2013-04
2014-04
2014-04
1
NCT01875198
Yonsei University
Yonsei University
INTERVENTIONAL
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2013-05-28 | N/A | 2016-11-19 |
2013-06-10 | N/A | 2016-11-22 |
2013-06-11 | N/A | 2016-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/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 with Splenectomy PROCEDURE: Radical Antegrade Modular Pancreatectomy without splenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Bleeding amount | 5 hours |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| average of pain score | admission period(about 5 days) | |
| time interval to adjuvant treatment | admission period(about 5 days) | |
| postoperative complication | (e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.) | admission period(about 5 days) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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