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

Peking Union Medical College Hospital125 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Pancreatic Cancer Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years old and older; 2. Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail; 3. Patients who are eligible and planned to be performed RAMPS procedure; 4. Resectable or borderline resectable tumor by preoperative evaluation. Exclusion Criteria: 1. Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery; 2. ASA≥4； 3. Patients who are not willing to be performed open and/or mi-RAMPS; 4. Not pancreatic adenocarcinoma by posteroperative pathology.

Outcomes

Primary Outcomes

Posteroperative length of stay

The days between the postoperative day-1 to the date when patient was eligible to be discharged.

Time frame: Until patients were discharged

Secondary Outcomes

Overall Survival

DFS means the survival duration after surgery.

Time frame: more than 1 year

Operative time

Durtion of operation

Time frame: during the surgery

Estimated blood loss

blood loss volume during the operation

Time frame: During the surgery

Postoperative pain

VAS score to measure the degree of postoperative pain

Time frame: Until patients were discharged

III-IV grade postoperative complication rate

The ratio between patients with complication(s) and total patients in each groups.

Time frame: No less than 3 months.

Disease Free Survival

DFS means the survival duration after surgery without any evidence of recurrence and metastasis.

Time frame: more than 1 year

R0 resection

the margin status of resection specimen

Time frame: up to approximately 2 weeks