The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients

Study Overview
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Brief Summary
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Pancreatic cancer is regarded as the king of cancer. It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS) is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the same surgical approach, the investigators are going to compare and discuss the advantages of laparoscopic and open RAMPS in the RCT study.

Detailed Description
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Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas. Meanwhile, laparoscopic surgery is proved to have many advantages in other operations. According to primary retrospective study of open and laparoscopic RAMPS, there was no statistically significant difference in the long-term follow-up situations between these two groups, indicating the safety of both this two surgical approaches. The investigators would like to promote a prospective RCT study, to give more evidences of the superiority of laparoscopic RAMPS.

Official Title
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Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial

Conditions
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Pancreatic Cancer, Surgery

Intervention / Treatment
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* Procedure: Minimal Invasive RAMPS
* Procedure: Open RAMPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old and older; Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail; Patients who are eligible and planned to be performed RAMPS procedure; Resectable or borderline resectable tumor by preoperative evaluation. Exclusion Criteria: Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery; ASA≥4； Patients who are not willing to be performed open and/or mi-RAMPS; Not pancreatic adenocarcinoma by posteroperative pathology.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: The development of study model was divided into 2 parrallel groups( Minimal Invasive RAMPS vs. Open RAMPS) based on the certain surgical procedure underwent
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open-RAMPS<br>Patients with pancreatic cancer treated by traditional open surgery | Procedure: Open RAMPS<br>* Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery<br>|
| Experimental: MI-RAMPS<br>Patients with pancreatic cancer treated by laparoscopic surgery | Procedure: Minimal Invasive RAMPS<br>* Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posteroperative length of stay | The days between the postoperative day-1 to the date when patient was eligible to be discharged. | Until patients were discharged | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | DFS means the survival duration after surgery. | more than 1 year | 
| Operative time | Durtion of operation | during the surgery | 
| Estimated blood loss | blood loss volume during the operation | During the surgery | 
| Postoperative pain | VAS score to measure the degree of postoperative pain | Until patients were discharged | 
| III-IV grade postoperative complication rate | The ratio between patients with complication(s) and total patients in each groups. | No less than 3 months. | 
| Disease Free Survival | DFS means the survival duration after surgery without any evidence of recurrence and metastasis. | more than 1 year | 
| R0 resection | the margin status of resection specimen | up to approximately 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical Antegrade Modular Pancreatosplenectomy(RAMPS), Pancreatic Cancer, Minimal Invasive, ERAS, Disease Free Survival