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

Ductal Adenocarcinoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01875198
• Other study ID #: 4-2013-0138
• Status: Terminated
• Phase: N/A
• First received: May 28, 2013
• Last updated: November 19, 2016
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Ductal Adenocarcinoma
• Left-sided Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Radical Antegrade Modular Pancreatectomy with Splenectomy

• Radical Antegrade Modular Pancreatectomy without splenectomy
distal pancreatectomy without pancreatectomy

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding amount		5 hours	Yes
Secondary	average of pain score		admission period(about 5 days)	No
Secondary	time interval to adjuvant treatment		admission period(about 5 days)	No
Secondary	postoperative complication	(e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.)	admission period(about 5 days)	No