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

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

NCT ID: NCT05939063

Condition: Left-sided Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Left-sided pancreatic cancer
Early-stage tumor
Laparoscopic radical antegrade modular pancreatosplenectomy
Laparoscopic distal pancreatosplecnectomy
Surgical complication
Oncologic prognosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: LRAMPS
Description: For LRAMPS procedure, Gerota's fascia and perirenal fat capsule are removed, and the procedure is divided into anterior LRAMPS and posterior LRAMPS depending on whether the left adrenal gland is resected. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.
Arm group label: LRAMPS group

Intervention type: Procedure
Intervention name: LDP
Description: For LDP procedure, the dissection plane is located behind the fusion fascia. The N1 station lymph nodes (i.e., groups 10, 11, and 18) in the body and tail of the pancreas are removed. If the tumor is located near the pancreatic body, the No. 9 lymph node group is additionally removed.
Arm group label: LDP group

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Xianjun Yu, MD, PhD

Phone: +86-13801669875
Email: yuxianjun@fudanpci.org

Investigator:
Last name: Xianjun Yu, MD, PhD
Email: Principal Investigator

Investigator:
Last name: Xiaowu Xu, MD
Email: Sub-Investigator

Start date: October 1, 2023

Completion date: August 31, 2028

Lead sponsor:
Agency: Fudan University
Agency class: Other

Collaborator:
Agency: The Third Affiliated Hospital of Soochow University
Agency class: Other

Collaborator:
Agency: Qilu Hospital of Shandong University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05939063