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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer; Surgery
• Interventions: Procedure: Open RAMPS; Procedure: Minimal Invasive RAMPS

• Registration Number: NCT03770559
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2018-11-24
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2020-07-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-20
• Primary Completion: 2023-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open-RAMPS	Open RAMPS	Patients with pancreatic cancer treated by traditional open surgery
MI-RAMPS	Minimal Invasive RAMPS	Patients with pancreatic cancer treated by laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Postoperative pain	Until patients were discharged	VAS score to measure the degree of postoperative pain
Estimated blood loss	During the surgery	blood loss volume during the operation
III-IV grade postoperative complication rate	No less than 3 months.	The ratio between patients with complication(s) and total patients in each groups.
R0 resection	up to approximately 2 weeks	the margin status of resection specimen
Operative time	during the surgery	Durtion of operation

Trial Locations

Locations (1)

Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; 🇨🇳 Beijing, China