Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Pancreaticoduodenectomy, Extended lymphadenectomy
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.
Interventions
PROCEDUREStandard pancreatoduodenectomy
Standard pancreatoduodenectomy
PROCEDUREExtended pancreatoduodenectomy
Extended pancreatoduodenectomy
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 2 year after surgery | comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | within 2 years after surgery | 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 |
Countries
South Korea
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 83 |
| 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. | 86 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 18 | 13 |
Baseline characteristics
| Characteristic | Standard Pancreatoduodenectomy | Extended Pancreatoduodenectomy | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 8.7 | 63.4 years STANDARD_DEVIATION 9.5 | 62.7 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 34 Participants | 42 Participants | 76 Participants |
| Sex: Female, Male Male | 49 Participants | 44 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 86 |
| serious Total, serious adverse events | 0 / 83 | 0 / 86 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Pancreatoduodenectomy | Survival | 37 participants |
| Extended Pancreatoduodenectomy | Survival | 31 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
Time frame: within 2 years after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Pancreatoduodenectomy | Morbidity | 27 participants |
| Extended Pancreatoduodenectomy | Morbidity | 37 participants |