Ductal Adenocarcinoma, Left-sided Pancreatic Cancer
Conditions
Keywords
Splenectomy;, Spleen-preserving
Brief summary
When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.
Interventions
PROCEDURERadical Antegrade Modular Pancreatectomy with Splenectomy
PROCEDURERadical Antegrade Modular Pancreatectomy without splenectomy
distal pancreatectomy without pancreatectomy
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ductal adenocarcinoma 2. Age ≥20 and ≤80 3. General performance status: the Karnofsky score\> 70% or ECOG 0-1 4. Potentially Curative resection 5. Tumor size \< 3cm 6. Pancreatic cancer located on neck or body portion 7. No invasion to spleen or spleen hilum 8. No combined resection except Lt. adrenal gland 9. Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum
Exclusion criteria
1. Unresectable or locally advanced, metastatic case 2. Patients who do not want surgery 3. ASA (American society of anesthesiologists' physical status classification) score: ≥3 4. Patients with drug or alcohol addiction 5. Patients showing low compliance 6. Patients who not want to involve the clinical trial 7. Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding amount | 5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| average of pain score | admission period(about 5 days) | — |
| time interval to adjuvant treatment | admission period(about 5 days) | — |
| postoperative complication | admission period(about 5 days) | (e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.) |
Countries
South Korea
Outcome results
None listed