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because of difficulties of enrolling appropriate participants
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAMPS | Experimental | Radical Antegrade Modular Pancreatectomy with Splenectomy |
|
| RAMP | Active Comparator | Radical Antegrade Modular Pancreatectomy without splenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical Antegrade Modular Pancreatectomy with Splenectomy | Procedure |
| ||
| Radical Antegrade Modular Pancreatectomy without splenectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding amount | 5 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22911134 | Background | 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. |
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| Procedure |
distal pancreatectomy without pancreatectomy |
|
(e.g. postoperative pancreatic fistula, delayed gastric emptying, intra-abdominal abscess, postoperative bleeding, wound infection, etc.) |
| admission period(about 5 days) |
| ID | Term |
|---|---|
| D013156 | Splenectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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