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

Yonsei University

Status: Terminated

Conditions: Ductal Adenocarcinoma; Left-sided Pancreatic Cancer

Treatments: Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy; Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01875198

4-2013-0138

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

RAMPS

Experimental group

Description:

Radical Antegrade Modular Pancreatectomy with Splenectomy

Treatment:

Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy

RAMP

Active Comparator group

Description:

Radical Antegrade Modular Pancreatectomy without splenectomy

Treatment:

Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy