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

Pancreatic Cancer Clinical Trial

— MIRROR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770559
• Other study ID #: daimh-RAMPS
• Secondary ID: No.2020-1-4011
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2022
• Source: Peking Union Medical College Hospital
• Contact: HANYU ZHANG, M.D.
• Phone: 01069152600
• Email: medzhy5813[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

Procedure:
• Minimal Invasive RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery
• Open RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery

Locations

Country	Name	City	State
China	Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Municipal Health Commission

Country where clinical trial is conducted

China, 

References & Publications (7)

Cao F, Li J, Li A, Li F. Radical antegrade modular pancreatosplenectomy versus standard procedure in the treatment of left-sided pancreatic cancer: A systemic review and meta-analysis. BMC Surg. 2017 Jun 5;17(1):67. doi: 10.1186/s12893-017-0259-1. Review. — View Citation

Harrison LE, Klimstra DS, Brennan MF. Isolated portal vein involvement in pancreatic adenocarcinoma. A contraindication for resection? Ann Surg. 1996 Sep;224(3):342-7; discussion 347-9. — View Citation

Jimenez RE, Warshaw AL, Rattner DW, Willett CG, McGrath D, Fernandez-del Castillo C. Impact of laparoscopic staging in the treatment of pancreatic cancer. Arch Surg. 2000 Apr;135(4):409-14; discussion 414-5. — View Citation

Mitchem JB, Hamilton N, Gao F, Hawkins WG, Linehan DC, Strasberg SM. Long-term results of resection of adenocarcinoma of the body and tail of the pancreas using radical antegrade modular pancreatosplenectomy procedure. J Am Coll Surg. 2012 Jan;214(1):46-52. doi: 10.1016/j.jamcollsurg.2011.10.008. — View Citation

Ome Y, Hashida K, Yokota M, Nagahisa Y, Michio O, Kawamoto K. Laparoscopic radical antegrade modular pancreatosplenectomy for left-sided pancreatic cancer using the ligament of Treitz approach. Surg Endosc. 2017 Nov;31(11):4836-4837. doi: 10.1007/s00464-017-5561-6. Epub 2017 Apr 13. — View Citation

Park HJ, You DD, Choi DW, Heo JS, Choi SH. Role of radical antegrade modular pancreatosplenectomy for adenocarcinoma of the body and tail of the pancreas. World J Surg. 2014 Jan;38(1):186-93. doi: 10.1007/s00268-013-2254-8. — View Citation

Strasberg SM, Linehan DC, Hawkins WG. Radical antegrade modular pancreatosplenectomy procedure for adenocarcinoma of the body and tail of the pancreas: ability to obtain negative tangential margins. J Am Coll Surg. 2007 Feb;204(2):244-9. Epub 2007 Jan 4. — View Citation

Outcome

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