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

NCT ID: NCT01875198

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-04-30

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.

Detailed Description

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Conditions

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Left-sided Pancreatic Cancer Ductal Adenocarcinoma

Keywords

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Splenectomy; Spleen-preserving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RAMPS

Radical Antegrade Modular Pancreatectomy with Splenectomy

Group Type EXPERIMENTAL

Radical Antegrade Modular Pancreatectomy with Splenectomy

Intervention Type PROCEDURE

RAMP

Radical Antegrade Modular Pancreatectomy without splenectomy

Group Type ACTIVE_COMPARATOR

Radical Antegrade Modular Pancreatectomy without splenectomy

Intervention Type PROCEDURE

distal pancreatectomy without pancreatectomy

Interventions

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Radical Antegrade Modular Pancreatectomy with Splenectomy

Intervention Type PROCEDURE

Radical Antegrade Modular Pancreatectomy without splenectomy

distal pancreatectomy without pancreatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Kim SH, Kang CM, Satoi S, Sho M, Nakamura Y, Lee WJ. Proposal for splenectomy-omitting radical distal pancreatectomy in well-selected left-sided pancreatic cancer: multicenter survey study. J Hepatobiliary Pancreat Sci. 2013 Mar;20(3):375-81. doi: 10.1007/s00534-012-0549-z.

Reference Type BACKGROUND
PMID: 22911134 (View on PubMed)

Other Identifiers

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4-2013-0138

Identifier Type: -

Identifier Source: org_study_id