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

Primary Purpose

Left-sided Pancreatic Cancer, Ductal Adenocarcinoma

Status

Terminated

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Radical Antegrade Modular Pancreatectomy with Splenectomy

Radical Antegrade Modular Pancreatectomy without splenectomy

About this trial

This is an interventional treatment trial for Left-sided Pancreatic Cancer focused on measuring Splenectomy;, Spleen-preserving

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAMPS

RAMP

Arm Description

Radical Antegrade Modular Pancreatectomy with Splenectomy

Radical Antegrade Modular Pancreatectomy without splenectomy

Outcomes

Primary Outcome Measures

Bleeding amount

Secondary Outcome Measures

average of pain score

time interval to adjuvant treatment

postoperative complication

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

Full Information

NCT ID

NCT01875198

First Posted

May 28, 2013

Last Updated

November 19, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01875198

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Terminated

Why Stopped

because of difficulties of enrolling appropriate participants

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Left-sided Pancreatic Cancer, Ductal Adenocarcinoma

Keywords

Splenectomy;, Spleen-preserving

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAMPS

Arm Type

Experimental

Arm Description

Radical Antegrade Modular Pancreatectomy with Splenectomy

Arm Title

RAMP

Arm Type

Active Comparator

Arm Description

Radical Antegrade Modular Pancreatectomy without splenectomy

Intervention Type

Procedure

Intervention Name(s)

Radical Antegrade Modular Pancreatectomy with Splenectomy

Intervention Type

Procedure

Intervention Name(s)

Radical Antegrade Modular Pancreatectomy without splenectomy

Intervention Description

distal pancreatectomy without pancreatectomy

Primary Outcome Measure Information:

Title

Bleeding amount

Time Frame

5 hours

Secondary Outcome Measure Information:

Title

average of pain score

Time Frame

admission period(about 5 days)

Title

time interval to adjuvant treatment

Time Frame

admission period(about 5 days)

Title

postoperative complication

Description

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

Time Frame

admission period(about 5 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22911134

Citation

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.

Results Reference

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

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