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

November 19, 2016 updated by: Yonsei University
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAMPS
Radical Antegrade Modular Pancreatectomy with Splenectomy
Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy
Active Comparator: RAMP
Radical Antegrade Modular Pancreatectomy without splenectomy
Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy
distal pancreatectomy without pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding amount
Time Frame: 5 hours
5 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 19, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0138

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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