LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer
- Conditions
- Left-sided Pancreatic Cancer
- Interventions
- Procedure: LRAMPSProcedure: LDP
- Registration Number
- NCT05939063
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Clinically diagnosed as resectable left-sided pancreatic cancer before surgery.
- Imaging tumor diameter ≤ 4 cm.
- Located ≥ 1cm from the celiac trunk.
- Tumor didn't invade the fascial layer behind the pancreas.
- Be able to comply with research protocol.
- Voluntary participation and signed informed consent.
- Received neoadjuvant therapy.
- Presence of liver or other distant metastasis.
- Multifocal or recurrent disease.
- History of other malignancies.
- Simultaneously participating in other clinical trials.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LRAMPS group LRAMPS Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery. LDP group LDP Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery.
- Primary Outcome Measures
Name Time Method R0 transection margin rate From the date of surgery to 1 month after surgery. R0 transection margin rate diagnosed by postoperative pathological examination.
Lymph node positive rate From the date of surgery to 1 month after surgery. Lymph node positive rate diagnosed by postoperative pathological examination.
R0 retroperitoneal margin rate From the date of surgery to 1 month after surgery. R0 retroperitoneal margin rate diagnosed by postoperative pathological examination.
- Secondary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Through study completion, an average of 3 year. The time of surgery to the time of tumor recurrence or death.
Perioperative complication rate Within 90 days after surgery. Adverse events that occur during or after the surgery, including the incidence of postoperative complications reported according to the Clavien-Dindo classification, clinical relevant postoperative pancreatic fistula (POPF), postoperative pancreatic hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate and mortality rate within 90 days after surgery.
Life quality satisfaction evaluated according to EORTC C30 scale Through study completion, an average of 3 year. The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales.
Overall survival (OS) Through study completion, an average of 3 year. The time from the surgery to death from any cause.
Trial Locations
- Locations (1)
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China