Pancreatic Cancer, Surgery
Conditions
Keywords
Radical Antegrade Modular Pancreatosplenectomy(RAMPS), Pancreatic Cancer, Minimal Invasive, ERAS, Disease Free Survival
Brief summary
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
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.
Interventions
PROCEDUREMinimal Invasive RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery
PROCEDUREOpen RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery
Sponsors
Beijing Municipal Health Commission
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posteroperative length of stay | Until patients were discharged | The days between the postoperative day-1 to the date when patient was eligible to be discharged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | during the surgery | Durtion of operation |
| Estimated blood loss | During the surgery | blood loss volume during the operation |
| Postoperative pain | Until patients were discharged | VAS score to measure the degree of postoperative pain |
| Overall Survival | more than 1 year | DFS means the survival duration after surgery. |
| Disease Free Survival | more than 1 year | DFS means the survival duration after surgery without any evidence of recurrence and metastasis. |
| R0 resection | up to approximately 2 weeks | the margin status of resection specimen |
| III-IV grade postoperative complication rate | No less than 3 months. | The ratio between patients with complication(s) and total patients in each groups. |
Countries
China
Contacts
Primary ContactHANYU ZHANG, M.D.
Backup ContactYatong Li, M.D.
Outcome results
None listed