Phase 3
N=200
Standardization of Surgery on the Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00679913 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Survival — 37; 31 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard pancreatoduodenectomy (Procedure); Extended pancreatoduodenectomy (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
37; 31 | — |
| SECONDARY Morbidity |
27; 37 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00679913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.