NCT01875198TerminatedNot Applicable
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Yonsei University
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Bleeding amount
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ductal adenocarcinoma
- •Age ≥20 and ≤80
- •General performance status: the Karnofsky score> 70% or ECOG 0-1
- •Potentially Curative resection
- •Tumor size < 3cm
- •Pancreatic cancer located on neck or body portion
- •No invasion to spleen or spleen hilum
- •No combined resection except Lt. adrenal gland
- •Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum
Exclusion Criteria
- •Unresectable or locally advanced, metastatic case
- •Patients who do not want surgery
- •ASA (American society of anesthesiologists' physical status classification) score: ≥3
- •Patients with drug or alcohol addiction
- •Patients showing low compliance
- •Patients who not want to involve the clinical trial
- •Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
Outcomes
Primary Outcomes
Bleeding amount
Time Frame: 5 hours
Secondary Outcomes
- 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))
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of splenectomy and pancreatectomy for gastric cancerGastric cancerJPRN-UMIN000007425Digestive Disease Center, Showa University Nothern Yokohama Hospital200
Unknown
Phase 3
Left Celiac Plexus Resection for Pancreatic Cancer at the Body and TailPancreatic CancerNCT02117895Fudan University180
Unknown
Not Applicable
Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?Healing Time of Post Operative Pancreatic FistulasNCT02220010Karolinska University Hospital60
Completed
Not Applicable
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal PancreatectomyDistal PancreatectomySpleen PreservationPostpancreatectomy HemorrhageNCT06084975Zhejiang University314
Completed
Not Applicable
Correlation Between Complications After Pancreaticoduodenectomy and MicrobiotaPancreatic CancerNCT04931069University Hospital, Toulouse39