Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Location contact
Yuanchi Weng, MD.
CONTACT
Zhen Huo, PhD
CONTACT
NCT Number: NCT04253847
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
Yuanchi Weng, MD.
CONTACT
Zhen Huo, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 21 months
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.
Time frame: 11 months
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 day
Operation time means "skin to skin"time (from the surgeon start to incise the skin to the last suture of the skin)
Time frame: 1 day
Estimated blood loss will be evaluated based on the vacuum amount, gauze weight and liquid intake
Time frame: 3 months
According to the definition of International Study Group on Pancreatic Fistula(ISGPF)
Time frame: 3 months
Postpancreatectomy hemorrhage is defined by International Study Group on Pancreatic Surgery
Time frame: 3 months
Delayed gastric emptying is defined by International Study Group on Pancreatic Surgery
Time frame: 3 months
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
Time frame: 1 month
Any death within 30 days in postoperative period will be calculated
Time frame: 3 months
Any death within 90 days in postoperative period will be calculated
Contact information is provided by the study sponsor or research team.
Yuanchi Weng, MD
CONTACT
Zhen Huo, PhD
CONTACT
Ruijin Hospital
Other
Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma
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