Clinical trialNARecruiting
LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer
Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 1 October 2023
- Expected end
- 31 August 2028
- Enrollment
- 160 participants
- Sites
- 1
- Primary outcomes
- R0 retroperitoneal margin rate; R0 transection margin rate; Lymph node positive rate
- Sponsor
- Other
- Results posted
- No
- Last update
- 24 November 2023
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Papers 8
- BackgroundFeasibility of laparoscopic radical antegrade modular pancreatosplenectomy (RAMPS) as a standard treatment for distal r… DOI 10.1007/s00423-023-02942-0↗
- BackgroundRadical antegrade modular pancreatosplenectomy enhances local control of the disease in patients with left-sided pancre… DOI 10.1016/j.hpb.2022.08.004↗
- BackgroundComparison of laparoscopic versus open radical antegrade modular pancreatosplenectomy for pancreatic cancer: A systemat… DOI 10.1016/j.ijsu.2022.106676↗
- BackgroundComplications in Distal Pancreatectomy versus Radical Antegrade Modular Pancreatosplenectomy: A Disease Risk Score Anal… DOI 10.1007/s00268-022-06545-6↗
- BackgroundComparison of minimal invasive versus open radical antegrade modular pancreatosplenectomy (RAMPS) for pancreatic ductal… DOI 10.1007/s00464-020-07938-1↗
- BackgroundRadical antegrade modular pancreatosplenectomy for all pancreatic body and tail tumors: rationale and results. DOI 10.1007/s00423-019-01763-4↗
- BackgroundMinimally Invasive versus Open Distal Pancreatectomy for Ductal Adenocarcinoma (DIPLOMA): A Pan-European Propensity Sco… DOI 10.1097/sla.0000000000002561↗
- BackgroundMinimally invasive RAMPS in well-selected left-sided pancreatic cancer within Yonsei criteria: long-term (>median 3 yea… DOI 10.1007/s00464-014-3537-3↗