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

Not Applicable

Terminated

• Conditions: Ductal Adenocarcinoma; Left-sided Pancreatic Cancer
• Interventions: Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy; Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy

• Registration Number: NCT01875198
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-19
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Read More

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.)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAMP	Radical Antegrade Modular Pancreatectomy without splenectomy	Radical Antegrade Modular Pancreatectomy without splenectomy
RAMPS	Radical Antegrade Modular Pancreatectomy with Splenectomy	Radical Antegrade Modular Pancreatectomy with Splenectomy

Primary Outcome Measures

Name	Time	Method
Bleeding amount	5 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of