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Trial record 38 of 130 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT01875198
Recruitment Status : Terminated (because of difficulties of enrolling appropriate participants)
First Posted : June 11, 2013
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Left-sided Pancreatic Cancer Ductal Adenocarcinoma Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RAMPS
Radical Antegrade Modular Pancreatectomy with Splenectomy
Procedure: Radical Antegrade Modular Pancreatectomy with Splenectomy
Active Comparator: RAMP
Radical Antegrade Modular Pancreatectomy without splenectomy
Procedure: Radical Antegrade Modular Pancreatectomy without splenectomy
distal pancreatectomy without pancreatectomy




Primary Outcome Measures :
  1. Bleeding amount [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. average of pain score [ Time Frame: admission period(about 5 days) ]
  2. time interval to adjuvant treatment [ Time Frame: admission period(about 5 days) ]
  3. postoperative complication [ Time Frame: admission period(about 5 days) ]
    (e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875198


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01875198     History of Changes
Other Study ID Numbers: 4-2013-0138
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by Yonsei University:
Splenectomy;
Spleen-preserving
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases