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Two arms RCT is design, patients with pancreatic body or tail adenocarcinoma will be randomly assigned to the Radical Antegrade Modular Pancreaticosplenectomy (RAMPS) group or Standard Retrograde Pancreatosplenectomy (SRPS) group. The primary objective is to evaluate the effect of RAMPS on the overall survival of patients with resectable body and tail pancreatic ductal adenocarcinoma. And the secondary objective is to evaluate the disease-free survival, R0 resection rate, number of retrieved lymph nodes and perioperative outcomes like postoperative complication rate, severe complications, mortality and functional recovery time between the experimental group and control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAMPS group | Experimental | Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved. |
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| SRPS group | Active Comparator | Standard retrograde pancreatosplenectomy(SRPS) includes several key points. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical antegrade modular pancreatosplenectomy | Procedure | Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is "antegrade", which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called "posterior approach RAMPS". While in normal cases, left adrenal gland will be preserved. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival was defined as the time from surgery to either death or last follow-up. Patients will be observed or contacted every 2 months in the first 2 years after surgery and then every 3 months thereafter. Overall survival measurement will be based on patient's survival status and what is the date of death if the patient is not alive. | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | DFS was calculated from the date of surgery to the date of recurrence or last follow-up if recurrence did not occur. Recurrence was diagnosed by imaging examination like CT, MRI, PET-CT and PET-MRI. | 11 months |
| R0 resection rate |
| Measure | Description | Time Frame |
|---|---|---|
| operation time in minutes | Operation time means "skin to skin"time (from the surgeon start to incise the skin to the last suture of the skin) | 1 day |
| estimated blood loss in milliliters | Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanchi Weng, MD | Contact | +86-13774209138 | wyuanchi@126.com | |
| Zhen Huo, PhD | Contact | +86-15000082925 | generalsurgeon@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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The participant will not know which group they are assigned to, but the surgeons know which group they were randomly assigned to.
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| Standard retrograde pancreatosplenectomy | Procedure | Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is "retrograde", which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved. |
|
R0 resection was defined as absence of malignant cells within 1 mm from the resection margin using the Royal College of Pathologists definition. The assessment of the margin status will be done by pathologists. |
| 1 month |
| retrieved lymph nodes | The dissected lymph nodes will be sent to pathology department and the pathologists will separate the lymph nodes and give reports about how many lymph nodes are found and if the lymph nodes are positive or negative. | 1 month |
| 1 day |
| postoperative pancreatic fistula in percentage | According to the definition of International Study Group on Pancreatic Fistula(ISGPF) | 3 months |
| postpancreatectomy hemorrhage in percentage | Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery | 3 months |
| delayed gastric emptying in percentage | Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery | 3 months |
| Surgical site infection in percentage | Surgical site infections are defined by the Center for Disease Control and Prevention (CDC) definition, and diagnosed by positive pathogen culture in 2 weeks from surgery | 3 months |
| 30-day mortality in percentage | Any death within 30 days in postoperative period will be calculated | 1 month |
| 90-day mortality in percentage | Any death within 90 days in postoperative period will be calculated | 3 months |