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

Study Overview
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Brief Summary
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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.

Conditions
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Left-sided Pancreatic Cancer, Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy
* Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAMPS<br>Radical Antegrade Modular Pancreatectomy with Splenectomy | Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy<br> <br> |
| Active Comparator: RAMP<br>Radical Antegrade Modular Pancreatectomy without splenectomy | Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy<br>* distal pancreatectomy without pancreatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding amount |  | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average of pain score |  | admission period(about 5 days) | 
| time interval to adjuvant treatment |  | admission period(about 5 days) | 
| postoperative complication | (e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.) | admission period(about 5 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Splenectomy;, Spleen-preserving