A Phase 3 interventional study of Standard pancreatoduodenectomy and Extended pancreatoduodenectomy in Pancreatic Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-06-06.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 244 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
standard pancreatoduodenectomy
Procedure: Standard pancreatoduodenectomy
extended pancreatoduodenectomy
Procedure: Extended pancreatoduodenectomy
Standard pancreatoduodenectomy
Extended pancreatoduodenectomy
Also known as: Extended lymphadenectomy
Survival
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
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
Time frame: within 2 years after surgery
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
| Milestone | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy |
|---|---|---|
| Started | 101 | 99 |
| Completed | 83 | 86 |
| Not completed | 18 | 13 |
| Withdrew: Protocol violation | 18 | 13 |
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
| participants | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy |
|---|---|---|
| Survival | 37 | 31 |
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
| participants | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy |
|---|---|---|
| Morbidity | 27 | 37 |
Collected over every 3 months after surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Pancreatoduodenectomy | — | 0/83 (0%) | 0/83 (0%) |
| Extended Pancreatoduodenectomy | — | 0/86 (0%) | 0/86 (0%) |
| Age, Continuous(years) | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy | Total |
|---|---|---|---|
| Mean | 62 ± 8.7 | 63.4 ± 9.5 | 62.7 ± 9.1 |
| Sex: Female, Male(Participants) | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy | Total |
|---|---|---|---|
| Female | 34 | 42 | 76 |
| Male | 49 | 44 | 93 |
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital