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LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer
NCT05939063 · Fudan University
In plain English
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Official title
Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Enrollment target: 160 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-10-01
Estimated completion: 2028-08-31
Last updated: 2023-11-24
Interventions
Procedure: LRAMPSProcedure: LDP
Primary outcomes
- • R0 retroperitoneal margin rate (From the date of surgery to 1 month after surgery.)
- • R0 transection margin rate (From the date of surgery to 1 month after surgery.)
- • Lymph node positive rate (From the date of surgery to 1 month after surgery.)
Sponsor
Fudan University · other
With: The Third Affiliated Hospital of Soochow University, Qilu Hospital of Shandong University
Contacts & investigators
ContactXianjun Yu, MD, PhD · contact · yuxianjun@fudanpci.org · +86-13801669875
ContactZheng Li, MD · contact · lizheng@fudanpci.org · +86-18521097686
InvestigatorXianjun Yu, MD, PhD · principal_investigator, Fudan University
InvestigatorXiaowu Xu, MD · study_director, Fudan University
All locations (1)
Department of Pancreatic Surgery, Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China