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Clinical Trials/NCT01875198
NCT01875198TerminatedNot Applicable

Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer

Yonsei University2 sites in 1 country1 target enrollmentStarted: April 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
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

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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