Clinical trial NCT05939063: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left-sided Pancreatic Cancer
Keywords: Left-sided pancreatic cancer
Early-stage tumor
Laparoscopic radical antegrade modular pancreatosplenectomy
Laparoscopic distal pancreatosplecnectomy
Surgical complication
Oncologic prognosis
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Soochow University
name: Qilu Hospital of Shandong University
First posted: 2023-07-11
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: R0 retroperitoneal margin rate
timeFrame: From the date of surgery to 1 month after surgery.
measure: R0 transection margin rate
timeFrame: From the date of surgery to 1 month after surgery.
measure: Lymph node positive rate
timeFrame: From the date of surgery to 1 month after surgery.
Secondary outcomes:
measure: Perioperative complication rate
timeFrame: Within 90 days after surgery.
measure: Life quality satisfaction evaluated according to EORTC C30 scale
timeFrame: Through study completion, an average of 3 year.
measure: Recurrence-free survival (RFS)
timeFrame: Through study completion, an average of 3 year.
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 3 year.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xianjun Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xiaowu Xu, MD
role: STUDY_DIRECTOR
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