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Brief Title: LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer
Official Title: Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
Study ID: NCT05939063
Brief Summary: This multicenter randomized controlled clinical trial proposed the criteria for selecting patients with early-stage left-sided pancreatic cancer and aimed to compare the perioperative and oncological outcomes of patients within the criteria who underwent laparoscopic radical antegrade modular pancreatosplenectomy versus laparoscopic distal pancreatosplenectomy.
Detailed Description: Although prospective comparative studies are lacking, laparoscopic distal pancreatosplenectomy (LDP) was considered to be feasible, safe, and oncologically equivalent for treating pancreatic ductal adenocarcinoma (PDAC). However, the extent of posterior resection and the oncological safety of achieving complete N1 lymph node resection in LDP remain uncertain. Strasberg proposed radical antegrade modular pancreatosplenectomy (RAMPS) for the treatment of resectable left-sided PDAC and confirmed that this technique can achieve negative margins and satisfactory survival. Given the oncological equivalence of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) and its advantages in short-term outcomes, several studies have assessed the feasibility of LRAMPS as the standard treatment for resectable left-sided PDAC. However, previous studies on LRAMPS have mostly included tumors staged T2 and above, and there is currently no research on the routine use of LRAMPS for early-stage tumors. We proposed the criteria for selecting patients with early-stage left-sided PDAC: (1) diameter ≤ 4 cm; (2) located ≥ 1 cm from the celiac trunk; (3) didn't invade the fascial layer behind the pancreas. This multicenter open-label randomized controlled clinical trial aims to compare the perioperative and oncological outcomes of patients within the criteria who underwent LRAMPS versus LDP.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Xianjun Yu, MD, PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaowu Xu, MD
Affiliation: Fudan University
Role: STUDY_DIRECTOR