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NOT YET RECRUITING
NCT04253847
NA

RAMPS VS SRPS for Pancreatic Body and Tail Adenocarcinoma

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Radical Antegrade Modular Pancreatosplenectomy Versus Standard Retrograde Pancreatosplenectomy on the Survival and Prognosis for Resectable Body and Tail Pancreatic Ductal Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2020-02-15

Completion Date

2027-02-28

Last Updated

2020-02-05

Healthy Volunteers

No

Interventions

PROCEDURE

Radical antegrade modular pancreatosplenectomy

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.

PROCEDURE

Standard retrograde pancreatosplenectomy

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.

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China