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

NCT01875198 — Not applicable, Terminated, 1 participants, Yonsei University

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Registry	NCT01875198
Status	Terminated - because of difficulties of enrolling appropriate participants
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1 (Actual)
Sponsor	Yonsei University (Other)
Conditions	Left-sided Pancreatic Cancer, Ductal Adenocarcinoma
Interventions	Radical Antegrade Modular Pancreatectomy with Splenectomy, Radical Antegrade Modular Pancreatectomy without splenectomy (Procedure)
Dates	start 2013-04-01, primary completion 2014-04-01, completion 2014-04-01, first posted 2013-06-11, last updated 2016-11-22
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
RAMPS	Experimental	Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy	Radical Antegrade Modular Pancreatectomy with Splenectomy
RAMP	Active comparator	Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy	Radical Antegrade Modular Pancreatectomy without splenectomy

Radical Antegrade Modular Pancreatectomy with Splenectomy (Procedure)
Radical Antegrade Modular Pancreatectomy without splenectomy (Procedure): distal pancreatectomy without pancreatectomy

+Outcome measures

Primary outcomes

Bleeding amount [5 hours]

Secondary outcomes

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.)

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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.)

+Locations (1)

Facility	City	Country	Status
Severance Hospital	Seoul, Seoul	South Korea

+Publications

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