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

Yonsei University1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Left-sided Pancreatic Cancer Ductal Adenocarcinoma

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Bleeding amount

Time frame: 5 hours

Secondary Outcomes

average of pain score

Time frame: admission period(about 5 days)

time interval to adjuvant treatment

Time frame: admission period(about 5 days)

postoperative complication

(e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.)

Time frame: admission period(about 5 days)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes