<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770559</url>
  </required_header>
  <id_info>
    <org_study_id>daimh-RAMPS</org_study_id>
    <secondary_id>No.2020-1-4011</secondary_id>
    <nct_id>NCT03770559</nct_id>
  </id_info>
  <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</brief_title>
  <acronym>MIRROR</acronym>
  <official_title>Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Municipal Health Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreatic cancer is regarded as &quot;the king of cancer&quot;. It is extremely malignant, with a low&#xD;
      sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is&#xD;
      very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS)&#xD;
      is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the&#xD;
      same surgical approach, the investigators are going to compare and discuss the advantages of&#xD;
      laparoscopic and open RAMPS in the RCT study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas.&#xD;
      Meanwhile, laparoscopic surgery is proved to have many advantages in other operations.&#xD;
      According to primary retrospective study of open and laparoscopic RAMPS, there was no&#xD;
      statistically significant difference in the long-term follow-up situations between these two&#xD;
      groups, indicating the safety of both this two surgical approaches. The investigators would&#xD;
      like to promote a prospective RCT study, to give more evidences of the superiority of&#xD;
      laparoscopic RAMPS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Posteroperative length of stay</measure>
    <time_frame>Until patients were discharged</time_frame>
    <description>The days between the postoperative day-1 to the date when patient was eligible to be discharged.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>more than 1 year</time_frame>
    <description>DFS means the survival duration after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>during the surgery</time_frame>
    <description>Durtion of operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>During the surgery</time_frame>
    <description>blood loss volume during the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>Until patients were discharged</time_frame>
    <description>VAS score to measure the degree of postoperative pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>III-IV grade postoperative complication rate</measure>
    <time_frame>No less than 3 months.</time_frame>
    <description>The ratio between patients with complication(s) and total patients in each groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>more than 1 year</time_frame>
    <description>DFS means the survival duration after surgery without any evidence of recurrence and metastasis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>R0 resection</measure>
    <time_frame>up to approximately 2 weeks</time_frame>
    <description>the margin status of resection specimen</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Open-RAMPS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with pancreatic cancer treated by traditional open surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MI-RAMPS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pancreatic cancer treated by laparoscopic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minimal Invasive RAMPS</intervention_name>
    <description>Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery</description>
    <arm_group_label>MI-RAMPS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open RAMPS</intervention_name>
    <description>Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery</description>
    <arm_group_label>Open-RAMPS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years old and older;&#xD;
&#xD;
          2. Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the&#xD;
             pancreatic body or tail;&#xD;
&#xD;
          3. Patients who are eligible and planned to be performed RAMPS procedure;&#xD;
&#xD;
          4. Resectable or borderline resectable tumor by preoperative evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with evidence of distant metastasis or advanced arterial invasion so that are&#xD;
             not able to continue radical surgery;&#xD;
&#xD;
          2. ASA≥4；&#xD;
&#xD;
          3. Patients who are not willing to be performed open and/or mi-RAMPS;&#xD;
&#xD;
          4. Not pancreatic adenocarcinoma by posteroperative pathology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menghua Dai, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>PUMCH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>HANYU ZHANG, M.D.</last_name>
    <phone>01069152600</phone>
    <email>medzhy5813@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yatong Li, M.D.</last_name>
    <phone>861069155992</phone>
    <email>medzhy5813@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Menghua Dai, M.D.</last_name>
      <email>daimh@pumch.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>8813262</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10768705</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22192922</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28409377</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28583142</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17254928</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24166024</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Dai Menghua</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Radical Antegrade Modular Pancreatosplenectomy(RAMPS)</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Minimal Invasive</keyword>
  <keyword>ERAS</keyword>
  <keyword>Disease Free Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD is not avaiable, but statistical data is avaiable</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770559
org study id: daimh-RAMPS
secondary id: No.2020-1-4011
nct id: NCT03770559
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Treatment
masking: None (Open Label)
measure: Posteroperative length of stay
time frame: Until patients were discharged
description: The days between the postoperative day-1 to the date when patient was eligible to be discharged.
measure: Overall Survival
time frame: more than 1 year
description: DFS means the survival duration after surgery.
measure: Operative time
time frame: during the surgery
description: Durtion of operation
measure: Estimated blood loss
time frame: During the surgery
description: blood loss volume during the operation
measure: Postoperative pain
time frame: Until patients were discharged
description: VAS score to measure the degree of postoperative pain
measure: III-IV grade postoperative complication rate
time frame: No less than 3 months.
description: The ratio between patients with complication(s) and total patients in each groups.
measure: Disease Free Survival
time frame: more than 1 year
description: DFS means the survival duration after surgery without any evidence of recurrence and metastasis.
measure: R0 resection
time frame: up to approximately 2 weeks
description: the margin status of resection specimen
arm group label: Open-RAMPS
arm group type: Active Comparator
description: Patients with pancreatic cancer treated by traditional open surgery
arm group label: MI-RAMPS
arm group type: Experimental
description: Patients with pancreatic cancer treated by laparoscopic surgery
intervention type: Procedure
intervention name: Minimal Invasive RAMPS
description: Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery
arm group label: MI-RAMPS
intervention type: Procedure
intervention name: Open RAMPS
description: Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery
arm group label: Open-RAMPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Menghua Dai, M.D.
role: Study Chair
affiliation: PUMCH
last name: HANYU ZHANG, M.D.
phone: 01069152600
email: medzhy5813@126.com
last name: Yatong Li, M.D.
phone: 861069155992
email: medzhy5813@126.com
facility: 
status: Recruiting
contact: 
country: China
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.
PMID: 8813262
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.
PMID: 10768705
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.
PMID: 22192922
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.
PMID: 28409377
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.
PMID: 28583142
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.
PMID: 17254928
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.
PMID: 24166024
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Dai Menghua
investigator title: Professor
mesh term: Pancreatic Neoplasms
sharing ipd: No
ipd description: IPD is not avaiable, but statistical data is avaiable