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

NCT01875198 | Terminated

• 1 other identifier: 4-2013-0138
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Left-sided Pancreatic Cancer; Ductal Adenocarcinoma

Keywords

Splenectomy;; Spleen-preserving

Outcome Measures

Primary Outcomes (1)

• Bleeding amount

  5 hours

Secondary Outcomes (3)

• average of pain score

  admission period(about 5 days)

• time interval to adjuvant treatment

  admission period(about 5 days)

• postoperative complication

  admission period(about 5 days)

Study Arms (2)

RAMPS

EXPERIMENTAL

Radical Antegrade Modular Pancreatectomy with Splenectomy

Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy

RAMP

ACTIVE COMPARATOR

Radical Antegrade Modular Pancreatectomy without splenectomy

Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy

Interventions

Radical Antegrade Modular Pancreatectomy with Splenectomy PROCEDURE

RAMPS

Radical Antegrade Modular Pancreatectomy without splenectomy PROCEDURE

distal pancreatectomy without pancreatectomy

RAMP

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22911134 BACKGROUND

MeSH Terms

Interventions

Splenectomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 11, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

KR (1)