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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial

Conditions
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Left-sided Pancreatic Cancer

Intervention / Treatment
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* Procedure: LRAMPS
* Procedure: LDP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LRAMPS group<br>Patients who meet the inclusion and exclusion criteria will undergo laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) surgery. | Procedure: LRAMPS<br>* 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.<br>|
| Experimental: LDP group<br>Patients who meet the inclusion and exclusion criteria will undergo laparoscopic distal pancreatosplecnectomy (LDP) surgery. | Procedure: LDP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 retroperitoneal margin rate | R0 retroperitoneal margin rate diagnosed by postoperative pathological examination. | From the date of surgery to 1 month after surgery. | 
| R0 transection margin rate | R0 transection margin rate diagnosed by postoperative pathological examination. | From the date of surgery to 1 month after surgery. | 
| Lymph node positive rate | Lymph node positive rate diagnosed by postoperative pathological examination. | From the date of surgery to 1 month after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complication rate | Adverse events that occur during or after the surgery, including the incidence of postoperative complications reported according to the Clavien-Dindo classification, clinical relevant postoperative pancreatic fistula (POPF), postoperative pancreatic hemorrhage (PPH), delayed gastric emptying (DGE), reoperation rate and mortality rate within 90 days after surgery. | Within 90 days after surgery. | 
| Life quality satisfaction evaluated according to EORTC C30 scale | The patient's health-related quality of life after surgical intervention. It includes physical, emotional, and social aspects of a patient's well-being. This study evaluated quality of life using a telephone survey and the EORTC C30 scales. | Through study completion, an average of 3 year. | 
| Recurrence-free survival (RFS) | The time of surgery to the time of tumor recurrence or death. | Through study completion, an average of 3 year. | 
| Overall survival (OS) | The time from the surgery to death from any cause. | Through study completion, an average of 3 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left-sided pancreatic cancer, Early-stage tumor, Laparoscopic radical antegrade modular pancreatosplenectomy, Laparoscopic distal pancreatosplecnectomy, Surgical complication, Oncologic prognosis