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| ID | Type | Description | Link |
|---|---|---|---|
| No.2020-1-4011 | Other Grant/Funding Number | Beijing Capital Health Research and DEvelopment of Special |
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| Name | Class |
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| Beijing Municipal Health Commission | OTHER_GOV |
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Pancreatic cancer is regarded as "the king of cancer". It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS) is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the same surgical approach, the investigators are going to compare and discuss the advantages of laparoscopic and open RAMPS in the RCT study.
Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas. Meanwhile, laparoscopic surgery is proved to have many advantages in other operations. According to primary retrospective study of open and laparoscopic RAMPS, there was no statistically significant difference in the long-term follow-up situations between these two groups, indicating the safety of both this two surgical approaches. The investigators would like to promote a prospective RCT study, to give more evidences of the superiority of laparoscopic RAMPS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-RAMPS | Active Comparator | Patients with pancreatic cancer treated by traditional open surgery |
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| MI-RAMPS | Experimental | Patients with pancreatic cancer treated by laparoscopic surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal Invasive RAMPS | Procedure | Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Posteroperative length of stay | The days between the postoperative day-1 to the date when patient was eligible to be discharged. | Until patients were discharged |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | DFS means the survival duration after surgery. | more than 1 year |
| Operative time | Durtion of operation | during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HANYU ZHANG, M.D. | Contact | 01069152600 | medzhy5813@126.com | |
| Yatong Li, M.D. | Contact | 861069155992 | medzhy5813@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Menghua Dai, M.D. | PUMCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China | Recruiting | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8813262 | Background | Harrison LE, Klimstra DS, Brennan MF. Isolated portal vein involvement in pancreatic adenocarcinoma. A contraindication for resection? Ann Surg. 1996 Sep;224(3):342-7; discussion 347-9. doi: 10.1097/00000658-199609000-00010. | |
| 10768705 | Background | Jimenez RE, Warshaw AL, Rattner DW, Willett CG, McGrath D, Fernandez-del Castillo C. Impact of laparoscopic staging in the treatment of pancreatic cancer. Arch Surg. 2000 Apr;135(4):409-14; discussion 414-5. doi: 10.1001/archsurg.135.4.409. |
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IPD is not avaiable, but statistical data is avaiable
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The development of study model was divided into 2 parrallel groups( Minimal Invasive RAMPS vs. Open RAMPS) based on the certain surgical procedure underwent
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| Open RAMPS | Procedure | Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery |
|
| Estimated blood loss | blood loss volume during the operation | During the surgery |
| Postoperative pain | VAS score to measure the degree of postoperative pain | Until patients were discharged |
| III-IV grade postoperative complication rate | The ratio between patients with complication(s) and total patients in each groups. | No less than 3 months. |
| Disease Free Survival | DFS means the survival duration after surgery without any evidence of recurrence and metastasis. | more than 1 year |
| R0 resection | the margin status of resection specimen | up to approximately 2 weeks |
|
| 22192922 | Background | Mitchem JB, Hamilton N, Gao F, Hawkins WG, Linehan DC, Strasberg SM. Long-term results of resection of adenocarcinoma of the body and tail of the pancreas using radical antegrade modular pancreatosplenectomy procedure. J Am Coll Surg. 2012 Jan;214(1):46-52. doi: 10.1016/j.jamcollsurg.2011.10.008. |
| 28409377 | Background | Ome Y, Hashida K, Yokota M, Nagahisa Y, Michio O, Kawamoto K. Laparoscopic radical antegrade modular pancreatosplenectomy for left-sided pancreatic cancer using the ligament of Treitz approach. Surg Endosc. 2017 Nov;31(11):4836-4837. doi: 10.1007/s00464-017-5561-6. Epub 2017 Apr 13. |
| 28583142 | Background | Cao F, Li J, Li A, Li F. Radical antegrade modular pancreatosplenectomy versus standard procedure in the treatment of left-sided pancreatic cancer: A systemic review and meta-analysis. BMC Surg. 2017 Jun 5;17(1):67. doi: 10.1186/s12893-017-0259-1. |
| 17254928 | Background | Strasberg SM, Linehan DC, Hawkins WG. Radical antegrade modular pancreatosplenectomy procedure for adenocarcinoma of the body and tail of the pancreas: ability to obtain negative tangential margins. J Am Coll Surg. 2007 Feb;204(2):244-9. doi: 10.1016/j.jamcollsurg.2006.11.002. Epub 2007 Jan 4. |
| 24166024 | Background | Park HJ, You DD, Choi DW, Heo JS, Choi SH. Role of radical antegrade modular pancreatosplenectomy for adenocarcinoma of the body and tail of the pancreas. World J Surg. 2014 Jan;38(1):186-93. doi: 10.1007/s00268-013-2254-8. |
| 36185308 | Derived | Dai M, Zhang H, Yang Y, Xiu D, Peng B, Sun B, Cao F, Wu Z, Wang L, Yuan C, Chen H, Wang Z, Tian X, Wang H, Liu W, Xu J, Liu Q, Zhao Y. The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol. Front Oncol. 2022 Sep 15;12:965508. doi: 10.3389/fonc.2022.965508. eCollection 2022. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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