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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Surgery; Pancreatic Cancer

Treatments: Procedure: Minimal Invasive RAMPS; Procedure: Open RAMPS

Study type: Interventional

Funder types: Other

Identifiers

NCT03770559

No.2020-1-4011 (Other Grant/Funding Number)

daimh-RAMPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

Open-RAMPS

Active Comparator group

Description:

Patients with pancreatic cancer treated by traditional open surgery

Treatment:

Procedure: Open RAMPS

MI-RAMPS

Experimental group

Description:

Patients with pancreatic cancer treated by laparoscopic surgery

Treatment:

Procedure: Minimal Invasive RAMPS