim, MD., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9790340 | Background | Pedrazzoli S, DiCarlo V, Dionigi R, Mosca F, Pederzoli P, Pasquali C, Kloppel G, Dhaene K, Michelassi F. Standard versus extended lymphadenectomy associated with pancreatoduodenectomy in the surgical treatment of adenocarcinoma of the head of the pancreas: a multicenter, prospective, randomized study. Lymphadenectomy Study Group. Ann Surg. 1998 Oct;228(4):508-17. doi: 10.1097/00000658-199810000-00007. | |
| 10235519 |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery | Posted | Number | participants | 2 year after surgery |
|
every 3 months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun-Whe Kim, M.D., Ph.D., FACS | Seoul National University Hospital | 82-2-2072-2310 | sunkim@plaza.snu.ac.kr |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Extended pancreatoduodenectomy |
| Procedure |
Extended pancreatoduodenectomy |
|
|
| Background |
| Yeo CJ, Cameron JL, Sohn TA, Coleman J, Sauter PK, Hruban RH, Pitt HA, Lillemoe KD. Pancreaticoduodenectomy with or without extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma: comparison of morbidity and mortality and short-term outcome. Ann Surg. 1999 May;229(5):613-22; discussion 622-4. doi: 10.1097/00000658-199905000-00003. |
| 16269290 | Background | Farnell MB, Pearson RK, Sarr MG, DiMagno EP, Burgart LJ, Dahl TR, Foster N, Sargent DJ; Pancreas Cancer Working Group. A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma. Surgery. 2005 Oct;138(4):618-28; discussion 628-30. doi: 10.1016/j.surg.2005.06.044. |
| 17318801 | Background | Michalski CW, Kleeff J, Wente MN, Diener MK, Buchler MW, Friess H. Systematic review and meta-analysis of standard and extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer. Br J Surg. 2007 Mar;94(3):265-73. doi: 10.1002/bjs.5716. |
| 24368638 | Derived | Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | 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 | Posted | Number | participants | within 2 years after surgery |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | 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. | 0 | 86 | 0 | 86 |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |