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

Primary Purpose

Pancreatic Cancer, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minimal Invasive RAMPS
Open RAMPS
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Radical Antegrade Modular Pancreatosplenectomy(RAMPS), Pancreatic Cancer, Minimal Invasive, ERAS, Disease Free Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open-RAMPS

MI-RAMPS

Arm Description

Patients with pancreatic cancer treated by traditional open surgery

Patients with pancreatic cancer treated by laparoscopic surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
DFS means the survival duration after surgery.
Operative time
Durtion of operation
Estimated blood loss
blood loss volume during the operation
Postoperative pain
VAS score to measure the degree of postoperative pain
III-IV grade postoperative complication rate
The ratio between patients with complication(s) and total patients in each groups.
Disease Free Survival
DFS means the survival duration after surgery without any evidence of recurrence and metastasis.
R0 resection
the margin status of resection specimen

Full Information

First Posted
November 24, 2018
Last Updated
May 18, 2022
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Municipal Health Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03770559
Brief Title
The Therapeutic Evaluation(Both Short-term and Long-term Outcome) of Minimal Invasive Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer Patients
Acronym
MIRROR
Official Title
Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Municipal Health Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Surgery
Keywords
Radical Antegrade Modular Pancreatosplenectomy(RAMPS), Pancreatic Cancer, Minimal Invasive, ERAS, Disease Free Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-RAMPS
Arm Type
Active Comparator
Arm Description
Patients with pancreatic cancer treated by traditional open surgery
Arm Title
MI-RAMPS
Arm Type
Experimental
Arm Description
Patients with pancreatic cancer treated by laparoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Minimal Invasive RAMPS
Intervention Description
Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery
Intervention Type
Procedure
Intervention Name(s)
Open RAMPS
Intervention Description
Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery
Primary Outcome Measure Information:
Title
Posteroperative length of stay
Description
The days between the postoperative day-1 to the date when patient was eligible to be discharged.
Time Frame
Until patients were discharged
Secondary Outcome Measure Information:
Title
Overall Survival
Description
DFS means the survival duration after surgery.
Time Frame
more than 1 year
Title
Operative time
Description
Durtion of operation
Time Frame
during the surgery
Title
Estimated blood loss
Description
blood loss volume during the operation
Time Frame
During the surgery
Title
Postoperative pain
Description
VAS score to measure the degree of postoperative pain
Time Frame
Until patients were discharged
Title
III-IV grade postoperative complication rate
Description
The ratio between patients with complication(s) and total patients in each groups.
Time Frame
No less than 3 months.
Title
Disease Free Survival
Description
DFS means the survival duration after surgery without any evidence of recurrence and metastasis.
Time Frame
more than 1 year
Title
R0 resection
Description
the margin status of resection specimen
Time Frame
up to approximately 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old and older; Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail; Patients who are eligible and planned to be performed RAMPS procedure; Resectable or borderline resectable tumor by preoperative evaluation. Exclusion Criteria: Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery; ASA≥4； Patients who are not willing to be performed open and/or mi-RAMPS; Not pancreatic adenocarcinoma by posteroperative pathology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HANYU ZHANG, M.D.
Phone
01069152600
Email
medzhy5813@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yatong Li, M.D.
Phone
861069155992
Email
medzhy5813@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menghua Dai, M.D.
Organizational Affiliation
PUMCH
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Menghua Dai, M.D.
Email
daimh@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD is not avaiable, but statistical data is avaiable
Citations:
PubMed Identifier
8813262
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. doi: 10.1097/00000658-199609000-00010.
Results Reference
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PubMed Identifier
10768705
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. doi: 10.1001/archsurg.135.4.409.
Results Reference
background
PubMed Identifier
22192922
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.
Results Reference
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PubMed Identifier
28409377
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.
Results Reference
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PubMed Identifier
28583142
Citation
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.
Results Reference
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PubMed Identifier
17254928
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. doi: 10.1016/j.jamcollsurg.2006.11.002. Epub 2007 Jan 4.
Results Reference
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PubMed Identifier
24166024
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.
Results Reference
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PubMed Identifier
36185308
Citation
Dai M, Zhang H, Yang Y, Xiu D, Peng B, Sun B, Cao F, Wu Z, Wang L, Yuan C, Chen H, Wang Z, Tian X, Wang H, Liu W, Xu J, Liu Q, Zhao Y. The effect of minimally invasive or open radical antegrade modular pancreatosplenectomy on pancreatic cancer: A multicenter randomized clinical trial protocol. Front Oncol. 2022 Sep 15;12:965508. doi: 10.3389/fonc.2022.965508. eCollection 2022.
Results Reference
derived

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

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