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

May 18, 2022 updated by: Dai Menghua, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open-RAMPS
Patients with pancreatic cancer treated by traditional open surgery
Procedure: Open RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery
Experimental: MI-RAMPS
Patients with pancreatic cancer treated by laparoscopic surgery
Procedure: Minimal Invasive RAMPS
Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posteroperative length of stay
Time Frame: Until patients were discharged
The days between the postoperative day-1 to the date when patient was eligible to be discharged.
Until patients were discharged

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Beijing Municipal Health Commission

Investigators

  • Study Chair: Menghua Dai, M.D., PUMCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

November 24, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • daimh-RAMPS
  • No.2020-1-4011 (Other Grant/Funding Number: Beijing Capital Health Research and DEvelopment of Special)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD is not avaiable, but statistical data is avaiable

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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