LRAMPS Versus LDP in Selected Early-stage Left-sided Pancreatic Cancer

Fudan University

Status: Enrolling

Conditions: Left-sided Pancreatic Cancer

Treatments: Procedure: LDP; Procedure: LRAMPS

Study type: Interventional

Funder types: Other

Identifiers

NCT05939063

CSPAC-6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

LRAMPS group

Active Comparator group

Description:

Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery.

Treatment:

Procedure: LRAMPS

LDP group

Experimental group

Description:

Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery.

Treatment:

Procedure: LDP